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Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL

A Phase 1/2a Open-Label, Multi-Dose, Multi-Center Escalation and Exploratory Study of Cerdulatinib (PRT062070) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) or B-Cell or T-Cell Non-Hodgkin Lymphoma (NHL)

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01994382
Enrollment
260
Registered
2013-11-25
Start date
2013-08-30
Completion date
2020-12-15
Last updated
2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggressive NHL (a NHL), B-cell Non Hodgkin Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL/Indolent NHL), T-cell Lymphoma (PTCL and CTCL)

Keywords

Leukemia, Lymphocytic, Chronic, B Cell

Brief summary

This study will identify the highest dose, and assess the safety, of cerdulatinib (PRT062070) that may be given in participants with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or non-hodgkin lymphoma.

Detailed description

This is an open-label, Phase 1/2a, multi-dose, multi-center trial of orally administered cerdulatinib assessing safety, tolerability, and pharmacokinetic (PK) parameters conducted in 2 phases: * Phase 1: Dose-escalation portion, during which participants will be enrolled to receive a single-agent cerdulatinib at their assigned dose level starting at 15 milligrams (mg) once daily (QD), administered in increasing doses until the maximum tolerated dose (MTD)/maximum administered dose (MAD) is identified. * Phase 2a: Consisting of planned cohorts based on cancer type. The participants will receive single agent cerdulatinib at a starting dose of 35, 30, or 20 mg twice daily (BID) for 28-day cycles except for one of the cohorts, the participants will receive cerdulatinib plus intravenous (IV) rituximab at 375 mg/square meter (m\^2) for 28-day cycles.

Interventions

Oral capsule

BIOLOGICALRituximab

IV infusion

Sponsors

Portola Pharmaceuticals
CollaboratorINDUSTRY
Alexion Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Phase 1 Inclusion • Participant at least 18 years of age with histologically confirmed CLL/SLL or B-cell non-Hodgkin lymphoma (diffuse large B-cell lymphoma \[DLBCL\], FL, mantle cell lymphoma \[MCL\], marginal zone lymphoma \[MZL\], lymphoplasmacytic lymphoma). Phase 2a Inclusion * Histological evidence: FL Grade 1-3A, with relapsed or refractory disease; aggressive NHL (aNHL), defined as DLBCL, FL Grade 3B, MCL, and transformed NHL with relapsed disease; CLL/SLL, peripheral T-cell lymphoma (PTCL), or cutaneous T-cell lymphoma (CTCL) (with mycosis fungoides \[MF\]/Sézary Syndrome \[SS\]) with relapsed or refractory disease * Received B-cell receptor (BCR) and/or BCL2 inhibitors and were intolerant or had relapsed/refractory disease afterwards * Prior treatment for lymphoid malignancy for progressive /refractory disease * ≥1 prior regimen (minimum 2 cycles) with antibody conjugate/cytotoxic chemotherapy. * Measurable disease defined as: ≥1 lesion that measures ≥1.5 centimeter (cm) single dimension via computed tomography (CT), CT/positive-emission tomography (PET) with nodal or mass lesions; quantifiable circulating tumor cells; and for CTCL: Modified Severity Weighted Assessment Tool (mSWAT) \>0 * Ability to provide diagnostic reports General Inclusion * Eastern Cooperative Oncology Group (ECOG) Score of 0 or 1 * Hematologic absolute neutrophil count (ANC) \>1000/microliter (uL) and platelet \>75,000/uL * Creatinine levels as specified by Investigator * Bilirubin \<2.0 mg/deciliter \[dL\] (if Gilberts then \<2.5 mg/dL) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \<2.5\*ULN

Exclusion criteria

* Richter's syndrome, Burkitt's lymphoma, or Burkitt-like Lymphoma (transformed DLBCL from follicular NHL are eligible) * Prior transplant with stem cell infusion within 90 days of Day 1 or active graft-versus-host treatment within 8 weeks of Day 1 * Prior therapy with Spleen Tyrosine Kinase (SYK) inhibitors * Chronic treatment with strong CYP3A4 inhibitor/inducer * Known lymphomatous involvement of the central nervous system (CNS) * Persistent, unresolved National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 ≥Grade 2, previous drug-related toxicity (except alopecia, erectile impotence, hot flashes, libido, neuropathy). * Prior monoclonal antibody (including alemtuzumab), radioimmunoconjugate, antibody drug conjugate, phototherapy, radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any test agent within 3 weeks of Day 1 * For CTCL: (total skin electron beam therapy \[TSEBT\]) within 12 weeks, or initiation of topical steroid, nitrogen mustard, or topical retinoid within 2 weeks. Stable topical regimen for ≥4 weeks prior to Day 1 allowed. * Known carrier or infection for human immunodeficiency virus (HIV)/hepatitis B or C. If hepatitis C virus (HCV) antibody (ab)+, must be polymerase chain reaction (PCR)- to be eligible. If hepatitis B virus (HBV) ab+, must be hepatitis B surface antigen (HBsAg)- or undetectable HBV deoxyribonucleic acid (DNA) to be eligible. * Active infection requiring systemic treatment, * Significant gastrointestinal (GI) disease, previous major gastric/bowel surgery, difficulty swallowing, or malabsorption syndrome * Major surgery within 4 weeks * Previous malignancies within 2 years unless relapse risk is small (\<5%). * Current use of systemic steroids \>20 mg QD prednisone (or equivalent) * Breastfeeding or pregnant (intention to become) females or participation in other clinical trials

Design outcomes

Primary

MeasureTime frameDescription
Phase 1: Number of Participants With a Dose Limiting Toxicity (DLT)Baseline up to Day 28 of Cycle 1 (cycle = 21 days or 28 days)DLT was defined as any of the following toxicities, possibly or probably related to cerdulatinib, and clinically significant (in the judgement of Investigator): -Febrile neutropenia (absolute neutrophil count \<1000/microliter \[μL\] and temperature ≥38.5°Celcius). -Grade 4 neutropenia for \>5 days. -Grade 4 thrombocytopenia with or without bleeding. -Grade 3 thrombocytopenia with bleeding. -Grade 4 anemia, unexplained by underlying disease. -Grade 3 or greater nausea, vomiting, or diarrhea if persistent despite optimal antiemetic or anti-diarrheal therapy. -Grade 3 or greater increase in transaminases lasting \>5 days. -Grade 3 or greater fatigue persisting \>7 days in absence of any other underlying cause. -Any other Grade 3 or greater non-hematologic toxicity (except fatigue as noted above) considered clinically significant by Investigator. -Toxicity of any grade resulting in dose delay of \>7 days. -Toxicity resulting in study drug discontinuation prior to completion of Cycle 1.
Phase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the InvestigatorBaseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])CR included: -Via a positron emission tomography (PET)/computed tomography (CT) scan, score of 1 (no uptake above background), 2 (uptake of \<mediastinum), or 3 (uptake of \>mediastinum but \<liver) for lymph nodes and extralymphatic sites; no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. -Via CT scan, target nodes/nodal masses regressed to \<1.5 centimeters (cm) in longest transverse diameter of a lesion (LDi); no extralymphatic sites of disease; organ enlargement has regressed to normal; and bone marrow was normal by morphology and if indeterminate, immunohistochemistry was negative. PR included: -Via a PET/CT scan, score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and residual masses of any size. -Via CT scan, \>50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites.

Secondary

MeasureTime frameDescription
Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])An AE is any untoward medical occurrence, which may or may not have a causal relationship to the study drug, including: unfavorable and unintended sign, symptom, or disease temporally associated with the use of the study drug; any newly occurring event or exacerbation of previous condition (for example, increase in severity or frequency) since the administration of study drug; recurrence of an intermittent medical condition not present at baseline; any deterioration in a laboratory value or other clinical test that is associated with symptoms or leads to a change in study treatment or concomitant treatment or discontinuation from study drug; and AEs related to a study intervention. An SAE is an AE that is fatal, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
Phase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibCycle (C)1 Day (D)1: predose (0), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, and 72 hours postdose (except 15mg QD); C1D1: 0, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose (15mg QD); C2D1: 0, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose (all doses)
Phase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the InvestigatorBaseline up to End of Treatment (up to last day of Cycle 10 [cycle = 21 days or 28 days])CR included: -Via a PET/CT scan, score of 1 (no uptake above background), 2 (uptake of \<mediastinum), or 3 (uptake of \>mediastinum but \<liver) for lymph nodes and extralymphatic sites; no new lesions; and no evidence of FDG-avid disease in bone marrow. -Via CT scan, target nodes/nodal masses regressed to \<1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement has regressed to normal; and bone marrow was normal by morphology and if indeterminate, immunohistochemistry was negative. PR included: -Via a PET/CT scan, a score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and residual masses of any size. -Via CT scan, \>50% decrease in the sum of the product of perpendicular diameters for multiple lesion of up to 6 target measurable nodes and extranodal sites.
Phase 2a: Number of Participants Achieving Clinical BenefitBaseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])Clinical benefit was defined as achieving SD or better, as assessed by the Investigator. SD included: -Via a PET/CT scan, a score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with no significant change in FDG uptake from baseline at interim or end of treatment; no new lesions; and no change from baseline in bone marrow. -Via CT scan, \<50% decrease from baseline in sum of products of the greatest perpendicular diameters (SPD) of up to 6 dominant, measurable nodes and extranodal sites; no increase consistent with progression in nonmeasured lesions or organ enlargement; and no new lesions.
Phase 2a: Number of Participants Achieving Dominant Mass Response (DMR)Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])DMR was defined as achieving a ≥50% decrease from baseline in the SPD of the target nodal and extranodal lesions. SPD at a visit was considered missing if any target lesion was not evaluated.
Phase 2a: Median Time to Progression-Free Survival (PFS)Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])PFS=(first documentation of disease progression \[DP\] or death \[whichever occurred first\]-study drug first dose date+1)/30.4375 in months. PFS right censored for 1 of these conditions: 1) no baseline disease assessments; 2) starting new anticancer therapy before documented DP/death; 3) DP/death immediately after \>6 months since last disease assessment (or \>12 months if after last cycle); & alive without documented DP. 95% confidence interval estimated using Brookmeyer method. DP included: -Via a PET/CT scan, score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with uptake increase in intensity, new FDG-avid foci, & no nonmeasured lesions. -Via CT, abnormal individual node/lesion with significant LDi or shortest axis perpendicular to LDi increase; prior splenomegaly, \>50% splenic length increase; if no prior splenomegaly, ≥2 cm splenic length increase; new or recurrent splenomegaly; new/clear progression of preexisting nonmeasured lesions.
Phase 1: Number of Participants Achieving Clinical BenefitBaseline up to End of Treatment (up to last day of Cycle 10 [cycle = 21 days or 28 days])Clinical benefit was defined as achieving stable disease (SD) or better, as assessed by the Investigator. SD included: -Via a PET/CT scan, a score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with no significant change in FDG uptake from baseline at interim or end of treatment; no new lesions; and no change from baseline in bone marrow. -Via CT scan, \<50% decrease from baseline in sum of products of the greatest perpendicular diameters (SPD) of up to 6 dominant, measurable nodes and extranodal sites; no increase consistent with progression in nonmeasured lesions or organ enlargement; and no new lesions.

