Maintenance Low Dose 5'-Azacitidine Post T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndrome and Acute Myelogenous Leukemia With High Risk for Post-Transplant Relapse



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:1 - 75
Updated:10/31/2018
Start Date:December 2013
End Date:November 2019
Contact:Roni Tamari, MD
Phone:212-639-5987

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A Single Arm Phase II Trial of Maintenance Low Dose 5'-Azacitidine Post T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndrome and Acute Myelogenous Leukemia With High Risk for Post-Transplant Relapse

The purpose of this study is to learn if 5'-Azacitidine will help to lower the risk of the
disease coming back after a stem cell transplant in patients with MDS and AML. This study
will also be looking at the side effects of this medicine.

5'-Azacitidine is an FDA approved drug for treatment of MDS and AML, as well as patients
whose disease came back after transplant, where it helped going into remission. It is unclear
if 5'-Azacitidine can prevent the disease from coming back after transplant. This study will
help show if getting 5'-Azacitidine soon after transplant can lower the risk of your disease
coming back.


Inclusion Criteria:

Patients who have undergone T cell depleted allogeneic hematopoietic stem cell
transplantation at MSKCC for:

- De novo myelodysplastic syndromes (MDS): IPSS-1 with poor risk cytogenetics or higher
IPSS.

- Acute myelogenous leukemia (AML) in first remission that required more than 1 cycle of
treatment to achieve remission or with the following cytogenetic abnormalities: FLT3
mutation, deletion/monosomy of chromosome 5 or 7, MLL gene rearrangement, or more than
or equal to 3 cytogenetics abnormalities. Also patients in second or greater
remission.

- Patients with Secondary MDS/AML.

- Patients will be considered eligible for the study if after transplant they achieved
hematologic (<5% blasts) and cytogenetic remission.

- Patients will be eligible to enter the study between 60-120 days post transplant.

- Age: pediatrics and adults patients - 1 year old-75 years old.

- Karnofsky performance status >=60% for patients >16yo and Lansky performance status
>=60% for patients ≤16yo

- Stable blood counts (ANC>1000/uL, Hb>8gr/dL, Plt>50,000/ uL) not supported by
transfusions.

- Renal: Serum creatinine <1.5 ULN

- Hepatic: <3xULN ALT and <1.5 total serum bilirubin, unless there is congenital benign
hyperbilirubinemia.

- Cardiac: Adequate cardiac function measured by LVEF>50%. If asymptomatic,
pretransplant echocardiogram is adequate. If symptomatic, echocardiogram needs to be
repeated.

- Each patient must be willing to participate as a research subject and must sign an
informed consent form.

Exclusion Criteria:

Patients will be excluded from the trial if at time of enrollment:

- Active uncontrolled bacterial, fungal or viral infection.

- Evidence of uncontrolled graft-versus-host disease.

- Pulmonary: new onset hypoxia

- Known or suspected hypersensitivity to 5'-azacitadine or mannitol.

- Evidence of residual disease either by increased blasts count (>5%) or
persistence of previous known cytogenetics abnormalities.

- Peripheral blood neutrophil chimerism: less than 95% donor.
We found this trial at
6
sites
Basking Ridge, New Jersey 07920
Phone: 212-639-5987
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Commack, New York 11725
Phone: 212-639-5987
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500 Westchester Avenue
Harrison, New York 10604
Phone: 212-639-5987
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Middletown, New Jersey 07748
Phone: 212-639-5987
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Roni Tamari, MD
Phone: 212-639-5987
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Rockville Centre, New York 11570
Phone: 212-639-5987
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Rockville Centre, NY
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