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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lucy Godley, University of Chicago
ClinicalTrials.gov Identifier:
NCT00774046
First received: October 15, 2008
Last updated: September 5, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Myelodysplastic Syndrome
Acute Myeloid Leukemia
 Drug: Ara-C
Drug: Mitoxantrone
Drug: Etoposide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for Therapy-Related Myelodysplastic Syndrome/Therapy -Related Acute Myeloid Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • -remission induction rate, toxicities, relapse-free survival, and overall survival of patients after a standardized induction regimen of high-dose cytarabine and mitoxantrone [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • -the feasibility, numbers of stem cell collected, toxicities of mobilization chemotherapy and autotransplantation, relapse-free survival, and overall survival of patients after they have undergone autologous stem cell transplant. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: December 2002
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ara-C

    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)

    Other Names:
    • Cytarabine
    • HiDAC
    Drug: Mitoxantrone
    Induction: 30mg/m2 after the end of HiDAC day 1 and day 5
    Drug: Etoposide
    Mobilization: 30mg/kg over 6 doses given once every 12 hours for 3 days
    Other Name: VP-16
  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774046

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Lucy Godley, M.D. University of Chicago
  More Information

No publications provided

Responsible Party: Lucy Godley, Associate Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT00774046     History of Changes
Other Study ID Numbers: 11884A
Study First Received: October 15, 2008
Last Updated: September 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Therapy-related myelodysplastic syndrome/ Therapy -related Acute myeloid leukemia
Myelodysplastic syndrome
Acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Cytarabine
Etoposide
Mitoxantrone
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013