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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03850418
Recruitment Status : Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Information provided by (Responsible Party):
Shatha Farhan, Henry Ford Health System

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

Condition or disease Intervention/treatment Phase
Myeloid Malignancy Drug: azacitidine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : February 20, 2024
Estimated Study Completion Date : February 20, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Azacitidine

Arm Intervention/treatment
Experimental: AZA
Drug: azacitidine
azacitidine 32mg/m2 x 5 days every 28 days for minimum of 4 cycles if tolerated

Primary Outcome Measures :
  1. The rate of increase or stable donor chimerism [ Time Frame: one year ]
    To determine the rate of increase or stable donor chimerism when using low dose azacitidine post allogenic stem cell transplant (SCT) in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) and myeloproliferative neoplasms (MPN) with documented low or decreasing donor chimerism

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03850418

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Contact: shatha farhan, MD 313 713 3910 SFARHAN1@HFHS.ORG
Contact: NALINI JANAKIRAMAN 313 916 5002

Sponsors and Collaborators
Henry Ford Health System

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Responsible Party: Shatha Farhan, Principal Investigator, Henry Ford Health System Identifier: NCT03850418     History of Changes
Other Study ID Numbers: 12592
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors