Ex Vivo Expansion of Mafosfamide Purged CD34+ Cells in Patients With Acute Leukemia

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected. Treating stem cells collected from the patient's blood or bone marrow with chemotherapy in the laboratory removes any remaining cancer cells. Chemotherapy or radiation therapy is given to the patient to prepare the bone marrow for stem cell transplant. The treated stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This clinical trial is studying how well an autologous peripheral stem cell or bone marrow transplant using laboratory-treated cells works in treating patients with acute leukemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Cyclophosphamide

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of acute leukemia meeting 1 of the following criteria:

• High-risk acute myeloid leukemia (AML) in first complete remission (CR) with no matched family donor available, including any of the following types:

• Secondary AML

• AML with chromosome 5 or 7 abnormalities

• AML with trisomy 8

• AML with 6;9 chromosomal translocation

• AML with 11q23 chromosomal abnormality

• AML with multiple or complex chromosomal abnormalities

• AML with FAB M6 or M7

• AML in second CR (CR2) with no eligible HLA-identical sibling donor available

• High-risk acute lymphoblastic leukemia (ALL) with no eligible HLA-identical sibling donor available, including any of the following types:

• Philadelphia chromosome-positive ALL

• ALL with 11q23 chromosomal abnormality

• ALL in CR2

• Eligible for and willing to undergo bone marrow transplantation

• No intermediate- or good-risk acute leukemia in CR1

Exclusion Criteria

• Availability of a suitable matched HLA-identical sibling marrow donor

• Intermediate or good risk acute leukemia in CR1 (39)

• Age greater than 70

• Weight less than 10 kg

• Any risk of pregnancy - all female patients must have an effective form of contraception or be infertile due to hysterectomy, fallopian tube, surgery or premature menopause.

• HIV Infection: Patients must be HIV negative for inclusion.

• Poor organ function as defined in the BMT Policies and Procedures Manual.