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Luspatercept + Lenalidomide for Myelodysplastic Syndrome

Phase 1 & 2

Recruiting

Research Sponsored by Mikkael Sekeres MD

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 (Appendix 1)

- average transfusion requirement of ≥ 2 units/8 weeks of packed Red Blood Cells (pRBC) s confirmed for a minimum of 16 weeks immediately preceding C1D1.

Must not have

MDS associated with del 5q cytogenetic abnormality

- other RBC hematopoietic growth factors (eg, Interleukin-3)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if combining Lenalidomide and Luspatercept will help treat anemia in patients with lower-risk Myelodysplastic Syndrome.

Who is the study for?

Adults with lower-risk Myelodysplastic Syndrome (MDS) who haven't responded to or can't take Erythropoiesis-stimulating agents, and need regular blood transfusions. Participants must not be pregnant, agree to contraception if of childbearing potential, have no severe medical conditions or recent major surgeries, and cannot have had certain prior treatments like stem cell transplants.

What is being tested?

The trial is testing whether combining two drugs, Luspatercept and Lenalidomide (referred to as L2), is effective in treating anemia in patients with MDS that doesn't involve chromosome 5q deletion. The study aims to see if this drug combo improves upon current anemia treatments.

What are the potential side effects?

Potential side effects for these medications may include fatigue, dizziness, blood clots, diarrhea or constipation. There might also be risks of more serious conditions such as hypertension or deep vein thrombosis but specifics will vary by individual.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself and perform daily activities.

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I have needed at least 2 blood transfusions every 8 weeks for the last 16 weeks.

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My condition did not improve with previous ESA treatment.

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My MDS is classified as very low, low, or intermediate risk with less than 5% blasts.

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I am 18 years or older and can sign the consent form.

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I have been taking a high dose of erythropoietin for at least 8 doses.

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I have received darbepoetin alpha or a similar treatment.

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I cannot use ESAs due to high erythropoietin levels (>200 U/L) and have not been treated with ESAs before.

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I need regular blood transfusions.

Exclusion Criteria

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

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My MDS is linked to a specific genetic change (del 5q).

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I am not taking any red blood cell growth factors like Interleukin-3.

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I have anemia caused by a deficiency or bleeding.

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My high blood pressure is not controlled, even with treatment.

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I have not had major surgery in the last 4 weeks and have fully recovered from any past surgeries.

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I have been treated with luspatercept or sotatercept before.

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My prostate cancer was found by accident and is classified as T1a or T1b.

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I have been treated with Lenalidomide before.

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I haven't had a stroke, DVT, or blood clots in my lungs or arteries in the last 6 months.

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I have been diagnosed with acute myeloid leukemia (AML).

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I have not taken any anticancer chemotherapy drugs.

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I have a non-invasive breast cancer.

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I have early-stage cervical cancer.

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I have had a stem cell transplant from a donor.

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I have been diagnosed with basal or squamous cell skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

DLT Rate for Phase Ib

MTD/RP2D of Luspatercept combined with Lenalidomide

Percentage of participants with RBC-TI response

+1 more

Secondary study objectives

Duration of RBC-TI

Overall Survival (OS)

Percentage of participants experiencing a progression to higher-risk MDS or AML

+5 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: Luspatercept + Lenalidomide GroupExperimental Treatment2 Interventions

Phase 1B: Luspatercept will be administered at starting dose 1.0 mg/kg and can be titrated to 1.33 and 1.75 mg/kg dependent on participant response. Lenalidomide will be administered in a dose escalation design between 3 cohorts to determine MTD (2.5 mg, 5 mg and 10 mg daily dose on a 21-day cycle). MTD will be defined as the dose level with 0 or 1 DLT out of 6 participants. MTD will be declared as the RP2D for the Phase II portion of the study. Phase II: Luspatercept will be administered at 1.0 mg/kg and can be titrated to 1.33 and 1.75 mg/kg dependent on participant response. Lenalidomide will be administered with the RP2D daily for 21 days on a 21 day cycle. Treatment with combination of Lenalidomide and Luspatercept will continue as long as a participant is deriving clinical benefit, in the opinion of the treating physician, for up to 5 years or until disease progression or treatment intolerance.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Luspatercept

2018

Completed Phase 3

~1240

Lenalidomide

2005

Completed Phase 3

~2240