Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02281279

Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma

A Phase I/II Trial of Romidepsin, Rituximab and Lenalidomide (R3) in Relapsed/Refractory B Cell Lymphomas Including Transformed Follicular Lymphoma

Status
Withdrawn
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I/II trial studies the side effects and best dose of romidepsin and lenalidomide when combined with rituximab and to see how well this combination works in treating patients with B-cell non-Hodgkin lymphoma that has returned (recurrent) or did not respond to treatment (refractory). Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Romidepsin and lenalidomide may stop the growth of cancer cells by blocking enzymes needed for cell growth. Giving rituximab together with romidepsin and lenalidomide may be a better treatment for B-cell non-Hodgkin lymphoma.

Detailed description

PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) of the combination of romidepsin, rituximab and lenalidomide in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL). (Phase I) II. To assess the overall response rate (ORR) of this combination in patients with transformed follicular lymphoma (FL). (Phase II) SECONDARY OBJECTIVES: I. To assess the toxicity and safety of romidepsin in combination with lenalidomide and rituximab. II. To assess complete response rate (CR), progression free survival (PFS), and overall survival (OS) of this combination in patients with transformed FL. TERTIARY OBJECTIVES: I. To assess the impact of B-cell leukemia/lymphoma 2 (BCL2) mutations on ORR among patients treated with this combination. II. To assess the impact of BCL2 mutations on PFS among patients treated with this combination. OUTLINE: This is a phase I, dose-escalation study of romidepsin and lenalidomide followed by a phase II study. Patients receive rituximab intravenously (IV) over 90 minutes on day 1; romidepsin IV over 4 hours on either day 1, days 1 and 8, or days 1, 8, and 15; and lenalidomide orally (PO) on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALrituximabGiven IV
DRUGlenalidomideGiven PO
DRUGromidepsinGiven IV
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2016-10-01
Primary completion
2020-10-01
First posted
2014-11-03
Last updated
2016-08-11

Source: ClinicalTrials.gov record NCT02281279. Inclusion in this directory is not an endorsement.