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Completed

NCT Number: NCT00774046

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

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

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Key information

Conditions

Myelodysplastic Syndrome Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ara-C

Drug

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

Mitoxantrone

Drug

Induction: 30mg/m2 after the end of HiDAC day 1 and day 5

etoposide

Drug

Mobilization: 30mg/kg over 6 doses given once every 12 hours for 3 days

Other names: VP-16

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for Therapy-Related Myelodysplastic Syndrome/Therapy -Related Acute Myeloid Leukemia

Important dates

Study start
2002
Primary completion
2011
Study completion
2011
First posted
Oct 16, 2008
Registry last updated
Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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