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

Sponsor

TG Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01647971

Collaborator

(none)

Enrollment

Locations

Arm

33.4

Actual Duration (Months)

4.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkins Lymphoma B-cell Lymphoma Waldenstrom's Macroglobulinemia Marginal Zone Lymphoma Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Primary Central Nervous System Lymphoma	Drug: Ublituximab	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 19, 2012

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 CLL or 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.	Drug: Ublituximab Ublituximab is a novel monoclonal antibody targeting CD20

Arm

Intervention/Treatment

Experimental: 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 CLL or 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.

Drug: Ublituximab

Ublituximab is a novel monoclonal antibody targeting CD20

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Efficacy [Participants will be evaluated approximately every 8 - 12 weeks]
Efficacy will include overall response rate, duration of response and progression-free survival

Other Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TG Therapeutics Investigational Trial Site	Huntsville	Alabama	United States	35805
2	TG Therapeutics Investigational Trial Site	Jonesboro	Arkansas	United States	72401
3	TG Therapeutics Investigational Trial Site	Athens	Georgia	United States	30607
4	TG Therapeutics Investigational Trial Site	Macon	Georgia	United States	31201
5	TG Therapeutics Investigational Trial Site	Bethesda	Maryland	United States	20817
6	TG Therapeutics Investigational Trial Site	Morristown	New Jersey	United States	07962
7	TG Therapeutics Investigational Trial Site	New York	New York	United States	10022
8	TG Therapeutics Investigational Trial Site	Memphis	Tennessee	United States	38120