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
  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: 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:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

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)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: University of Chicago
ClinicalTrials.gov Identifier: NCT00774046     History of Changes
Other Study ID Numbers: 11884A
Study First Received: October 15, 2008
Results First Received: December 17, 2012
Last Updated: January 16, 2014
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 phosphate
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
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Analgesics

ClinicalTrials.gov processed this record on August 01, 2014