Countries

United States

Participant flow

Recruitment details

This was an open-label study with 2 phases.

Pre-assignment details

Phase 1: dose-escalation portion of study, participants received doses of cerdulatinib at assigned regimen. Phase 2a: participants were enrolled into cohorts based on cancer type and received single agent cerdulatinib except for 1 cohort, participants received cerdulatinib+rituximab. Three participants in Phase 1 rolled over to Phase 2; their data are included in respective arms in both phases. Therefore, the data are included twice in the Totals for Participant Flow & Baseline Characteristics.

Participants by arm

ArmCount
Phase 1: Cerdulatinib 15 mg QD
Participants received oral cerdulatinib at 15 mg QD starting on Day 1 in 21-day cycles for up to 10 cycles.
3
Phase 1: Cerdulatinib 30 mg QD
Participants received oral cerdulatinib at 30 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
6
Phase 1: Cerdulatinib 45 mg QD
Participants received oral cerdulatinib at 45 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
7
Phase 1: Cerdulatinib 15 mg BID
Participants received oral cerdulatinib at 15 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
3
Phase 1: Cerdulatinib 40 mg QD
Participants received oral cerdulatinib at 40 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
3
Phase 1: Cerdulatinib 20 mg BID
Participants received oral cerdulatinib at 20 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
3
Phase 1: Cerdulatinib 50 mg QD
Participants received oral cerdulatinib at 50 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
4
Phase 1: Cerdulatinib 65 mg QD
Participants received oral cerdulatinib at 65 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
6
Phase 1: Cerdulatinib 100 mg QD
Participants received oral cerdulatinib at 100 mg on Day 1 and then QD starting on Day 4 in 28-day cycles for up to 10 cycles.
3
Phase 1: Cerdulatinib 45 mg BID
Participants received oral cerdulatinib at 45 mg on Day 1 and then BID starting on Day 4 in 28-day cycles for up to 10 cycles.
5
Phase 2a: Cerdulatinib (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
42
Phase 2a: Cerdulatinib (MZL/WM Cohort)
Participants with MZL/WM received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
12
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)
Participants with FL received oral cerdulatinib at starting doses of 30 or 20 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID. Participants also received IV injections of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, and 10.
26
Phase 2a: Cerdulatinib (aNHL Cohort)
Participants with aNHL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
6
Phase 2a: Cerdulatinib (CLL/SLL Cohort)
Participants with CLL/SLL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
28
Phase 2a: Cerdulatinib (PTCL Cohort)
Participants with PTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
65
Phase 2a: Cerdulatinib (CTCL Cohort)
Participants with CTCL received oral cerdulatinib at starting doses of 35 or 30 mg BID on Day 1 in 28-day cycles for up to 10 cycles. Doses of cerdulatinib could have been reduced to a minimum dose of 15 mg BID or increased to a maximum dose of 30 mg BID, when applicable.
41
Total263

