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

NCT ID: NCT03850418

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2026-02-20

Brief 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

Conditions

Myeloid Malignancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AZA

azacitidine

Group Type: EXPERIMENTAL

azacitidine

Intervention Type: DRUG

azacitidine 32mg/m2 x 5 days every 28 days for minimum of 4 cycles if tolerated

Interventions

azacitidine

azacitidine 32mg/m2 x 5 days every 28 days for minimum of 4 cycles if tolerated

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Shatha Farhan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry ford hospital

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

shatha farhan, MD

Role: CONTACT

SFARHAN1@HFHS.ORG

313 916 5002

NALINI JANAKIRAMAN, MD

Role: CONTACT

Facility Contacts

shatha farhan

Role: primary

313-916-5002

Other Identifiers

12592

Identifier Type: -

Identifier Source: org_study_id