Status:
COMPLETED
A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
TG Therapeutics, Inc.
The Leukemia and Lymphoma Society
Conditions:
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This research study will be evaluating the safety and efficacy of a study drug called TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible treatment for Chronic ...
Detailed Description
This research study is a Phase I and Ib combination clinical trial, which aims to both evaluate the safety of an investigational drug combination and also tries to define the appropriate dose of the i...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia (CLL), or Small Lymphocytic Lymphoma (SLL)
- Adequate organ system function ( Absolute neutrophil count, Platelets,Bilirubin, Platelets, Aspartate transferase ,Alanine aminotransferase, Creatinine Clearance)
- Eastern Cooperative Group (ECOG) Performance status ≤ 2
- Ability to swallow and retain oral medication
- Female patients: must have negative serum pregnancy test at study screening/ all male partners must consent to use a medically acceptable method of contraception
- Willingness and ability to comply with trial and follow-up procedures, and give written informed consent
Exclusion
- Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) within 3 weeks of Cycle 1/Day 1,
- Autologous hematologic stem cell transplant within 3 months of study entry.
- Allogeneic hematologic stem cell transplant within 12 months.
- Post-allo patients must not have active graft versus-host disease
- Evidence of active Hepatitis B,Hepatitis C or HIV infection.
- Active central nervous system involvement by lymphoma
- Requires treatment with strong CYP3A4/5 inhibitors
- Severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- QTcF \>470 msec (QT interval, Fredericia calculation)
- Angina not well-controlled by medication
- Poorly controlled or clinically significant atherosclerotic vascular disease
- Presence of other active cancers, or history of treatment for invasive cancer within the past 2 years.
- Require warfarin for anticoagulation
- Women who are pregnant or lactating
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02268851
Start Date
November 1 2014
End Date
October 1 2022
Last Update
November 15 2024
Active Locations (5)
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1
Pacific Cancer Care
Monterey, California, United States, 93940
2
St. Francis Hospital and Cancer Center
Hartford, Connecticut, United States, 06105
3
Eastern Maine Medical Center/ Northern Light Cancer Care
Brewer, Maine, United States, 04412
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115