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TGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT02100852
Recruitment Status : Completed
First Posted : April 1, 2014
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil in patients with chronic lymphocytic leukemia.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: TGR-1202 + Obinutuzumab + Chlorambucil Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of TGR-1202, a Novel PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
Actual Study Start Date : March 12, 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017


Arm Intervention/treatment
Experimental: TGR-1202 + Obinutuzumab + Chlorambucil
TGR-1202 is an oral daily dose with obinutuzumab at a fixed IV infusion and chlorambucil as an oral dose on specified days.
Drug: TGR-1202 + Obinutuzumab + Chlorambucil
TGR-1202: Oral dose Obinutuzumab: IV infusion Chlorambucil: Oral dose
Other Names:
  • Obinutuzumab: Gazyva
  • Chlorambucil: Leukeran




Primary Outcome Measures :
  1. Maximum Tolerated Dose acceptable for participants [ 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


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 1 year ]
    To assess the overall response rate (ORR) in patients with chronic lymphocytic leukemia treated with TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed Chronic Lymphocytic Leukemia (CLL)
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
  • Ability to swallow oral medication

Exclusion Criteria:

  • Known hepatitis B virus, hepatitis C virus or HIV infection
  • Primary central nervous system lymphoma or known intracranial involvement
  • Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100852


Locations
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United States, Alabama
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States, 35805
United States, Tennessee
TG Therapeutics Investigational Trial Site
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
TG Therapeutics, Inc.
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02100852    
Other Study ID Numbers: TGR-GA-106
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Obinutuzumab
Chlorambucil
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action