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

Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myelodysplastic Syndrome; Acute Myeloid Leukemia

Intervention: Ara-C (Drug); Mitoxantrone (Drug); Etoposide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Lucy Godley, M.D., Principal Investigator, Affiliation: University of Chicago


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

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Response to Induction Chemotherapy (CR or PR)

Overall Survival

Relapse-free Survival

Secondary outcome:

Feasibility of Stem Cell Collection

Numbers of Stem Cells Collected

Overall Survival in Patients Undergoing Autologous Stem Cell Transplant

Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant


Minimum age: 10 Years. Maximum age: N/A. Gender(s): Both.


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


Locations and Contacts

The University of Chicago, Chicago, Illinois 60637, United States
Additional Information

Starting date: December 2002
Last updated: January 16, 2014

Page last updated: August 23, 2015

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