RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2019-07-01

Study Completion:2026-02-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03850418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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 2. \>=30 -180 days post SCT and patients must have ANC\> 1000, PLT \> 50,000 3. Age 18-75 years old 4. Performance score of at least 70% by Karnofsky 5. Adequate kidney and liver function as demonstrated by: 1. Creatinine clearance should be \>60 ml/min 2. Total Bilirubin \<1.5, ALT/AST/Alk Phos \< 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis. 6. 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. 7. Patient or patient's legal representative, parent(s) or guardian able to sign informed consent. 8. Patients must be off any prior chemotherapy, radiotherapy, or other investigational therapy within 2 weeks prior to start treatment	1. Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause 2. Active or prior CNS leukemia, unless in complete remission for at least 2 months. 3. History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs. 4. Uncontrolled infection 5. Grade III, IV graft versus host disease (GVHD

Inclusion Criteria

Exclusion Criteria

1. 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
2. \>=30 -180 days post SCT and patients must have ANC\> 1000, PLT \> 50,000
3. Age 18-75 years old
4. Performance score of at least 70% by Karnofsky
5. Adequate kidney and liver function as demonstrated by:
1. Creatinine clearance should be \>60 ml/min
2. Total Bilirubin \<1.5, ALT/AST/Alk Phos \< 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
6. 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.
7. Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
8. Patients must be off any prior chemotherapy, radiotherapy, or other investigational therapy within 2 weeks prior to start treatment

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

Contacts and Locations

Study Contact

shatha farhan, MD

CONTACT

313 916 5002

SFARHAN1@HFHS.ORG

NALINI JANAKIRAMAN, MD

CONTACT

Study Locations (Sites)

Henry ford hospital

Detroit, Michigan, 48202

United States

Collaborators and Investigators

Sponsor: Henry Ford Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-01

Study Completion Date2026-02-20

Study Record Updates

Study Start Date2019-07-01

Study Completion Date2026-02-20

Terms related to this study

Additional Relevant MeSH Terms

Myeloid Malignancy