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

Primary Purpose

Non-Hodgkins Lymphoma, B-cell Lymphoma, Waldenstrom's Macroglobulinemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ublituximab
Sponsored by
TG Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkins Lymphoma focused on measuring Lymphoma, Rituxan, Relapsed, Refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ublituximab

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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
The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board

Secondary Outcome Measures

Efficacy
Efficacy will include overall response rate, duration of response and progression-free survival

Full Information

First Posted
July 17, 2012
Last Updated
November 16, 2022
Sponsor
TG Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01647971
Brief Title
Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 19, 2012 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Lymphoma, Rituxan, Relapsed, Refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ublituximab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ublituximab
Intervention Description
Ublituximab is a novel monoclonal antibody targeting cluster of differentiate 20 (CD20)
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation
Time Frame
Subjects will be followed for 4 weeks
Title
Maximum Tolerated Dose acceptable for participants
Description
The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board
Time Frame
Subjects will be followed for 4 weeks
Secondary Outcome Measure Information:
Title
Efficacy
Description
Efficacy will include overall response rate, duration of response and progression-free survival
Time Frame
Participants will be evaluated approximately every 8 - 12 weeks
Other Pre-specified Outcome Measures:
Title
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)
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TG Therapeutics Clinical Trials
Organizational Affiliation
TG Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
TG Therapeutics Investigational Trial Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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