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