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


Phase 2
10 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome, Acute Myeloid Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to Induction Chemotherapy (CR or PR)

Outcome Description:

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

Outcome Time Frame:

Day 28-40

Safety Issue:

No

Principal Investigator

Lucy Godley, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Institutional Review Board

Study ID:

11884A

NCT ID:

NCT00774046

Start Date:

December 2002

Completion Date:

March 2011

Related Keywords:

  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia
  • Therapy-related myelodysplastic syndrome/ Therapy -related Acute myeloid leukemia
  • Myelodysplastic syndrome
  • Acute myeloid leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

The University of ChicagoChicago, Illinois  60637