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012FG013FG014FG015FG016
Overall StudyAdverse Event0120000000152731763
Overall StudyDeath00001000110000010
Overall StudyInformed consent withdrawn00000010000000000
Overall StudyLost to Follow-up00000000001000000
Overall StudyOther than specified00000000002020044
Overall StudyParticipants rolled over into expanded access program (NCT04757259)00000000002070032
Overall StudyPhysician Decision01000000003110142
Overall StudyProgressive disease34432336221387364428
Overall StudyProtocol violation/noncompliance00000000000100002
Overall StudyRolled over to Phase 2a00100000020000000
Overall StudyWithdrawal by Subject00000000006020430

Baseline characteristics

CharacteristicTotalPhase 1: Cerdulatinib 30 mg QDPhase 1: Cerdulatinib 45 mg QDPhase 1: Cerdulatinib 15 mg BIDPhase 1: Cerdulatinib 40 mg QDPhase 1: Cerdulatinib 15 mg QDPhase 1: Cerdulatinib 20 mg BIDPhase 1: Cerdulatinib 50 mg QDPhase 1: Cerdulatinib 65 mg QDPhase 1: Cerdulatinib 100 mg QDPhase 1: Cerdulatinib 45 mg BIDPhase 2a: Cerdulatinib (FL Cohort)Phase 2a: Cerdulatinib (MZL/WM Cohort)Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)Phase 2a: Cerdulatinib (aNHL Cohort)Phase 2a: Cerdulatinib (CLL/SLL Cohort)Phase 2a: Cerdulatinib (PTCL Cohort)Phase 2a: Cerdulatinib (CTCL Cohort)
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
143 Participants5 Participants4 Participants3 Participants0 Participants2 Participants1 Participants4 Participants5 Participants2 Participants4 Participants19 Participants5 Participants13 Participants4 Participants20 Participants32 Participants20 Participants
Age, Categorical
Between 18 and 65 years
120 Participants1 Participants3 Participants0 Participants3 Participants1 Participants2 Participants0 Participants1 Participants1 Participants1 Participants23 Participants7 Participants13 Participants2 Participants8 Participants33 Participants21 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants2 Participants1 Participants1 Participants0 Participants1 Participants6 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
232 Participants6 Participants7 Participants3 Participants3 Participants3 Participants2 Participants4 Participants6 Participants3 Participants3 Participants37 Participants10 Participants24 Participants5 Participants26 Participants53 Participants37 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
18 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants3 Participants1 Participants1 Participants1 Participants1 Participants6 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
6 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants2 Participants0 Participants1 Participants0 Participants1 Participants2 Participants0 Participants
Race (NIH/OMB)
Black or African American
29 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants2 Participants0 Participants3 Participants10 Participants11 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
13 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants2 Participants0 Participants1 Participants0 Participants1 Participants5 Participants4 Participants
Race (NIH/OMB)
White
211 Participants6 Participants7 Participants3 Participants2 Participants3 Participants3 Participants4 Participants6 Participants3 Participants4 Participants36 Participants11 Participants22 Participants6 Participants23 Participants48 Participants24 Participants
Sex: Female, Male
Female
97 Participants2 Participants3 Participants2 Participants0 Participants0 Participants2 Participants1 Participants1 Participants0 Participants2 Participants16 Participants4 Participants9 Participants1 Participants12 Participants24 Participants18 Participants
Sex: Female, Male
Male
166 Participants4 Participants4 Participants1 Participants3 Participants3 Participants1 Participants3 Participants5 Participants3 Participants3 Participants26 Participants8 Participants17 Participants5 Participants16 Participants41 Participants23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
EG012
affected / at risk
EG013
affected / at risk
EG014
affected / at risk
EG015
affected / at risk
EG016
affected / at risk
deaths
Total, all-cause mortality
0 / 30 / 60 / 70 / 31 / 30 / 30 / 40 / 61 / 31 / 50 / 420 / 120 / 260 / 60 / 281 / 650 / 41
other
Total, other adverse events
3 / 36 / 67 / 73 / 33 / 33 / 34 / 46 / 63 / 35 / 542 / 4212 / 1226 / 266 / 628 / 2865 / 6541 / 41
serious
Total, serious adverse events
0 / 32 / 64 / 70 / 31 / 30 / 32 / 42 / 62 / 33 / 522 / 422 / 127 / 263 / 617 / 2842 / 6521 / 41

Outcome results

Primary

Phase 1: Number of Participants With a Dose Limiting Toxicity (DLT)

DLT was defined as any of the following toxicities, possibly or probably related to cerdulatinib, and clinically significant (in the judgement of Investigator): -Febrile neutropenia (absolute neutrophil count \<1000/microliter \[μL\] and temperature ≥38.5°Celcius). -Grade 4 neutropenia for \>5 days. -Grade 4 thrombocytopenia with or without bleeding. -Grade 3 thrombocytopenia with bleeding. -Grade 4 anemia, unexplained by underlying disease. -Grade 3 or greater nausea, vomiting, or diarrhea if persistent despite optimal antiemetic or anti-diarrheal therapy. -Grade 3 or greater increase in transaminases lasting \>5 days. -Grade 3 or greater fatigue persisting \>7 days in absence of any other underlying cause. -Any other Grade 3 or greater non-hematologic toxicity (except fatigue as noted above) considered clinically significant by Investigator. -Toxicity of any grade resulting in dose delay of \>7 days. -Toxicity resulting in study drug discontinuation prior to completion of Cycle 1.

Time frame: Baseline up to Day 28 of Cycle 1 (cycle = 21 days or 28 days)

Population: The Safety Analysis Population included participants who received at least 1 dose of study drug. Only data from participants in Phase 1 cohorts (arms) were applicable and evaluated for this Outcome Measure. Evaluable participants for this Outcome Measure must have received 80% of doses in Cycle 1 or withdrawn from study drug due to drug-related toxicity.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 1: Cerdulatinib 15 mg QDPhase 1: Number of Participants With a Dose Limiting Toxicity (DLT)0 Participants
Phase 1: Cerdulatinib 30 mg QDPhase 1: Number of Participants With a Dose Limiting Toxicity (DLT)0 Participants
Phase 1: Cerdulatinib 45 mg QDPhase 1: Number of Participants With a Dose Limiting Toxicity (DLT)0 Participants
Phase 1: Cerdulatinib 15 mg BIDPhase 1: Number of Participants With a Dose Limiting Toxicity (DLT)0 Participants
Phase 1: Cerdulatinib 40 mg QDPhase 1: Number of Participants With a Dose Limiting Toxicity (DLT)0 Participants
Phase 1: Cerdulatinib 20 mg BIDPhase 1: Number of Participants With a Dose Limiting Toxicity (DLT)0 Participants
Phase 1: Cerdulatinib 50 mg QDPhase 1: Number of Participants With a Dose Limiting Toxicity (DLT)0 Participants
Phase 1: Cerdulatinib 65 mg QDPhase 1: Number of Participants With a Dose Limiting Toxicity (DLT)0 Participants
Phase 1: Cerdulatinib 100 mg QDPhase 1: Number of Participants With a Dose Limiting Toxicity (DLT)1 Participants
Phase 1: Cerdulatinib 45 mg BIDPhase 1: Number of Participants With a Dose Limiting Toxicity (DLT)2 Participants
Primary

Phase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator

CR included: -Via a positron emission tomography (PET)/computed tomography (CT) scan, score of 1 (no uptake above background), 2 (uptake of \<mediastinum), or 3 (uptake of \>mediastinum but \<liver) for lymph nodes and extralymphatic sites; no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. -Via CT scan, target nodes/nodal masses regressed to \<1.5 centimeters (cm) in longest transverse diameter of a lesion (LDi); no extralymphatic sites of disease; organ enlargement has regressed to normal; and bone marrow was normal by morphology and if indeterminate, immunohistochemistry was negative. PR included: -Via a PET/CT scan, score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and residual masses of any size. -Via CT scan, \>50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites.

Time frame: Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])

Population: The Efficacy Analysis Population included all participants who took at least 1 dose of study drug and had at least 1 post-baseline Investigator response assessment. Only the cohorts (arms) with participants with FL or with PTCL were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 1: Cerdulatinib 15 mg QDPhase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator12 Participants
Phase 1: Cerdulatinib 30 mg QDPhase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator6 Participants
Phase 1: Cerdulatinib 45 mg QDPhase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator15 Participants
Phase 1: Cerdulatinib 15 mg BIDPhase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator5 Participants
Phase 1: Cerdulatinib 40 mg QDPhase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator14 Participants
Phase 1: Cerdulatinib 20 mg BIDPhase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator0 Participants
Phase 1: Cerdulatinib 50 mg QDPhase 2a: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator7 Participants
Secondary

Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)

An AE is any untoward medical occurrence, which may or may not have a causal relationship to the study drug, including: unfavorable and unintended sign, symptom, or disease temporally associated with the use of the study drug; any newly occurring event or exacerbation of previous condition (for example, increase in severity or frequency) since the administration of study drug; recurrence of an intermittent medical condition not present at baseline; any deterioration in a laboratory value or other clinical test that is associated with symptoms or leads to a change in study treatment or concomitant treatment or discontinuation from study drug; and AEs related to a study intervention. An SAE is an AE that is fatal, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or a congenital anomaly/birth defect.

