Lenalidomide + Blinatumomab for Lymphoma

Recruiting at25 trial locations

Overseen by Joseph M. Tuscano

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Joseph M. Tuscano

Principal Investigator

City of Hope Comprehensive Cancer Center LAO

Eligibility Criteria

This trial is for adults with various types of relapsed Non-Hodgkin Lymphoma who have tried at least two prior treatments and are not eligible for standard cures. They must have measurable disease, normal organ function tests, no brain metastases or uncontrolled illnesses, and not be pregnant or breastfeeding. HIV-positive patients can join if they meet certain conditions.

Inclusion Criteria

Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal

Patients must have radiographically measurable disease

Platelets >= 50,000/mcL

Exclusion Criteria

Patients receiving any other investigational agents

I have an active hepatitis B or C infection.

I haven't had chemotherapy or radiotherapy in the last 4 weeks.

Treatment Details

Interventions

• Blinatumomab (Monoclonal Antibodies)
• Lenalidomide (Immunomodulatory Agent)

Trial Overview The trial is testing the combination of Lenalidomide and Blinatumomab to find the safest doses and observe side effects in treating relapsed Non-Hodgkin Lymphoma. Lenalidomide boosts the immune system while Blinatumomab targets cancer cells directly.

Participant Groups

Group I: Treatment (blinatumomab, lenalidomide) Experimental Treatment 2 Interventions

INDUCTION: Patients receive blinatumomab IV continuously on days 1-56 and lenalidomide 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School