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Trial record 1 of 5 for:    ibrutinib TG
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Ublituximab + Ibrutinib in Select B-cell Malignancies

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ClinicalTrials.gov Identifier: NCT02013128
Recruitment Status : Active, not recruiting
First Posted : December 17, 2013
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 11, 2013
First Posted Date  ICMJE December 17, 2013
Last Update Posted Date February 27, 2019
Study Start Date  ICMJE December 2013
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies [ Time Frame: 28 days (1 cycle of therapy) ]
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02013128 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
Overall Response Rate [ Time Frame: Up to 1 year ]
To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with Ibrutinib
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Ublituximab + Ibrutinib in Select B-cell Malignancies
Official Title  ICMJE A Multi-center Phase II Study With Safety Run-in Evaluating the Efficacy and Safety of Ublituximab in Combination With Ibrutinib in Patients With Select B-Cell Malignancies
Brief Summary The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Lymphocytic Leukemia
  • Mantle Cell Lymphoma
Intervention  ICMJE
  • Drug: Ublituximab
    Ublituximab (IV infusion)
  • Drug: Ibrutinib
    Ibrutinib oral daily dose
    Other Name: Ibrutinib (IMBRUVICA)
Study Arms Experimental: Ublituximab + ibrutinib
Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose
Interventions:
  • Drug: Ublituximab
  • Drug: Ibrutinib
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 4, 2016)
62
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2013)
60
Estimated Study Completion Date May 2019
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic Leukemia (CLL) enrollment arm is now closed.
  • Refractory to or relapsed after at least 1 prior treatment regimen
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

  • Any major surgery, chemotherapy or immunotherapy within the last 21 days
  • Known hepatitis B virus, hepatitis C virus or HIV infection
  • Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded.
  • Richter's transformation, prolymphocytic leukemia or primary central nervous system lymphoma
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers 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 NCT02013128
Other Study ID Numbers  ICMJE UTX-IB-104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party TG Therapeutics, Inc.
Study Sponsor  ICMJE TG Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jeff Sharman, MD Willamette Valley Cancer Institute
PRS Account TG Therapeutics, Inc.
Verification Date February 2019

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