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

Sponsor

Henry Ford Health System (Other)

Overall Status

Recruiting

CT.gov ID

NCT03850418

Collaborator

(none)

Enrollment

Location

Arm

55.7

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

43 participants

Allocation:

N/A

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

Actual Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Feb 20, 2024

Anticipated Study Completion Date :

Feb 20, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: AZA

azacitidine

Drug: azacitidine

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

Outcome Measures

Primary Outcome Measures

The rate of increase or stable donor chimerism [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry ford hospital	Detroit	Michigan	United States	48202

Sponsors and Collaborators

Henry Ford Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shatha Farhan, Principal Investigator, Henry Ford Health System

ClinicalTrials.gov Identifier:

NCT03850418

Other Study ID Numbers:

12592

First Posted:

Feb 21, 2019

Last Update Posted:

Dec 27, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Neoplasms

Azacitidine

Study Results

No Results Posted as of Dec 27, 2021