Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
84

Summary

Conditions
Mantle Cell Lymphoma
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Phase I: Standard 3+3 design with the primary objective of determining the maximum tolerate dose (MTD)/recommended phase 2 dose (RP2D) of this combination in MCL. Both ibrutinib-pretreated and ibrutinib-naïve patients will be enrolled. Phase II: Dose Level 2 is the RP2D. Patients will be enrolled to two cohorts, based on prior ibrutinib treatment: BTK-naïve and BTK-pretreated (BTK pretreated closed 8/7/2020) .Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

MCL is a rare subtype of non-Hodgkin lymphoma that is considered incurable with conventional therapy. For relapsed patients, Ibrutinib, lenalidomide, and bortezomib are all approved by the FDA but are not curative. Novel approaches are required to improve outcomes for patients with relapsed/refracto...

MCL is a rare subtype of non-Hodgkin lymphoma that is considered incurable with conventional therapy. For relapsed patients, Ibrutinib, lenalidomide, and bortezomib are all approved by the FDA but are not curative. Novel approaches are required to improve outcomes for patients with relapsed/refractory MCL. This is an open-label study that will be done in 2 phases. Phase I will test different doses of ixazomib and ibrutinib to determine the maximum safe and tolerated dose. In Phase I, patients who have already received ibrutinib, may participate if they meet certain criteria (i.e., have not received ibrutinib for at least 3 months). Phase I was completed November 25, 2019. Dose Level 2 (Ixazomib 4 mg and Ibrutinib 560 mg) is the recommended Phase II dose. Phase II will find out the effects, good and/or bad, of ixazomib in combination with ibrutinib. In Phase II, patients will be separated into 2 groups, patients who have never received a Bruton's Tyrosine Kinase (BTK) inhibitor and patients who have received a BTK inhibitor. This study is designed to examine the effectiveness of this drug in treating patients with MCL. Patients will be treated until progression or unacceptable toxicity. Tumor assessments will be performed approximately every 3 months for the first year of treatment, then every 6 months until progression. Mandatory bone marrow and tumor tissue samples (i.e., obtained during a previous procedure or biopsy) are required at baseline. Mandatory research blood samples will also be collected. 8/7/2020: Enrollment stopped to patients who have already received a BTK inhibitor. Total of two patients enrolled.

Tracking Information

NCT #
NCT03323151
Collaborators
Takeda
Investigators
Study Chair: Jonathon B Cohen, MD Emory University - Winship Cancer Institute