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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2023-09-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Myelodysplastic Syndromes (MDS) Acute Myelogenous Leukemia (AML)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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low dose 5'-azacitidine

This is a single arm phase II trial to assess the efficacy and confirm the safety of maintenance therapy with 5'-azacitadine compared to historical control after TCD allogeneic hematopoietic stem cell transplant for patients with MDS and AML who are at high risk of relapse.

Group Type EXPERIMENTAL

low dose 5'-azacitidine

Intervention Type DRUG

5'-azacitadine will be given at a low dose of 32mg/m2 S.C for 5 days every 28 days (a cycle). Dose de-escalation will be permitted for hematologic and non- hematologic toxicities. Patients will start taking the study drug between days 60-120 post TCD allogeneic hematopoietic stem cell transplant and up to a year post-transplant or until there is a toxicity that requires cessation of therapy. Therefore patients will get between 8-10 cycles. Patients who come off-study for reasons unrelated to toxicities before completing 4 cycles will be replaced Since most cases of relapse occur early post transplant, in the first year, this is the most appropriate time to intervene. Treatment will start as soon as possible.

Interventions

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low dose 5'-azacitidine

5'-azacitadine will be given at a low dose of 32mg/m2 S.C for 5 days every 28 days (a cycle). Dose de-escalation will be permitted for hematologic and non- hematologic toxicities. Patients will start taking the study drug between days 60-120 post TCD allogeneic hematopoietic stem cell transplant and up to a year post-transplant or until there is a toxicity that requires cessation of therapy. Therefore patients will get between 8-10 cycles. Patients who come off-study for reasons unrelated to toxicities before completing 4 cycles will be replaced Since most cases of relapse occur early post transplant, in the first year, this is the most appropriate time to intervene. Treatment will start as soon as possible.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No