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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

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete remission (CR) rate (Phase II)

Recommended phase II dose (RP2D) and schedule of ALX148 (Phase I)

Secondary outcome measures

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

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

~1480

Rituximab

1999

Completed Phase 4

~1880

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,274 Total Patients Enrolled

Paolo StratiPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

80 Total Patients Enrolled

Paolo Strati, MDPrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

62 Total Patients Enrolled

Media Library

ALX148 (CD47 Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05025800 — Phase 1 & 2

Non-Hodgkin's Lymphoma Research Study Groups: Treatment (ALX148, rituximab, lenalidomide)

Non-Hodgkin's Lymphoma Clinical Trial 2023: ALX148 Highlights & Side Effects. Trial Name: NCT05025800 — Phase 1 & 2

ALX148 (CD47 Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05025800 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical issues does CD47 Antagonist ALX148 typically treat?

"ALX148, a CD47 Antagonist, is an effective therapy for those suffering from diffuse large b-cell lymphoma (dlbcl) as well as certain other forms of b-cell lymphomas that have already been treated with two prior systemic chemotherapy regimens."

Answered by AI

Is this trial still seeking participants?

"According to data posted on clinicaltrials.gov, this medical trial is still accepting participants and was originally listed on October 13th 2021 with a last update made in September 19th 2022."

Answered by AI

How many individuals are presently participating in this clinical evaluation?

"Affirmative. According to clinicaltrials.gov, this research is actively recruiting candidates, with the initial post being dated October 13th 2021 and the last update occurring on September 19th 2022. In total, 52 patients are needed at 1 single location."

Answered by AI

What effect is the research expected to have on participants?

"This clinical trial's primary assessment parameter, to be measured over a span of up to 28 days is complete remission (CR) rate. Secondary outcomes cover progression-free survival and the incidence of treatment-emergent adverse events that may require temporary or permanent cessation/reduction in study drug dosages. These will all be evaluated using Kaplan-Meier methodology and summarised through tables, listings and percentages based on severity & relationship to medicine."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ALX148, Rituximab and Lenalidomide for the Treatment of Indolent and Aggressive B-cell Non-Hodgkin Lymphoma

2021. "ALX148, Rituximab and Lenalidomide for the Treatment of Indolent and Aggressive B-cell Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05025800.

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