Time frame: Baseline up to End of Study (up to 30 days after last dose in Cycle 10 [cycle = up to 28 days])

Population: The Safety Analysis Population included participants who received at least 1 dose of study drug.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 1: Cerdulatinib 15 mg QDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE3 Participants
Phase 1: Cerdulatinib 15 mg QDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE0 Participants
Phase 1: Cerdulatinib 30 mg QDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE6 Participants
Phase 1: Cerdulatinib 30 mg QDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE2 Participants
Phase 1: Cerdulatinib 45 mg QDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE7 Participants
Phase 1: Cerdulatinib 45 mg QDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE4 Participants
Phase 1: Cerdulatinib 15 mg BIDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE3 Participants
Phase 1: Cerdulatinib 15 mg BIDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE0 Participants
Phase 1: Cerdulatinib 40 mg QDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE1 Participants
Phase 1: Cerdulatinib 40 mg QDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE3 Participants
Phase 1: Cerdulatinib 20 mg BIDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE0 Participants
Phase 1: Cerdulatinib 20 mg BIDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE3 Participants
Phase 1: Cerdulatinib 50 mg QDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE4 Participants
Phase 1: Cerdulatinib 50 mg QDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE2 Participants
Phase 1: Cerdulatinib 65 mg QDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE6 Participants
Phase 1: Cerdulatinib 65 mg QDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE2 Participants
Phase 1: Cerdulatinib 100 mg QDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE3 Participants
Phase 1: Cerdulatinib 100 mg QDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE2 Participants
Phase 1: Cerdulatinib 45 mg BIDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE5 Participants
Phase 1: Cerdulatinib 45 mg BIDPhase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE3 Participants
Phase 2a: Cerdulatinib (FL Cohort)Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE42 Participants
Phase 2a: Cerdulatinib (FL Cohort)Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE22 Participants
Phase 2a: Cerdulatinib (MZL/WM Cohort)Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE2 Participants
Phase 2a: Cerdulatinib (MZL/WM Cohort)Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE12 Participants
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE7 Participants
Phase 2a: Cerdulatinib Plus Rituximab (FL Cohort)Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE26 Participants
Phase 2a: Cerdulatinib (aNHL Cohort)Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE6 Participants
Phase 2a: Cerdulatinib (aNHL Cohort)Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE3 Participants
Phase 2a: Cerdulatinib (CLL/SLL Cohort)Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE28 Participants
Phase 2a: Cerdulatinib (CLL/SLL Cohort)Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE17 Participants
Phase 2a: Cerdulatinib (PTCL Cohort)Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE65 Participants
Phase 2a: Cerdulatinib (PTCL Cohort)Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE42 Participants
Phase 2a: Cerdulatinib (CTCL Cohort)Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)AE41 Participants
Phase 2a: Cerdulatinib (CTCL Cohort)Phase 1 and Phase 2: Number of Participants With an Adverse Event (AE) or a Serious Adverse Event (SAE)SAE21 Participants
Secondary

Phase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of Cerdulatinib

Time frame: Cycle (C)1 Day (D)1: predose (0), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, and 72 hours postdose (except 15mg QD); C1D1: 0, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose (15mg QD); C2D1: 0, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose (all doses)

Population: The Pharmacokinetic Analysis Population consisted of all participants who received the requisite treatments and have data at the required timepoints. Only data from participants in Phase 1 cohorts (arms) were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at specified timepoints.

ArmMeasureGroupValue (MEAN)Dispersion
Phase 1: Cerdulatinib 15 mg QDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 21321 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 140.21
Phase 1: Cerdulatinib 15 mg QDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 1709.6 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 37.823
Phase 1: Cerdulatinib 30 mg QDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 21900 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 918.79
Phase 1: Cerdulatinib 30 mg QDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 11040 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 347.34
Phase 1: Cerdulatinib 45 mg QDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 26804 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 3065.6
Phase 1: Cerdulatinib 45 mg QDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 11826 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 713.67
Phase 1: Cerdulatinib 15 mg BIDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 1601.4 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 118.04
Phase 1: Cerdulatinib 15 mg BIDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 22129 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 533.14
Phase 1: Cerdulatinib 40 mg QDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 26313 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 166.81
Phase 1: Cerdulatinib 40 mg QDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 12064 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 666.52
Phase 1: Cerdulatinib 20 mg BIDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 1674.5 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 113.34
Phase 1: Cerdulatinib 20 mg BIDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 22779 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 458.94
Phase 1: Cerdulatinib 50 mg QDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 25871 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 3685.1
Phase 1: Cerdulatinib 50 mg QDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 12465 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 305.7
Phase 1: Cerdulatinib 65 mg QDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 26215 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 249.64
Phase 1: Cerdulatinib 65 mg QDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 12719 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 1208.2
Phase 1: Cerdulatinib 100 mg QDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 12758 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 969.37
Phase 1: Cerdulatinib 45 mg BIDPhase 1: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC0-12) of CerdulatinibDay 1 of Cycle 11335 hours*nanograms/milliliter (h*ng/mL)Standard Deviation 530.56
Secondary

Phase 1: Number of Participants Achieving Clinical Benefit

Clinical benefit was defined as achieving stable disease (SD) or better, as assessed by the Investigator. SD included: -Via a PET/CT scan, a score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with no significant change in FDG uptake from baseline at interim or end of treatment; no new lesions; and no change from baseline in bone marrow. -Via CT scan, \<50% decrease from baseline in sum of products of the greatest perpendicular diameters (SPD) of up to 6 dominant, measurable nodes and extranodal sites; no increase consistent with progression in nonmeasured lesions or organ enlargement; and no new lesions.

