A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL

Completed · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Mantle Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT02268851

Run by

Dana-Farber Cancer Institute

People needed

45

Starts

2014-11-01

Expected to finish

2022-10-01

Last updated by the study team

2024-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Pacific Cancer Care — Monterey, California, United States
• St. Francis Hospital and Cancer Center — Hartford, Connecticut, United States
• Eastern Maine Medical Center/ Northern Light Cancer Care — Brewer, Maine, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Beth Israel Deaconness Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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