Overview
A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2023-10-01
2023-10-01
Target enrollment:
0
0
Participant gender:
All
All
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 Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle Cell Lymphoma (MCL) that has come back or that has not responded to standard treatment.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Dana-Farber Cancer InstituteCollaborators:
Blood Cancer Research Partnership
TG Therapeutics, Inc.
The Leukemia and Lymphoma Society
Criteria
Inclusion Criteria:- 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 Criteria:-
- 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