A Multi-Center, Open-Label, Extension Study of Ublituximab (TG-1101) in Combination with TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004339-19-GB

Enrollment

242

Registered

2018-05-08

Start date

2017-05-09

Completion date

Unknown

Last updated

2018-05-14

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

Conditions

Chronic Lymphocytic Leukemia MedDRA version: 20.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 100000004864

Interventions

Product Name: Ublituximab Product Code: TG-1101 Pharmaceutical Form: Solution for injection INN or Proposed INN: UBLITUXIMAB Current Sponsor code: TG-1101 Other descriptive name: IgG1 immunoglobulins

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Prior treatment in clinical trial UTX-TGR-304 a. Confirmed progression by IRC from either Arms B, C, or D after at least two cycles of treatment in trial UTX-TGR-304 b. Non-progressing patients from Arm A may be eligible for enrollment when protocol UTX-TGR-304 is completed 2. Adequate organ system function, defined as follows: a. Absolute neutrophil count (ANC) > 750 X 1000 /mm3 (0.75 K/uL) mL of blood/ platelet count > 40 X 1000/mm3 (40 K/uL) mL of blood b. Total bilirubin =1.5 times the upper limit of normal (ULN) c. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 x ULN if no liver involvement or =5 x the ULN if known liver involvement d. Calculated creatinine clearance >30 mL/min (as calculated by the Cockcroft-Gault formula) 3. ECOG performance status = 2 4. Ability to swallow and retain oral medication 5. Willingness and ability to comply with trial and follow-up procedures, give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: 1. Prior treatment with obinutuzumab + chlorambucil (Arm B patients) or ublituximab (Arm C patients) within 7 days of Cycle 1/Day 1. 2. Patients refractory to (progressing on) UTX-TGR-304 Treatment Arm A (ublituximab + TGR-1202). 3. Known histological transformation from CLL to an aggressive lymphoma (i.e. Richter’s transformation). 4. Evidence of ongoing systemic bacterial, fungal or viral infection, except localized fungal infections of skin or nails. NOTE: Patients may be receiving prophylactic antiviral or antibacterial therapies at investigator discretion. Use of anti-pneumocystis pneumonia prophylaxis is encouraged. 5. Woman who are pregnant or lactating. 6. Live virus vaccines four (4) weeks prior to or during ublituximab therapy.

Design outcomes

Primary

Measure	Time frame
Main Objective: For patients previously on Arms B, C, & D of Study UTX-TGR-304: To determine the overall response rate (ORR) defined as the sum of complete responses (CR) and partial responses (PR) For patients previously on Arm A of Study UTX-TGR-304: To evaluate the progression-free survival (PFS) and duration of response (DOR);Secondary Objective: For patients previously on Arms B, C, & D of Study UTX-TGR-304: To evaluate the progression-free survival (PFS) and duration of response (DOR) To evaluate the % of patients that achieve MRD negativity For patients previously on Arm A of Study UTX-TGR-304: To evaluate the safety of ublituximab in combination with TGR-1202 ;Primary end point(s): For patients previously on Arms B, C, & D of Study UTX-TGR-304: Overall response rate (ORR) ORR is defined as sum of CR and PR rates. Complete Response (CR) Rate CR rate is defined as the proportion of patients who achieve a CR. For patients previously on Arm A of Study UTX-TGR-304: Progression-free survival (PFS) PFS is defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression based on standard criteria (Hallek et al. 2008) and occurring for any reason (i.e., increasing lymphadenopathy, organomegaly or bone marrow involvement; decreasing platelet count, hemoglobin, or neutrophil count; or worsening of disease-related symptoms) other than lymphocytosis. Duration of response (DOR) DOR is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause.;Timepoint(s) of evaluation of this end point: During the study period, all patients will be evaluated for response by CT and/or MRI. Evaluations are to be obtained following the completions of cycles 3, 6, 9 12, 15, 18 and every 3 cycles thereafter. All efficacy assessments have a +/- 7 day window. The determination of r	—

