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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

October 15, 2008
September 5, 2012
December 2002
March 2011   (final data collection date for primary outcome measure)
-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 ]
Same as current
Complete list of historical versions of study NCT00774046 on ClinicalTrials.gov Archive Site
-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 ]
Same as current
Not Provided
Not Provided
 
High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML
High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for Therapy-Related Myelodysplastic Syndrome/Therapy -Related Acute Myeloid Leukemia

The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00774046
11884A
Yes
Lucy Godley, University of Chicago
University of Chicago
Not Provided
Principal Investigator: Lucy Godley, M.D. University of Chicago
University of Chicago
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP