Trial | NCT01647971  Report issue

Title

Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
An Open Label Phase I/II Study of the Efficacy and Safety of Ublituximab in Patients With B-cell Non-Hodgkin Lymphoma Who Have Relapsed or Are Refractory After CD20 Directed Antibody Therapy

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    39
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.
Study Started
Jul 19
2012
Primary Completion
May 31
2015
Study Completion
May 31
2015
Last Update
Nov 21
2022

Drug Ublituximab

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

ublituximab Experimental

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.

Criteria 

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
No Results Posted