Lenalidomide, Ixazomib, and Rituximab as Front-Line Therapy for High Risk Indolent B-Cell Lymphoma
Recruiting in Palo Alto (17 mi)
+1 other location
BH
Overseen byBrian Hill, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Brian Hill, MD, PhD
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
A Phase IB/II Trial of Lenalidomide (Revlimid®), Ixazomib and Rituximab (RIXAR) as Front-line Therapy for High Risk Indolent B cell Lymphoma
Research Team
BH
Brian Hill, MD, PhD
Principal Investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Eligibility Criteria
Inclusion Criteria
Evidence of compression syndrome (e.g., ureteral, orbital, gastrointestinal) or pleural or peritoneal serous effusion due to lymphoma (irrespective of cell content)
Follicular lymphoma grades 1, 2, and 3a
Marginal zone B-cell lymphoma, including extranodal (MALT), nodal and splenic. Excluding: Small lymphocytic lymphoma Lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (WM)
See 7 more
Treatment Details
Interventions
- Ixazomib (Proteasome Inhibitor)
- Lenalidomide (Immunomodulatory Agent)
- Rituximab (Monoclonal Antibody)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Lenalidomide + Ixazomib + RituximabExperimental Treatment3 Interventions
Ixazomib will be orally administered with a starting dose of 2.0mg. Lenalidomide will be administered orally with a starting dose of 20mg. Rituximab will be administered intravenously at the standard dose of 375mg/m2. The study will use a standard 3 + 3 design for determination of MTD during cycle 1. There will be three dose levels for escalation, followed by two expansion cohorts of 12 patients each at the MTD, one cohort with follicular lymphoma and one cohort with non-follicular low-grade lymphoma (SLL, marginal zone, lymphoplasmacytic). Patients will be treated for 12 cycles of 4 week duration.
Ixazomib is already approved in Canada, Japan for the following indications:
Approved in Canada as Ninlaro for:
- Multiple myeloma in combination with lenalidomide and dexamethasone
Approved in Japan as Ninlaro for:
- Multiple myeloma in combination with lenalidomide and dexamethasone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brian Hill, MD, PhD
Lead Sponsor
Trials
3
Recruited
90+
Brian Hill
Lead Sponsor
Trials
2
Recruited
60+
The Cleveland Clinic
Collaborator
Trials
1,072
Recruited
1,377,000+
David Peter
The Cleveland Clinic
Chief Medical Officer
MD, board-certified in Hospice and Palliative Medicine
Tomislav Mihaljevic
The Cleveland Clinic
Chief Executive Officer since 2018
MD from University of Zagreb School of Medicine