Status:
TERMINATED
Ex Vivo Expansion of Mafosfamide Purged CD34+ Cells in Patients With Acute Leukemia
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE1
Brief 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 colle...
Detailed Description
OBJECTIVES: * Determine the feasibility of ex vivo expanded mafosfamide-purged CD34-positive cells for autologous peripheral blood stem cell or bone marrow transplantation in patients with acute leuk...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00245115
Start Date
October 1 2005
End Date
January 1 2012
Last Update
August 23 2018
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231