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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01647971
First received: July 17, 2012
Last updated: January 25, 2014
Last verified: January 2014
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by TG Therapeutics, Inc.:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Subjects will be followed for 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Subjects will be followed for 4 weeks ] [ Designated as safety issue: No ]
    The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board


Secondary Outcome Measures:
  • Efficacy [ Time Frame: Participants will be evaluated approximately every 8 - 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647971

Locations
United States, Alabama
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States, 35805
United States, Arkansas
TG Therapeutics Investigational Trial Site
Jonesboro, Arkansas, United States, 72401
United States, Georgia
TG Therapeutics Investigational Trial Site
Athens, Georgia, United States, 30607
TG Therapeutics Investigational Trial Site
Macon, Georgia, United States, 31201
United States, Maryland
TG Therapeutics Investigational Trial Site
Bethesda, Maryland, United States, 20817
United States, New Jersey
TG Therapeutics Investigational Trial Site
Morristown, New Jersey, United States, 07962
United States, New York
TG Therapeutics Investigational Trial Site
New York, New York, United States, 10022
United States, Tennessee
TG Therapeutics Investigational Trial Site
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
Study Director: TG Therapeutics Clinical Trials TG Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01647971     History of Changes
Other Study ID Numbers: TGTX 1101-101
Study First Received: July 17, 2012
Last Updated: January 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by TG Therapeutics, Inc.:
Lymphoma
Rituxan
Relapsed
Refractory

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Waldenstrom Macroglobulinemia
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on August 20, 2014