Time frame: Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 21 days or 28 days])

Population: The Safety Analysis Population included participants who received at least 1 dose of study drug. Only data from participants in Phase 1 cohorts (arms) were applicable and evaluated for this Outcome Measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 1: Cerdulatinib 15 mg QDPhase 1: Number of Participants Achieving Clinical Benefit2 Participants
Phase 1: Cerdulatinib 30 mg QDPhase 1: Number of Participants Achieving Clinical Benefit4 Participants
Phase 1: Cerdulatinib 45 mg QDPhase 1: Number of Participants Achieving Clinical Benefit4 Participants
Phase 1: Cerdulatinib 15 mg BIDPhase 1: Number of Participants Achieving Clinical Benefit1 Participants
Phase 1: Cerdulatinib 40 mg QDPhase 1: Number of Participants Achieving Clinical Benefit1 Participants
Phase 1: Cerdulatinib 20 mg BIDPhase 1: Number of Participants Achieving Clinical Benefit0 Participants
Phase 1: Cerdulatinib 50 mg QDPhase 1: Number of Participants Achieving Clinical Benefit2 Participants
Phase 1: Cerdulatinib 65 mg QDPhase 1: Number of Participants Achieving Clinical Benefit2 Participants
Phase 1: Cerdulatinib 100 mg QDPhase 1: Number of Participants Achieving Clinical Benefit1 Participants
Phase 1: Cerdulatinib 45 mg BIDPhase 1: Number of Participants Achieving Clinical Benefit1 Participants
Secondary

Phase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator

CR included: -Via a PET/CT scan, score of 1 (no uptake above background), 2 (uptake of \<mediastinum), or 3 (uptake of \>mediastinum but \<liver) for lymph nodes and extralymphatic sites; no new lesions; and no evidence of FDG-avid disease in bone marrow. -Via CT scan, target nodes/nodal masses regressed to \<1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement has regressed to normal; and bone marrow was normal by morphology and if indeterminate, immunohistochemistry was negative. PR included: -Via a PET/CT scan, a score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with baseline and residual masses of any size. -Via CT scan, \>50% decrease in the sum of the product of perpendicular diameters for multiple lesion of up to 6 target measurable nodes and extranodal sites.

Time frame: Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 21 days or 28 days])

Population: The Safety Analysis Population included participants who received at least 1 dose of study drug. Only data from participants in Phase 1 cohorts (arms) were applicable and evaluated for this Outcome Measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 1: Cerdulatinib 15 mg QDPhase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator0 Participants
Phase 1: Cerdulatinib 30 mg QDPhase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator1 Participants
Phase 1: Cerdulatinib 45 mg QDPhase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator1 Participants
Phase 1: Cerdulatinib 15 mg BIDPhase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator0 Participants
Phase 1: Cerdulatinib 40 mg QDPhase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator0 Participants
Phase 1: Cerdulatinib 20 mg BIDPhase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator0 Participants
Phase 1: Cerdulatinib 50 mg QDPhase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator0 Participants
Phase 1: Cerdulatinib 65 mg QDPhase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator1 Participants
Phase 1: Cerdulatinib 100 mg QDPhase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator0 Participants
Phase 1: Cerdulatinib 45 mg BIDPhase 1: Number of Participants Achieving Overall Response Rate (Partial Response [PR] Plus Complete Response [CR]) as Assessed by the Investigator2 Participants
Secondary

Phase 2a: Median Time to Progression-Free Survival (PFS)

PFS=(first documentation of disease progression \[DP\] or death \[whichever occurred first\]-study drug first dose date+1)/30.4375 in months. PFS right censored for 1 of these conditions: 1) no baseline disease assessments; 2) starting new anticancer therapy before documented DP/death; 3) DP/death immediately after \>6 months since last disease assessment (or \>12 months if after last cycle); & alive without documented DP. 95% confidence interval estimated using Brookmeyer method. DP included: -Via a PET/CT scan, score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with uptake increase in intensity, new FDG-avid foci, & no nonmeasured lesions. -Via CT, abnormal individual node/lesion with significant LDi or shortest axis perpendicular to LDi increase; prior splenomegaly, \>50% splenic length increase; if no prior splenomegaly, ≥2 cm splenic length increase; new or recurrent splenomegaly; new/clear progression of preexisting nonmeasured lesions.

