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

Palo Alto (17 mi)

Overseen byMikkael A Sekeres

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 5 jurisdictions

Trial Summary

What is the purpose of this trial?This randomized phase II/III trial studies how well azacitidine works with or without lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether azacitidine is more effective with or without lenalidomide or vorinostat in treating myelodysplastic syndromes or chronic myelomonocytic leukemia.

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with MDS or CMML.

My genetic test results meet the study's requirements.

I have not taken specific medications for my condition before.

Exclusion Criteria

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

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

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

I have never used HDAC inhibitors for cancer treatment.

I do not have acute myeloid leukemia.

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

Treatment Details

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.

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.

Azacitidine is already approved in European Union, United States, Canada, Japan, Australia for the following indications:

🇪🇺 Approved in European Union as Vidaza for: