Acute Myeloid Leukemia Clinical Trial

Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant

Summary

Previous studies provide a rationale for administration of AZA after allo SCT for decreasing chimerism. The investigators hypothesize that azacitidine can be well tolerated after SCT and help decrease rate of decreasing donor chimerism and hence decrease relapse without increasing GVHD

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients with AML/MDS/MPN, CMML post Allogeneic SCT who experience any drop in total or myeloid chimerism any time after day 30, or their day 30 or day100 myeloid donor chimerism is below 98% without concurrent hematologic relapse (that is, patients with <5% bone marrow blasts as obtained at that time point) will be offered treatment with azacitidine
>=30 -180 days post SCT and patients must have ANC> 1000, PLT > 50,000
Age 18-75 years old
Performance score of at least 70% by Karnofsky

Adequate kidney and liver function as demonstrated by:

Creatinine clearance should be >60 ml/min
Total Bilirubin <1.5, ALT/AST/Alk Phos < 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
Patients must be off any prior chemotherapy, radiotherapy, or other investigational therapy within 2 weeks prior to start treatment

Exclusion Criteria:

Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
Active or prior CNS leukemia, unless in complete remission for at least 2 months.
History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
Uncontrolled infection
Grade III, IV graft versus host disease (GVHD

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

43

Study ID:

NCT03850418

Recruitment Status:

Recruiting

Sponsor:

Henry Ford Health System

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There is 1 Location for this study

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Henry ford hospital
Detroit Michigan, 48202, United States More Info
shatha farhan
Contact
313-916-5002

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

43

Study ID:

NCT03850418

Recruitment Status:

Recruiting

Sponsor:


Henry Ford Health System

How clear is this clinincal trial information?

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