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
Trial end date:
2023-10-01
Target enrollment:
0
Participant gender:
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 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborators:
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