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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00774046
First received: October 15, 2008
Last updated: January 16, 2014
Last verified: January 2014

October 15, 2008
January 16, 2014
December 2002
March 2011   (final data collection date for primary outcome measure)
  • Response to Induction Chemotherapy (CR or PR) [ Time Frame: Day 28-40 ] [ Designated as safety issue: No ]
    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
  • Overall Survival [ Time Frame: Up to 2000 days ] [ Designated as safety issue: No ]
  • Relapse-free Survival [ Time Frame: Up to 2000 days ] [ Designated as safety issue: No ]
    Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.
-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 ]
Complete list of historical versions of study NCT00774046 on ClinicalTrials.gov Archive Site
  • Feasibility of Stem Cell Collection [ Time Frame: 1-5 days from initiation of stem cell collection ] [ Designated as safety issue: No ]
    Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg
  • Numbers of Stem Cells Collected [ Time Frame: 1-5 days from initiation of stem cell collection ] [ Designated as safety issue: No ]
  • Overall Survival in Patients Undergoing Autologous Stem Cell Transplant [ Time Frame: Up to 817 days ] [ Designated as safety issue: No ]
  • Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant [ Time Frame: Up to 883 days ] [ Designated as safety issue: No ]
-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 ]
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
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
Experimental: Induction chemotherapy followed by stem cell transplant
Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
Interventions:
  • Drug: Ara-C
  • Drug: Mitoxantrone
  • Drug: Etoposide
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
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Lucy Godley, M.D. University of Chicago
University of Chicago
January 2014

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