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A Study for Patients With Non-Hodgkin's Lymphomas

A Multicenter, Open-label, Noncomparative Study of Enzastaurin in Patients With Non-Hodgkin's Lymphomas

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00542919
Enrollment
57
Registered
2007-10-12
Start date
2007-11-30
Completion date
2018-02-27
Last updated
2020-10-19

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

Conditions

B-Cell Lymphoma, T-Cell Lymphoma

Brief summary

In this study, all patients will get investigational drug. There will be no comparator drug. This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes: * T-cell lymphoma: Peripheral and Cutaneous T-cell lymphoma (PTCL, CTCL) * Indolent B-cell lymphoma: Small lymphocytic lymphoma, follicular lymphoma (Gr 1 or 2) and marginal zone lymphoma * Aggressive B-cell lymphoma: Primary CNS lymphoma, follicular lymphoma (Gr 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma.

Interventions

DRUGenzastaurin

1125 mg loading dose then 500 mg, oral, daily until progressive disease

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* Have measurable lesions * Have recovered from prior chemotherapies * Have an estimated life expectancy of at least 12 weeks * Hepatic: total bilirubin less than or equal to 1.5 XULN; ATL/AST less than or equal to 2.0 x ULN (less than 5x if liver metastases are present) * Renal: serum creatinine less than or equal to 1.5XULN * Adequate bone marrow reserve: platelets greater than or equal to 75 x 109 /Liter (L) Criteria: * Have a second primary malignancy (except adequately treated nonmelanomatous skin cancer, or other cancer that is considered cured by surgical resection or radiation). * Anti-lymphoma therapy within the past 3 weeks * Unable to swallow tablets * Unable to discontinue use of carbamazepine, phenobarbital and phenytoin at least 14 days prior to study enrollment

Design outcomes

Primary

MeasureTime frameDescription
Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Baseline to Measured Progressive Disease (Up to 114 Months)Tumor RR is defined as the number of responders divided by the number of treated participants for that tumor subtype. A responder was a participant who exhibited: a CR defined as a modified severity-weighted assessment tool (mSWAT) value of zero or a partial response (PR) defined as a mSWAT value \> 50% decrease from baseline \[for participants with cutaneous T-cell lymphoma (CTCL) using the mSWAT or CR, unconfirmed CR (Cru), or PR as defined by Abrey et al., (2005) (for participants with central nervous system (CNS) Lymphoma); or for all other participants a CR or complete response - unconfirmed (CRu) or PR as defined by Cheson et al., (1999).

Secondary

MeasureTime frameDescription
Progression Free Survival (PFS)Baseline to Measured Progressive Disease or Death From Any Cause (Up to 114 Months)Progression-free survival is defined as the time from the date of study enrollment to the first date of objectively determined progressive disease or death from any cause. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment.
Time to Progressive (TTP) DiseaseBaseline to Measured Progressive Disease (Up to 114 Months)TTP disease is defined as the time from the date of study enrollment to the date of objectively determined disease progression. Objectively determined progressive disease (PD) was interpreted as meeting the criteria for PD. For patients who died without documented objective PD (including death from study disease); TTP was censored at the date of the last objective progression-free disease assessment prior to death. For participants not known to have died as of the data cut-off date and who did not have objective PD, TTP was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, TTP was censored at the date of the last objective progression free disease assessment prior to post-discontinuation therapy.
Duration of Response (DOR)Baseline to Measured Progressive Disease (Up to 97 Months)DoR is defined as the time from the date when the measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the date of first observation of objectively determined disease progression (CR, CRu, or PR see above definition of responder). For responding participants who died without PD (including death from study disease), DoR was censored at the last assessment demonstrating lack of progression. For responding patients not known to have died as of the data cut-off date and who did not have PD, DoR was censored at the last assessment demonstrating objective response prior to the data cut-off date. For responding participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression, DoR was censored at the last assessment demonstrating objective response prior to the initiation of post-discontinuation anticancer therapy.
Percentage of Participants With Progression Free Survival (PFS) at 1-YearBaseline to Measured Progressive Disease or Death From Any Cause (1 Year)PFS at 1 year was defined as the probability of being alive and having not progressed at 1 year and calculated from the PFS Kaplan-Meier analysis. PFS was censored at the date of the last objective progression-free assessment. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment.
Number of Participants With One or More Drug-Related Adverse EventsBaseline to End of Study (Up to 114 Months)Number of participants with one or more Drug-Related Adverse Events. Clinically significant events are defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.

Countries

Australia, Brazil, Mexico, Peru, United States

Participant flow

Pre-assignment details

Completers include participants who had progressive disease, died due to any cause or alive and on study at the end of study, but off treatment.

Participants by arm

ArmCount
T-Cell
T-Cell (TCL): Peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
23
Indolent B-Cell
Indolent B-Cell (IBCL): Small lymphocytic lymphoma, follicular lymphoma (Grade 1 or 2) and marginal zone lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
19
Aggressive B-Cell
Aggressive B-Cell (ABCL): Primary central nervous system (CNS) lymphoma, follicular lymphoma (Grade 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days.
15
Total57

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event151
Overall StudyLost to Follow-up201
Overall StudyPhysician Decision221
Overall StudySponsor Decision100
Overall StudyWithdrawal by Subject103

Baseline characteristics

CharacteristicT-CellIndolent B-CellAggressive B-CellTotal
Age, Continuous49.3 years
STANDARD_DEVIATION 17.54
69.7 years
STANDARD_DEVIATION 10.46
60.1 years
STANDARD_DEVIATION 8.44
58.9 years
STANDARD_DEVIATION 15.9
Ethnicity (NIH/OMB)
Hispanic or Latino
18 Participants8 Participants11 Participants37 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants11 Participants4 Participants20 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
12 Participants2 Participants2 Participants16 Participants
Race (NIH/OMB)
White
9 Participants17 Participants12 Participants38 Participants
Region of Enrollment
Argentina
0 Participants1 Participants2 Participants3 Participants
Region of Enrollment
Australia
1 Participants9 Participants2 Participants12 Participants
Region of Enrollment
Brazil
7 Participants2 Participants3 Participants12 Participants
Region of Enrollment
Mexico
9 Participants6 Participants7 Participants22 Participants
Region of Enrollment
Peru
5 Participants0 Participants0 Participants5 Participants
Region of Enrollment
United States
1 Participants1 Participants1 Participants3 Participants
Sex: Female, Male
Female
12 Participants5 Participants7 Participants24 Participants
Sex: Female, Male
Male
11 Participants14 Participants8 Participants33 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
19 / 2317 / 1910 / 15
serious
Total, serious adverse events
9 / 2311 / 195 / 15

Outcome results

Primary

Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])

Tumor RR is defined as the number of responders divided by the number of treated participants for that tumor subtype. A responder was a participant who exhibited: a CR defined as a modified severity-weighted assessment tool (mSWAT) value of zero or a partial response (PR) defined as a mSWAT value \> 50% decrease from baseline \[for participants with cutaneous T-cell lymphoma (CTCL) using the mSWAT or CR, unconfirmed CR (Cru), or PR as defined by Abrey et al., (2005) (for participants with central nervous system (CNS) Lymphoma); or for all other participants a CR or complete response - unconfirmed (CRu) or PR as defined by Cheson et al., (1999).

Time frame: Baseline to Measured Progressive Disease (Up to 114 Months)

Population: All participants with all tumor subtypes, who received at least one dose of study drug, and had evaluable tumor response rate data.

ArmMeasureGroupValue (NUMBER)
Peripheral T-cell Lymphoma (PTCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Unknown16.7 percentage of participants
Peripheral T-cell Lymphoma (PTCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])CRu0 percentage of participants
Peripheral T-cell Lymphoma (PTCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Stable Disease33.3 percentage of participants
Peripheral T-cell Lymphoma (PTCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])CR0 percentage of participants
Peripheral T-cell Lymphoma (PTCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])PR0 percentage of participants
Peripheral T-cell Lymphoma (PTCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Progressive Disease (PD)50.0 percentage of participants
Cutaneous T-cell Lymphoma (CTCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])CR0 percentage of participants
Cutaneous T-cell Lymphoma (CTCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Stable Disease36.4 percentage of participants
Cutaneous T-cell Lymphoma (CTCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Unknown9.1 percentage of participants
Cutaneous T-cell Lymphoma (CTCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])CRu9.1 percentage of participants
Cutaneous T-cell Lymphoma (CTCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Progressive Disease (PD)36.4 percentage of participants
Cutaneous T-cell Lymphoma (CTCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])PR9.1 percentage of participants
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Progressive Disease (PD)0 percentage of participants
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])PR14.3 percentage of participants
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Unknown0 percentage of participants
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Stable Disease85.7 percentage of participants
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])CR0 percentage of participants
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])CRu0 percentage of participants
Follicular Grade 1 & 2 (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Progressive Disease (PD)12.5 percentage of participants
Follicular Grade 1 & 2 (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])CR0 percentage of participants
Follicular Grade 1 & 2 (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])CRu0 percentage of participants
Follicular Grade 1 & 2 (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])PR12.5 percentage of participants
Follicular Grade 1 & 2 (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Stable Disease62.5 percentage of participants
Follicular Grade 1 & 2 (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Unknown12.5 percentage of participants
Marginal Zone Lymphoma (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Stable Disease100.0 percentage of participants
Marginal Zone Lymphoma (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])CRu0 percentage of participants
Marginal Zone Lymphoma (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Progressive Disease (PD)0 percentage of participants
Marginal Zone Lymphoma (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Unknown0 percentage of participants
Marginal Zone Lymphoma (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])PR0 percentage of participants
Marginal Zone Lymphoma (IBCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])CR0 percentage of participants
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])PR20.0 percentage of participants
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Stable Disease20.0 percentage of participants
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])CRu0 percentage of participants
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Progressive Disease (PD)40.0 percentage of participants
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])CR0 percentage of participants
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Unknown20.0 percentage of participants
History of IBCL (ABCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])PR0 percentage of participants
History of IBCL (ABCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])CRu0 percentage of participants
History of IBCL (ABCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Unknown10.0 percentage of participants
History of IBCL (ABCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Stable Disease50.0 percentage of participants
History of IBCL (ABCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])Progressive Disease (PD)30.0 percentage of participants
History of IBCL (ABCL)Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])CR10.0 percentage of participants
Secondary

Duration of Response (DOR)

DoR is defined as the time from the date when the measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the date of first observation of objectively determined disease progression (CR, CRu, or PR see above definition of responder). For responding participants who died without PD (including death from study disease), DoR was censored at the last assessment demonstrating lack of progression. For responding patients not known to have died as of the data cut-off date and who did not have PD, DoR was censored at the last assessment demonstrating objective response prior to the data cut-off date. For responding participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression, DoR was censored at the last assessment demonstrating objective response prior to the initiation of post-discontinuation anticancer therapy.

Time frame: Baseline to Measured Progressive Disease (Up to 97 Months)

Population: All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable DOR data.

ArmMeasureValue (MEDIAN)
Peripheral T-cell Lymphoma (PTCL)Duration of Response (DOR)0 Days
Cutaneous T-cell Lymphoma (CTCL)Duration of Response (DOR)394.0 Days
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)Duration of Response (DOR)281.0 Days
Follicular Grade 1 & 2 (IBCL)Duration of Response (DOR)1.0 Days
Marginal Zone Lymphoma (IBCL)Duration of Response (DOR)0 Days
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)Duration of Response (DOR)58.0 Days
History of IBCL (ABCL)Duration of Response (DOR)2957.0 Days
Secondary

Number of Participants With One or More Drug-Related Adverse Events

Number of participants with one or more Drug-Related Adverse Events. Clinically significant events are defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.

Time frame: Baseline to End of Study (Up to 114 Months)

Population: All participants who received at least one dose of study drug.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Peripheral T-cell Lymphoma (PTCL)Number of Participants With One or More Drug-Related Adverse Events2 Participants
Cutaneous T-cell Lymphoma (CTCL)Number of Participants With One or More Drug-Related Adverse Events3 Participants
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)Number of Participants With One or More Drug-Related Adverse Events0 Participants
Secondary

Percentage of Participants With Progression Free Survival (PFS) at 1-Year

PFS at 1 year was defined as the probability of being alive and having not progressed at 1 year and calculated from the PFS Kaplan-Meier analysis. PFS was censored at the date of the last objective progression-free assessment. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment.

Time frame: Baseline to Measured Progressive Disease or Death From Any Cause (1 Year)

Population: All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable 1-year rate PFS data.

ArmMeasureValue (NUMBER)
Peripheral T-cell Lymphoma (PTCL)Percentage of Participants With Progression Free Survival (PFS) at 1-Year0.0 percentage of participants
Cutaneous T-cell Lymphoma (CTCL)Percentage of Participants With Progression Free Survival (PFS) at 1-Year36.8 percentage of participants
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)Percentage of Participants With Progression Free Survival (PFS) at 1-Year14.3 percentage of participants
Follicular Grade 1 & 2 (IBCL)Percentage of Participants With Progression Free Survival (PFS) at 1-Year51.4 percentage of participants
Marginal Zone Lymphoma (IBCL)Percentage of Participants With Progression Free Survival (PFS) at 1-Year0.0 percentage of participants
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)Percentage of Participants With Progression Free Survival (PFS) at 1-Year25.0 percentage of participants
History of IBCL (ABCL)Percentage of Participants With Progression Free Survival (PFS) at 1-Year48.6 percentage of participants
Secondary

Progression Free Survival (PFS)

Progression-free survival is defined as the time from the date of study enrollment to the first date of objectively determined progressive disease or death from any cause. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment.

Time frame: Baseline to Measured Progressive Disease or Death From Any Cause (Up to 114 Months)

Population: All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable PFS data. Participants censored: 0 (PTCL), 3 (CTCL), 0 (small lymphocytic), 2 (follicular grade 1 \& 2), 0 (follicular grade 3a and 4b), 0 (marginal zone) and 4 (history of IBCL)

ArmMeasureValue (MEDIAN)
Peripheral T-cell Lymphoma (PTCL)Progression Free Survival (PFS)58 Days
Cutaneous T-cell Lymphoma (CTCL)Progression Free Survival (PFS)227 Days
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)Progression Free Survival (PFS)303 Days
Follicular Grade 1 & 2 (IBCL)Progression Free Survival (PFS)429 Days
Marginal Zone Lymphoma (IBCL)Progression Free Survival (PFS)159 Days
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)Progression Free Survival (PFS)114 Days
History of IBCL (ABCL)Progression Free Survival (PFS)68 Days
Secondary

Time to Progressive (TTP) Disease

TTP disease is defined as the time from the date of study enrollment to the date of objectively determined disease progression. Objectively determined progressive disease (PD) was interpreted as meeting the criteria for PD. For patients who died without documented objective PD (including death from study disease); TTP was censored at the date of the last objective progression-free disease assessment prior to death. For participants not known to have died as of the data cut-off date and who did not have objective PD, TTP was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, TTP was censored at the date of the last objective progression free disease assessment prior to post-discontinuation therapy.

Time frame: Baseline to Measured Progressive Disease (Up to 114 Months)

Population: All participants with all tumor subtypes, who received at least one dose of study drug and had evaluable TTP data. Participants censored: 0 (PTCL), 3 (CTCL), 0 (small lymphocytic), 2 (follicular grade 1 \& 2), 0 (follicular grade 3a and 4b), 0 (marginal zone) and 4 (history of IBCL)

ArmMeasureValue (MEDIAN)
Peripheral T-cell Lymphoma (PTCL)Time to Progressive (TTP) Disease58 Days
Cutaneous T-cell Lymphoma (CTCL)Time to Progressive (TTP) Disease227 Days
Small Lymphocytic Indolent B-Cell Lymphoma (IBCL)Time to Progressive (TTP) Disease308 Days
Follicular Grade 1 & 2 (IBCL)Time to Progressive (TTP) Disease429 Days
Marginal Zone Lymphoma (IBCL)Time to Progressive (TTP) Disease159 Days
Follicular Grade 3a & 3b Aggressive B-cell Lymphoma (ABCL)Time to Progressive (TTP) Disease114 Days
History of IBCL (ABCL)Time to Progressive (TTP) Disease68 Days

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026