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Monoclonal Antibodies

Lenalidomide + Blinatumomab for Lymphoma

Phase 1

Waitlist Available

Led By Joseph M Tuscano

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body surface area (BSA)-normalized creatinine clearance >= 60 mL/min/1.73 m^2

Patients must have had at least two prior chemotherapeutic or biologic regimens

Must not have

Concurrent use of other anti-cancer agents or treatments

Known active hepatitis, type B or C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of lenalidomide and blinatumomab when given together to patients with non-Hodgkin lymphoma that has returned after a period of improvement.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include allergic reactions similar to other compounds like lenalidomide and blinatumomab, infections due to a weakened immune system, heart issues such as congestive heart failure or angina, liver problems from hepatitis B or C, psychiatric illness affecting study compliance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have undergone at least two different cancer treatments.

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My lymphoma has returned and tests positive for CD19.

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I can care for myself but may need occasional help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not using any other cancer treatments.

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I have an active hepatitis B or C infection.

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I have cancer that has spread to my brain.

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I do not have any unmanaged ongoing illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of toxicity

Secondary study objectives

Changes in the frequency of CD4+ T cells

Changes in the production of interferon (INF)-gamma from CD4+ T cells

Clinical anti-tumor response (complete response and partial response as per International workshop lymphoma response criteria)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blinatumomab

2014

Completed Phase 3

~1230

Lenalidomide

2005

Completed Phase 3

~2240