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Anti-metabolites

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

Q: Has the FDA given clearance to Lenalidomide?

<p><a href="https://www.withpower.com/clinical-trials/lenalidomide">Lenalidomide</a>'s safety has been assessed to be a 2 on a 1-3 scale. This score is justified due to the existence of some data confirming its security, while there is no evidence attesting to its efficacy as it currently stands in Phase 2 clinical trials.</p>

Q: What other experiments have been done to gauge the efficacy of Lenalidomide?

<p><a href="https://www.withpower.com/clinical-trials/lenalidomide">Lenalidomide</a>'s clinical research began in 2004 at Midwest Center for Hematology <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a>, with 1165 studies having since been completed. The 465 currently recruiting trials are primarily concentrated around Decatur, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a>.</p>

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 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.

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

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 more

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

Lenalidomide

2005

Completed Phase 3

~1480

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,871 Total Patients Enrolled

Mikkael A SekeresPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT01522976 — Phase 2

Myelodysplastic Syndrome Research Study Groups: Arm III (azacitidine and vorinostat), Arm II (azacitidine), Arm I (azacitidine and lenalidomide)

Myelodysplastic Syndrome Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT01522976 — Phase 2

Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01522976 — Phase 2

Frequently Asked Questions

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

How many individuals is this research endeavor recruiting?

"This clinical trial has concluded its recruitment period. It was posted on 3rd March 2012 and the last update occurred 27 July 2022. For those looking for alternate studies, there are presently 2,715 trials involving leukemia, myelomonocytic chronic diseases searching for patients as well as 465 Lenalidomide specific ones."

Answered by AI

Has the FDA given clearance to Lenalidomide?

"Lenalidomide's safety has been assessed to be a 2 on a 1-3 scale. This score is justified due to the existence of some data confirming its security, while there is no evidence attesting to its efficacy as it currently stands in Phase 2 clinical trials."

Answered by AI

How broadly is this research being conducted across the country?

"Patients interested in participating can visit Heartland Cancer Research NCORP in Decatur, Illinois; NorthShore University HealthSystem-Evanston Hospital in Evanston, Delaware; or Christiana Care Health System-Christiana Hospital in Newark, Florida. There are a further 100 locations available to enroll patients."

Answered by AI

What other experiments have been done to gauge the efficacy of Lenalidomide?

"Lenalidomide's clinical research began in 2004 at Midwest Center for Hematology Oncology, with 1165 studies having since been completed. The 465 currently recruiting trials are primarily concentrated around Decatur, Illinois."

Answered by AI

Are there open spots in this research experiment for participants?

"It appears that clinicaltrials.gov shows this medical research is not presently recruiting participants, with its initial posting having occurred on March 1st 2012 and the latest update taking place in July 27th 2022. Although this trial is currently inactive, there are a substantial amount of 3180 other studies which are admitting patients."

Answered by AI

What are the usual indications for Lenalidomide as a therapeutic agent?

"Lenalidomide is clinically proven to treat a range of illnesses related to complete blood count, such as induction chemotherapy and myelocytic acute leukemia. As well, it can be used if the patient has undergone two prior systemic chemotherapies."

Answered by AI

What objectives is this research endeavor aiming to accomplish?

"The chief objective of this investigation, estimated to last up to 5 years, is Overall Survival (Phase III). Secondary aims are: Pre-study Cytogenetic Abnormalities which evaluates the cytogenetic risks involved; Relapse-free Survival measuring RFS from response date until relapse or death due to any cause; and finally, Overall Survival calculated for all patients starting at initial registration and ending with death due to any cause. All these outcomes will be estimated using Kaplan–Meier methods."

Answered by AI

Recent research and studies

BloodJournal

Comparable Outcomes of Patients Eligible Vs Ineligible for SWOG Leukemia Studies

Statler, Abby, Megan Othus, Harry P. Erba, Thomas R. Chauncey, Jerald P. Radich, Steven Coutre, Anjali Advani, et al.. 2018. “Comparable Outcomes of Patients Eligible Vs Ineligible for SWOG Leukemia Studies”. Blood. American Society of Hematology. doi:10.1182/blood-2018-01-826693.

clinicaltrials.govStudy

Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

2012. "Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01522976.

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