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Anti-metabolites

Azacitidine +/− Lenalidomide/Vorinostat for Higher-Risk MDS/CMML

Phase 2

Waitlist Available

Led By Mikkael A Sekeres

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

Patients must have morphologically confirmed diagnosis of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) based on specific classifications

Cytogenetics requirements must be met based on the specific protocol

Must not have

Patients must not have history of thromboembolic event or other condition requiring current use of anticoagulation with Coumadin (warfarin) or low molecular-weight heparin

Patients must not have pre-existing neurotoxicity/neuropathy of >= grade 2 or prior >= grade 3 allergic reaction/hypersensitivity or rash to thalidomide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well azacitidine works with or without lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukemia.

Who is the study for?

This trial is for adults with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukemia. Participants must have a specific diagnosis, not received certain treatments recently, and have an acceptable level of overall health and organ function. They should not be on anticoagulation therapy or have had previous stem cell transplants.

What is being tested?

The study is testing the effectiveness of azacitidine alone versus in combination with either lenalidomide or vorinostat in treating patients. It aims to determine which treatment stops cancer growth more effectively by comparing these different drug combinations.

What are the potential side effects?

Potential side effects may include reactions at the injection site, fatigue, nausea, blood count changes leading to increased infection risk or bleeding problems, and possible heart-related issues due to lenalidomide.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with MDS or CMML.

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My genetic test results meet the study's requirements.

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I have not taken specific medications for my condition before.

Exclusion Criteria

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

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I am not currently using blood thinners like warfarin or heparin.

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I don't have severe nerve damage or serious allergies to thalidomide.

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I have never had a bone marrow or stem cell transplant from another person.

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I have never used HDAC inhibitors for cancer treatment.

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I do not have acute myeloid leukemia.

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I haven't taken epilepsy medication like valproic acid in the last 30 days.

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

Overall Survival (Phase III)

Response Rate (Phase II)

Secondary study objectives

Overall Survival

Pre-study Cytogenetic Abnormalities

Relapse-free Survival

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm III (azacitidine and vorinostat)Experimental Treatment3 Interventions

Patients receive azacitidine as in Arm I and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (azacitidine)Experimental Treatment2 Interventions

Patients receive azacitidine as in Arm I. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Group III: Arm I (azacitidine and lenalidomide)Experimental Treatment3 Interventions

Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

2012

Completed Phase 3

~1440

Vorinostat

2014

Completed Phase 3

~1600