Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-19

Study Completion Date

2015-05-31

Brief Summary

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The purpose of this study is to determine whether ublituximab is safe and effective in patients with relapsed or refractory B-cell lymphoma who were previously treated with rituximab.

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Detailed Description

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Conditions

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Non-Hodgkins Lymphoma B-cell Lymphoma Waldenstrom's Macroglobulinemia Marginal Zone Lymphoma Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL) Primary Central Nervous System Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ublituximab

Phase I:

4 cohorts with IV ublituximab starting with 450 mg followed by 600 mg, 900 mg or 1200 mg in each cohort (3 - 6 patients per cohort). Infusions will be on days 1, 8, 15 and 22 of cycle 1 followed by a planned maintenance with a single infusion monthly starting cycle 3. Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) will have infusions on Days 1, 8 and 15 of cycle 1 \& 2 followed by a planned maintenance with a single infusion monthly starting cycle 3. Expansion of patient enrollment in select cohorts will apply.

Group Type EXPERIMENTAL

Ublituximab

Intervention Type DRUG

Ublituximab is a novel monoclonal antibody targeting cluster of differentiate 20 (CD20)

Interventions

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Ublituximab

Ublituximab is a novel monoclonal antibody targeting cluster of differentiate 20 (CD20)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Relapsed or Refractory B-cell Lymphoma
* Measurable or Evaluable Disease
* Previously treated with at least one line of rituximab or a rituximab based therapy
* Patients ineligible for high dose or combination chemotherapy + stem cell transplant
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* No active or chronic infection of Hepatitis B or C and no history of HIV based on negative serology

Exclusion Criteria

* Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry
* Prior autologous or allogeneic stem cell transplantation within 3 months of study entry
* History of severe hypersensitivity or anaphylaxis to prior rituximab
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, brain metastasis, or psychiatric illness that would limit compliance with study requirements
* Pregnant women

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No