Clinical Trials Directory

Trials / Completed

CompletedNCT02568553

Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma

A Phase I Trial of the Combination of Lenalidomide and Blinatumomab in Patients With Relapsed or Refractory Non-Hodgkins Lymphoma (NHL)

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
35 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial studies the side effects and best dose of lenalidomide and blinatumomab when given together in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement (relapsed). Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.

Detailed description

PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose (MTD) of lenalidomide when given in combination with blinatumomab in the proposed regimen. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity anti-tumor response (complete response \[CR\] and partial response \[PR\] as per International workshop lymphoma response criteria). II. To investigate the immune response to blinatumomab alone and in combination with lenalidomide. III. To document the infection rate with a 96-hour bag change schedule for blinatumomab. OUTLINE: This is a dose-escalation study of lenalidomide. INDUCTION: Patients receive blinatumomab intravenously (IV) continuously on days 1-56 and lenalidomide orally (PO) on days 29-49 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving response including stable disease receive blinatumomab IV continuously on days 1-7 and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receiving response including stable disease after completion of Consolidation receive lenalidomide PO on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALBlinatumomabGiven IV
DRUGLenalidomideGiven PO

Timeline

Start date
2016-11-15
Primary completion
2025-11-24
Completion
2025-11-24
First posted
2015-10-06
Last updated
2025-11-26

Locations

24 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02568553. Inclusion in this directory is not an endorsement.