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

The University of Chicago

Status and phase: Completed; Phase 2

Conditions: Myelodysplastic Syndrome; Acute Myeloid Leukemia

Treatments: Drug: Etoposide; Drug: Mitoxantrone; Drug: Ara-C

Study type: Interventional

Funder types: Other

Identifiers

NCT00774046

11884A

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 1 patient group

Induction chemotherapy followed by stem cell transplant

Experimental group

Description:

Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant

Treatment:

Drug: Ara-C

Drug: Etoposide

Drug: Mitoxantrone