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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (Phase III)
Response Rate (Phase II)
Secondary outcome measures
Overall Survival
Pre-study Cytogenetic Abnormalities
Relapse-free Survival
+1 moreTrial 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
~1410
Vorinostat
2014
Completed Phase 3
~1600
Lenalidomide
2005
Completed Phase 2
~1070
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,081 Total Patients Enrolled
Mikkael A SekeresPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently using blood thinners like warfarin or heparin.I have never had a bone marrow or stem cell transplant from another person.I do not have any major health, lab, or mental health issues.I have never used HDAC inhibitors for cancer treatment.I have not had cancer before, except for certain types that are exceptions.My genetic test results meet the study's requirements.I have not taken specific medications for my condition before.I am able to have children and will follow the pregnancy testing and contraception rules if I receive lenalidomide.I don't have severe nerve damage or serious allergies to thalidomide.I have been diagnosed with MDS or CMML.My tests for cancer were done within the last 30 days.I do not have acute myeloid leukemia.I haven't had specific treatments recently.I haven't taken epilepsy medication like valproic acid in the last 30 days.I haven't had specific treatments recently.
Research Study Groups:
This trial has the following groups:- Group 1: Arm III (azacitidine and vorinostat)
- Group 2: Arm II (azacitidine)
- Group 3: Arm I (azacitidine and lenalidomide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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