Time frame: Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])

Population: The Efficacy Analysis Population included all participants who took at least 1 dose of study drug and had at least 1 post-baseline Investigator response assessment. Only the cohorts (arms) with participants with FL or with PTCL were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure.

ArmMeasureValue (MEDIAN)
Phase 1: Cerdulatinib 15 mg QDPhase 2a: Median Time to Progression-Free Survival (PFS)12.68 months
Phase 1: Cerdulatinib 30 mg QDPhase 2a: Median Time to Progression-Free Survival (PFS)3.61 months
Phase 1: Cerdulatinib 45 mg QDPhase 2a: Median Time to Progression-Free Survival (PFS)18.33 months
Phase 1: Cerdulatinib 15 mg BIDPhase 2a: Median Time to Progression-Free Survival (PFS)NA months
Phase 1: Cerdulatinib 40 mg QDPhase 2a: Median Time to Progression-Free Survival (PFS)4.57 months
Phase 1: Cerdulatinib 20 mg BIDPhase 2a: Median Time to Progression-Free Survival (PFS)1.18 months
Phase 1: Cerdulatinib 50 mg QDPhase 2a: Median Time to Progression-Free Survival (PFS)3.45 months
Secondary

Phase 2a: Number of Participants Achieving Clinical Benefit

Clinical benefit was defined as achieving SD or better, as assessed by the Investigator. SD included: -Via a PET/CT scan, a score of 4 (uptake of moderately \>liver) or 5 (uptake markedly higher than liver and/or new lesions) with no significant change in FDG uptake from baseline at interim or end of treatment; no new lesions; and no change from baseline in bone marrow. -Via CT scan, \<50% decrease from baseline in sum of products of the greatest perpendicular diameters (SPD) of up to 6 dominant, measurable nodes and extranodal sites; no increase consistent with progression in nonmeasured lesions or organ enlargement; and no new lesions.

Time frame: Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])

Population: The Efficacy Analysis Population included all participants who took at least 1 dose of study drug and had at least 1 post-baseline Investigator response assessment. Only the cohorts (arms) with participants with FL or with PTCL were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 1: Cerdulatinib 15 mg QDPhase 2a: Number of Participants Achieving Clinical Benefit19 Participants
Phase 1: Cerdulatinib 30 mg QDPhase 2a: Number of Participants Achieving Clinical Benefit8 Participants
Phase 1: Cerdulatinib 45 mg QDPhase 2a: Number of Participants Achieving Clinical Benefit16 Participants
Phase 1: Cerdulatinib 15 mg BIDPhase 2a: Number of Participants Achieving Clinical Benefit10 Participants
Phase 1: Cerdulatinib 40 mg QDPhase 2a: Number of Participants Achieving Clinical Benefit17 Participants
Phase 1: Cerdulatinib 20 mg BIDPhase 2a: Number of Participants Achieving Clinical Benefit2 Participants
Phase 1: Cerdulatinib 50 mg QDPhase 2a: Number of Participants Achieving Clinical Benefit16 Participants
Secondary

Phase 2a: Number of Participants Achieving Dominant Mass Response (DMR)

DMR was defined as achieving a ≥50% decrease from baseline in the SPD of the target nodal and extranodal lesions. SPD at a visit was considered missing if any target lesion was not evaluated.

Time frame: Baseline up to End of Treatment (up to last day of Cycle 10 [cycle = 28 days])

Population: The Efficacy Analysis Population included all participants who took at least 1 dose of study drug and had at least 1 post-baseline Investigator response assessment. Only the cohorts (arms) with participants with FL or with PTCL were applicable and evaluated for this Outcome Measure. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 1: Cerdulatinib 15 mg QDPhase 2a: Number of Participants Achieving Dominant Mass Response (DMR)14 Participants
Phase 1: Cerdulatinib 30 mg QDPhase 2a: Number of Participants Achieving Dominant Mass Response (DMR)5 Participants
Phase 1: Cerdulatinib 45 mg QDPhase 2a: Number of Participants Achieving Dominant Mass Response (DMR)14 Participants
Phase 1: Cerdulatinib 15 mg BIDPhase 2a: Number of Participants Achieving Dominant Mass Response (DMR)7 Participants
Phase 1: Cerdulatinib 40 mg QDPhase 2a: Number of Participants Achieving Dominant Mass Response (DMR)15 Participants
Phase 1: Cerdulatinib 20 mg BIDPhase 2a: Number of Participants Achieving Dominant Mass Response (DMR)1 Participants
Phase 1: Cerdulatinib 50 mg QDPhase 2a: Number of Participants Achieving Dominant Mass Response (DMR)5 Participants

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026