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CD47 Antagonist

ALX148 + Rituximab + Lenalidomide for Lymphoma

Phase 1 & 2

Recruiting

Led By Paolo Strati

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Phase II: no prior systemic treatment for lymphoma

Symptomatic splenomegaly

Must not have

Difficulty with or unable to swallow oral medication, or disease affecting gastrointestinal function

CLL/SLL or LPL/Waldenstrom macroglobulinemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time by which measurement criteria for cr or pr, whichever is recorded first, is met until death or the first date by which progressive disease is documented, assessed up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of immunotherapy and chemotherapy drugs to treat B-cell non-Hodgkin lymphoma.

Who is the study for?

This trial is for adults with various types of B-cell non-Hodgkin lymphoma, including those who haven't had treatment or have tried at least one therapy without success. Participants should be in good physical condition, not have HIV or active hepatitis, and must not be pregnant. They can't join if they've had certain recent surgeries, uncontrolled diseases, a history of severe allergies to study drug components, or are on strong immune system suppressants.

What is being tested?

The trial tests the combination of ALX148 (an immunotherapy), rituximab (a monoclonal antibody), and lenalidomide (a chemotherapy drug) to see how well they work together against indolent and aggressive B-cell non-Hodgkin lymphoma. It aims to find the best dose and assess benefits/side effects.

What are the potential side effects?

Possible side effects include reactions related to the immune system's changes due to ALX148, infusion-related reactions from rituximab, and typical chemotherapy-associated issues like fatigue, digestive problems from lenalidomide. There may also be risks associated with combining these treatments.

Eligibility Criteria

Inclusion Criteria

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

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I have not received any systemic treatment for my lymphoma.

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I have an enlarged spleen that causes discomfort.

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I have tried at least one treatment without success and cannot receive standard curative care.

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I have a specific type of B-cell lymphoma.

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My cancer is near or affecting my organs.

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My cancer involves a large tumor or multiple sites larger than 3 cm.

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I am fully active or can carry out light work.

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My cancer is advanced with a high number of tumors.

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I am 18 years old or older.

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I have a confirmed diagnosis of follicular lymphoma (grade 1, 2, or 3a) or marginal zone lymphoma.

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I have been diagnosed with B-cell Non-Hodgkin's Lymphoma.

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I have not received any systemic treatment for my lymphoma.

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I have had fever, night sweats, or significant weight loss without a clear reason.

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My blood counts are low because of my lymphoma.

Exclusion Criteria

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

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I have trouble swallowing pills or have a digestive condition.

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I have been diagnosed with CLL/SLL or Waldenstrom macroglobulinemia.

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I have HIV, active hepatitis B or C, or another serious infection that is not under control.

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I have taken less than 10 mg/day of prednisone or no corticosteroids in the last 4 weeks.

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I have not had major surgery in the last 28 days or minor surgery in the last 3 days.

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I have active cancer in my brain or spinal cord.

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I have a serious illness or organ problem that threatens my life.

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I have a serious heart condition.

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I do not have any current bleeding or a disorder that causes excessive bleeding.

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My neuropathy is mild or I don't have it.

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I have uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia.

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I have been treated for an autoimmune disease in the last 2 years.

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I have had symptoms from a blood clot in my veins or lungs.

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I have had pneumonitis treated with steroids or have it now.

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I have previously been treated with lenalidomide or a CD47/SIRP alpha inhibitor.

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I have a weakened immune system or am taking drugs that lower my immunity.

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I need ongoing treatment with strong CYP3A inhibitors.

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I have been diagnosed with Burkitt lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time by which measurement criteria for cr or pr, whichever is recorded first, is met until death or the first date by which progressive disease is documented, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time by which measurement criteria for cr or pr, whichever is recorded first, is met until death or the first date by which progressive disease is documented, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time by which measurement criteria for cr or pr, whichever is recorded first, is met until death or the first date by which progressive disease is documented, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Complete remission (CR) rate (Phase II)

Secondary study objectives

Duration of response

Incidence of treatment-emergent AEs requiring temporary or permanent discontinuation of study drug or dose reductions

Incidence of treatment-emergent adverse events (AEs)

+3 more

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 (ALX148, rituximab, lenalidomide)Experimental Treatment3 Interventions

Patients receive ALX148 IV over 1 hour once on days 1, 8, 15 and 22, or days 1 and 15, or day 1 depending on dose level. Patients also receive rituximab IV over 4-6 hours on days 1, 8, 15 and 22 of cycle 1, then on day 1 of cycles 2-6, and lenalidomide PO QD on days 1-21 of cycles 1-6. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~2240

Rituximab

1999

Completed Phase 4

~2990