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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01647971

Enrollment

Registered

2012-07-24

Start date

2012-07-19

Completion date

2015-05-31

Last updated

2022-11-21

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

Conditions

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

Keywords

Lymphoma, Rituxan, Relapsed, Refractory

Brief summary

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.

Interventions

DRUGUblituximab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Subjects will be followed for 4 weeks	Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation
Maximum Tolerated Dose acceptable for participants	Subjects will be followed for 4 weeks	The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board

Secondary

Measure	Time frame	Description
Efficacy	Participants will be evaluated approximately every 8 - 12 weeks	Efficacy will include overall response rate, duration of response and progression-free survival

Other

Measure	Time frame
Pharmacokinetic profile including Peak Plasma Concentration (Cmax) or Area Pharmacokinetic profile including Peak Plasma Concentration (Cmax) and Area under the plasma concentration versus time curve (AUC)	Up to 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026