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Trial record 34 of 42 for:    LENALIDOMIDE AND Leukemia AND SLL

Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01744912
Recruitment Status : Completed
First Posted : December 7, 2012
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 5, 2012
First Posted Date  ICMJE December 7, 2012
Last Update Posted Date October 13, 2014
Study Start Date  ICMJE December 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
Maximum Tolerated Dose acceptable for participants [ Time Frame: 4 weeks ]
The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01744912 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2013)
Efficacy [ Time Frame: After 8 weeks and then every 12 weeks ]
Efficacy will include overall response rate and duration of response
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
Efficacy [ Time Frame: 12 weeks ]
Efficacy will include overall response rate and duration of response
Current Other Pre-specified Outcome Measures
 (submitted: December 5, 2012)
Pharmacokinetic profile including Peak Plasma Concentration (Cmax) [ Time Frame: Up to 6 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies
Official Title  ICMJE Phase I/II Study of Ublituximab in Combination With Lenalidomide (Revlimid®) in Patients With B-Cell Lymphoid Malignancies Who Have Relapsed or Are Refractory After CD20 Directed Antibody Therapy
Brief Summary The purpose of this study is to determine whether ublituximab in combination with lenalidomide (Revlimid®) is safe and effective in patients with B-Cell Lymphoid Malignancies who have relapsed or are refractory after CD20 directed antibody therapy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Hodgkins Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • B-cell Lymphomas
  • Marginal Zone Lymphoma
  • Mantle Cell Lymphoma
  • Waldenstrom's Macroglobulinemia
Intervention  ICMJE
  • Drug: Ublituximab
    Ublituximab is a novel monoclonal antibody targeting CD20
    Other Name: TG-1101
  • Drug: Lenalidomide
    Lenalidomide has both immunomodulatory and anti-angiogenic properties which could confer antitumor and antimetastatic effects
    Other Name: Revlimid
Study Arms  ICMJE Experimental: Ublituximab + Lenalidomide

4 cohorts, with 3 - 6 patients per cohort, as follows:

  • Cohort 1: Ublituximab 450 mg + Lenalidomide 10 mg
  • Cohort 2: Ublituximab 450 mg + Lenalidomide 15 mg
  • Cohort 3: Ublituximab 600 mg + Lenalidomide 10 mg (escalation to 15 mg permitted after cycle 1)
  • Cohort 4: Ublituximab 900 mg + Lenalidomide 10 mg (escalation to 15 mg permitted after cycle 1)

Ublituximab is an IV infusion on days 1, 8, and 15 of cycles 1 & 2 followed by a planned maintenance with a single infusion on day 1 of cycles 3 thru 6.

Lenalidomide is taken orally on days 9 - 28 of cycle 1 followed by daily administration on Days 1 - 28 for cycles 2 thru 6. Non-hodgkins lymphoma patients may have up to a 7 day rest period (Days 21-28) in any cycle.

Interventions:
  • Drug: Ublituximab
  • Drug: Lenalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2014)
10
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2012)
60
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Relapsed or refractory B-cell non-Hodgkins Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
  • Patients must have received at least one prior line of therapy with an anti-CD20 antibody (i.e. rituximab, ofatumumab, etc.) or an anti-CD20 antibody containing regimen
  • Measurable or evaluable Disease
  • Eastern Cooperative Oncology Group performance status 0, 1 or 2
  • Patients ineligible for high dose or combination chemotherapy + stem cell transplant
  • No active or chronic infection of Hepatitis B or C and no history of HIV based on negative serology
  • All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®

Exclusion Criteria:

  • Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry
  • Prior autologous or allogeneic stem cell transplantation within 6 months of study entry
  • History of severe hypersensitivity or anaphylaxis to prior murine or mouse/human chimeric antibodies, or to any component of ublituximab, or with prior lenalidomide or thalidomide
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
  • History of deep vein thrombosis (DVT) or pulmonary embolus (PE) in the six months prior to Day 1 of Cycle 1
  • Pregnant women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01744912
Other Study ID Numbers  ICMJE TGTX 1101-102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TG Therapeutics, Inc.
Study Sponsor  ICMJE TG Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: TG Therapeutics Clinical Trials TG Therapeutics, Inc.
PRS Account TG Therapeutics, Inc.
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP