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Azacitidine +/− Lenalidomide/Vorinostat for Higher-Risk MDS/CMML
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Arm III (azacitidine and vorinostat)
- Group 2: Arm II (azacitidine)
- Group 3: Arm I (azacitidine and lenalidomide)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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