Extension Study for Patients Previously Enrolled in Protocol UTX-TGR-304

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-ES

Enrollment

200

Registered

2017-03-10

Start date

2017-04-06

Completion date

Unknown

Last updated

2017-04-18

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: 19.1 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: TGR-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. and 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 / platelet count > 40,000; b. Total bilirubin 30 mL/min (as calculated by the Cockcroft-Gault formula) 3. ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range 100

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 prophylaxis is encouraged. 5. Woman who are pregnant or lactating.

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Evaluations are to be obtained following the completions of cycles 3, 6, 9 12, 15, 18 and every 3 cycles. A cycle being 28 days. Patients who discontinue from study treatment (either for toxicity or physician choice) and have not progressed will continue to be followed for progression.as per the institutional standard of care or until a new anti-cancer treatment is initiated.;Main Objective: For patients previously on Arms B, C, & D of Study UTX-TGR-304: Primary Objective • 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: Primary Objective • 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: Secondary Objective • To evaluate the progression-free survival (PFS) and duration of response (DOR) • To evaluate the % of patients that achieve MRD negativity • To evaluate the safety of ublituximab in combination with TGR-1202 For patients previously on Arm A of Study UTX-TGR-304: Secondary Objective • To evaluate the safety of ublituximab in combination with TGR-1202;Primary end point(s): 1) Overall response rate (ORR). ORR is defined as sum of CR and PR rates. 2) Complete Response (CR) Rate. CR rate is defined as the proportion of patients who achieve a CR. 3) 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. 4) Minimal Residual Disease (MRD) Negativity Rate.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Evaluations are to be obtained following the completions of cycles 3, 6, 9 12, 15, 18 and every 3 cycles. A cycle being 28 days. Patients who discontinue from study treatment (either for toxicity or physician choice) and have not progressed will continue to be followed for progression.as per the institutional standard of care or until a new anti-cancer treatment is initiated.;Main Objective: For patients previously on Arms B, C, & D of Study UTX-TGR-304: Primary Objective • 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: Primary Objective • 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: Secondary Objective • To evaluate the progression-free survival (PFS) and duration of response (DOR) • To evaluate the % of patients that achieve MRD negativity • To evaluate the safety of ublituximab in combination with TGR-1202 For patients previously on Arm A of Study UTX-TGR-304: Secondary Objective • To evaluate the safety of ublituximab in combination with TGR-1202;Primary end point(s): 1) Overall response rate (ORR). ORR is defined as sum of CR and PR rates. 2) Complete Response (CR) Rate. CR rate is defined as the proportion of patients who achieve a CR. 3) 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. 4) Minimal Residual Disease (MRD) Negativity Rate.

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Secondary

Measure	Time frame
Secondary end point(s): 1) Minimal Residual Disease (MRD) Negativity Rate. MRD negativity rate is defined as the proportion of patients who are MRD negative. 2) 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. 3) 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. 4) Safety evaluation;Timepoint(s) of evaluation of this end point: Evaluations are to be obtained following the completions of cycles 3, 6, 9 12, 15, 18 and every 3 cycles. A cycle being 28 days. Patients who discontinue from study treatment (either for toxicity or physician choice) and have not progressed will continue to be followed for progression as per the institutional standard of care or until a new anti-cancer treatment is initiated. Safety - All AEs will be reported and evaluated using National Cancer Institute’s Common Terminology Criteria (CTCAE) v4.0	—

Measure

Time frame

Secondary end point(s): 1) Minimal Residual Disease (MRD) Negativity Rate. MRD negativity rate is defined as the proportion of patients who are MRD negative. 2) 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. 3) 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. 4) Safety evaluation;Timepoint(s) of evaluation of this end point: Evaluations are to be obtained following the completions of cycles 3, 6, 9 12, 15, 18 and every 3 cycles. A cycle being 28 days. Patients who discontinue from study treatment (either for toxicity or physician choice) and have not progressed will continue to be followed for progression as per the institutional standard of care or until a new anti-cancer treatment is initiated. Safety - All AEs will be reported and evaluated using National Cancer Institute’s Common Terminology Criteria (CTCAE) v4.0

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Countries

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

Contacts

Public ContactPallav Shah

Cambridge Regulatory Services Ltd

pallavshah@cambreg.co.uk+441480465755

Outcome results

None listed

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