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

Stopped early · Phase 1

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT00245115

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

7

Starts

2005-10-01

Expected to finish

2012-01-01

Last updated by the study team

2018-08-23

Who can join

Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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