Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I/II Trial of Romidepsin, Rituximab and Lenalidomide (R3) in Relapsed/Refractory B Cell Lymphomas Including Transformed Follicular Lymphoma
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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