Mantle Cell Lymphoma Clinical Trial
Official title:
A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of the Novel PI3k Delta Inhibitor TGR-1202 in Combination With Ibrutinib in Patients With Select B-Cell Malignancies
Verified date | May 2024 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | August 2023 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconness Medical Center | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Eastern Maine Medical Center/ Northern Light Cancer Care | Brewer | Maine |
United States | St. Francis Hospital and Cancer Center | Hartford | Connecticut |
United States | Pacific Cancer Care | Monterey | California |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Blood Cancer Research Partnership, TG Therapeutics, Inc., The Leukemia and Lymphoma Society |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I | To assess the safety of TGR1202 in combination with ibrutinib relapsed or refractory CLL or MCL. DLT is based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. DLT refers to toxicities experienced at any time during the study treatment, defined as Grade 4 anemia; Grade 4 neutropenia lasting >7 days (while receiving growth factor support); Grade 4 thrombocytopenia lasting > 7 days; Grade =3 febrile neutropenia; and Grade =3 thrombocytopenia with Grade >2 hemorrhage;Grade = 3 non-hematologic toxicity unresponsive to standard supportive care measure with the exception of asymptomatic Grade =3 lab abnormalities that resolve to = Grade 1 or baseline within 7 days;treatment delay of =14 days due to unresolved toxicity; and non-hematologic toxicity of Grade 2 (at any time during treatment) that, in the judgment of the Investigators, Study Chair, and the Medical Monitor, is dose-limiting. | Participants were assessed every week or more often as needed during Cycle 1 or more often for up to 28 days to assess Dose-limiting toxicities (DLTs) during Phase I | |
Secondary | Overall Response Rate | Response and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008) by Lugano Criteria ( Cheson et al,.24) for MCL | At baseline, End of Cycle 2, End of Cycle 5, End of Cycle 9, End of Cycle 14 and approximately q6 months until C26, then investigator discretion thereafter | |
Secondary | Rate of Nodal Response With Lymphocytosis (nPR) | 2 years | ||
Secondary | Rate of Progression Free Survival | 2 Years | ||
Secondary | Duration of Response | 2 Years |
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