Measure

Time frame

Main Objective: For patients previously on Arms B, C, & D of Study UTX-TGR-304: To determine the overall response rate (ORR) defined as the sum of complete responses (CR) and partial responses (PR) For patients previously on Arm A of Study UTX-TGR-304: To evaluate the progression-free survival (PFS) and duration of response (DOR);Secondary Objective: For patients previously on Arms B, C, & D of Study UTX-TGR-304: To evaluate the progression-free survival (PFS) and duration of response (DOR) To evaluate the % of patients that achieve MRD negativity For patients previously on Arm A of Study UTX-TGR-304: To evaluate the safety of ublituximab in combination with TGR-1202 ;Primary end point(s): For patients previously on Arms B, C, & D of Study UTX-TGR-304: Overall response rate (ORR) ORR is defined as sum of CR and PR rates. Complete Response (CR) Rate CR rate is defined as the proportion of patients who achieve a CR. For patients previously on Arm A of Study UTX-TGR-304: Progression-free survival (PFS) PFS is defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression based on standard criteria (Hallek et al. 2008) and occurring for any reason (i.e., increasing lymphadenopathy, organomegaly or bone marrow involvement; decreasing platelet count, hemoglobin, or neutrophil count; or worsening of disease-related symptoms) other than lymphocytosis. Duration of response (DOR) DOR is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause.;Timepoint(s) of evaluation of this end point: During the study period, all patients will be evaluated for response by CT and/or MRI. Evaluations are to be obtained following the completions of cycles 3, 6, 9 12, 15, 18 and every 3 cycles thereafter. All efficacy assessments have a +/- 7 day window. The determination of r

—

Secondary

Measure	Time frame
Secondary end point(s): For patients previously on Arms B, C, & D of Study UTX-TGR-304: Progression-free survival (PFS) PFS is defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression or death from any cause. Duration of response (DOR) Definitive disease progression based on standard criteria (Hallek et al. 2008) and occurring for any reason (i.e., increasing lymphadenopathy, organomegaly or bone marrow involvement; decreasing platelet count, hemoglobin, or neutrophil count; or worsening of disease-related symptoms) other than lymphocytosis. DOR is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause. Minimal Residual Disease (MRD) Negativity Rate MRD negativity rate is defined as the proportion of patients who are MRD negative. For patients previously on Arm A of Study UTX-TGR-304: Safety All Adverse Events (AE's) will be reported and evaluated using National Cancer Institute's Common Terminology Criteria (CTCAE) v4.0.;Timepoint(s) of evaluation of this end point: During the study period, all patients will be evaluated for response by CT and/or MRI. Evaluations are to be obtained following the completions of cycles 3, 6, 9 12, 15, 18 and every 3 cycles thereafter. All efficacy assessments have a +/- 7 day window. The determination of response and progression will be based on IWCLL criteria (Hallek M, 2008) by the treating investigator. Scans may be collected and confirmed by central independent radiology group in select cases.	—

Measure

Time frame

Secondary end point(s): For patients previously on Arms B, C, & D of Study UTX-TGR-304: Progression-free survival (PFS) PFS is defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression or death from any cause. Duration of response (DOR) Definitive disease progression based on standard criteria (Hallek et al. 2008) and occurring for any reason (i.e., increasing lymphadenopathy, organomegaly or bone marrow involvement; decreasing platelet count, hemoglobin, or neutrophil count; or worsening of disease-related symptoms) other than lymphocytosis. DOR is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause. Minimal Residual Disease (MRD) Negativity Rate MRD negativity rate is defined as the proportion of patients who are MRD negative. For patients previously on Arm A of Study UTX-TGR-304: Safety All Adverse Events (AE's) will be reported and evaluated using National Cancer Institute's Common Terminology Criteria (CTCAE) v4.0.;Timepoint(s) of evaluation of this end point: During the study period, all patients will be evaluated for response by CT and/or MRI. Evaluations are to be obtained following the completions of cycles 3, 6, 9 12, 15, 18 and every 3 cycles thereafter. All efficacy assessments have a +/- 7 day window. The determination of response and progression will be based on IWCLL criteria (Hallek M, 2008) by the treating investigator. Scans may be collected and confirmed by central independent radiology group in select cases.

—

Countries

Czech Republic, Italy, Poland, Spain, United Kingdom, United States

Contacts

Public ContactPallav Shah

Cambridge Regulatory Services

pallavshah@cambreg.co.uk+441480465755

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026