Lenalidomide + Blinatumomab for Lymphoma

Recruiting in Palo Alto (17 mi)

+25 other locations

Overseen ByJoseph 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.

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

My kidneys work well enough to clear waste from my body.

I have undergone at least two different cancer treatments.

My lymphoma has returned and tests positive for CD19.

I can care for myself but may need occasional help.

Exclusion Criteria

I am not using any other cancer treatments.

I have an active hepatitis B or C infection.

I have cancer that has spread to my brain.

I do not have any unmanaged ongoing illnesses.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Treatment (blinatumomab, lenalidomide)Experimental Treatment2 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.

Blinatumomab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Blincyto for: