High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.

Official Title
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High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for Therapy-Related Myelodysplastic Syndrome/Therapy -Related Acute Myeloid Leukemia

Conditions
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Myelodysplastic Syndrome, Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Ara-C
* Drug: Mitoxantrone
* Drug: Etoposide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have received cytotoxic chemotherapy,radiation,or a drug known to affect the properties of DNA or cell growth for some condition other than acute myeloid leukemia prior to diagnosis. Patients must have t-MDS/t-AML To be eligible for allogeneic transplantation, patients must have a suitable donor who is HLA compatible. Patients must be over the age of 10. Patients must be reviewed and discussed at the Leukemia and Transplant Conferences of the Section of Hematology/Oncology. Exclusion Criteria: Patients must not have any other serious medical condition(e.g.uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection) Psychiatric condition which would prevent compliance or possibly be worsened by treatment

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Induction chemotherapy followed by stem cell transplant<br>Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant | Drug: Ara-C<br>* Induction: 3000mg/m2 IV infusion for day 1 and day 5 Mobilization: within 2 weeks of end of induction therapy - 2000mg/m2 as 2 hour IV infusion once every 12 hours for 3 days (6 doses total)<br>* Other names: HiDAC;Drug: Mitoxantrone<br>* Induction: 30mg/m2 after the end of HiDAC day 1 and day 5<br>Drug: Etoposide<br>* Mobilization: 30mg/kg over 6 doses given once every 12 hours for 3 days<br>* Other names: VP-16;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to Induction Chemotherapy (CR or PR) | Complete remission (CR): <5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): >5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made | Day 28-40 | 
| Overall Survival |  | Up to 2000 days | 
| Relapse-free Survival | Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality. | Up to 2000 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Stem Cell Collection | Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg | 1-5 days from initiation of stem cell collection | 
| Numbers of Stem Cells Collected |  | 1-5 days from initiation of stem cell collection | 
| Overall Survival in Patients Undergoing Autologous Stem Cell Transplant |  | Up to 817 days | 
| Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant |  | Up to 883 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapy-related myelodysplastic syndrome/ Therapy -related Acute myeloid leukemia, Myelodysplastic syndrome, Acute myeloid leukemia