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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00774046
Recruitment Status : Completed
First Posted : October 16, 2008
Results First Posted : June 24, 2013
Last Update Posted : February 11, 2014
Information provided by (Responsible Party):
University of Chicago

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for Therapy-Related Myelodysplastic Syndrome/Therapy -Related Acute Myeloid Leukemia
Study Start Date : December 2002
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: Induction chemotherapy followed by stem cell transplant
Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
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

Primary Outcome Measures :
  1. Response to Induction Chemotherapy (CR or PR) [ Time Frame: Day 28-40 ]
    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

  2. Overall Survival [ Time Frame: Up to 2000 days ]
  3. Relapse-free Survival [ Time Frame: Up to 2000 days ]
    Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.

Secondary Outcome Measures :
  1. Feasibility of Stem Cell Collection [ Time Frame: 1-5 days from initiation of stem cell collection ]
    Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg

  2. Numbers of Stem Cells Collected [ Time Frame: 1-5 days from initiation of stem cell collection ]
  3. Overall Survival in Patients Undergoing Autologous Stem Cell Transplant [ Time Frame: Up to 817 days ]
  4. Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant [ Time Frame: Up to 883 days ]

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00774046

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

Responsible Party: University of Chicago Identifier: NCT00774046     History of Changes
Other Study ID Numbers: 11884A
First Posted: October 16, 2008    Key Record Dates
Results First Posted: June 24, 2013
Last Update Posted: February 11, 2014
Last Verified: January 2014

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, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs