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Recruiting NCT03850418

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

Phase II Interventional Myeloid Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: azacitidine.
Who it may be relevant to
Registry conditions: Myeloid Malignancy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

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

Primary outcome measures

  • The rate of increase or stable donor chimerism [Time frame: one year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Henry ford hospital — Detroit

Identifiers

NCT: NCT03850418 · 12592

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