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

Phase 2CompletedNCT00774046

University of Chicago32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myelodysplastic Syndrome Acute Myeloid Leukemia

Interventions

Ara-CDRUG

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)

MitoxantroneDRUG

Induction: 30mg/m2 after the end of HiDAC day 1 and day 5

EtoposideDRUG

Mobilization: 30mg/kg over 6 doses given once every 12 hours for 3 days

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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

Time frame: Day 28-40

Overall Survival

Time frame: 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.

Time frame: Up to 2000 days

Secondary Outcomes

Feasibility of Stem Cell Collection

Feasibility is the ability to cryopreserve \>=2.0 x 10\^6 CD34+ cells/kg

Time frame: 1-5 days from initiation of stem cell collection

Numbers of Stem Cells Collected

Time frame: 1-5 days from initiation of stem cell collection

Overall Survival in Patients Undergoing Autologous Stem Cell Transplant

Time frame: Up to 817 days

Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant

Time frame: Up to 883 days

Data from ClinicalTrials.gov

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