Finding studies
Finding studies
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Lead
M.D. Anderson Cancer Center
With
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of gemcitabine when administered with busulfan and clofarabine. II. To estimate the day 100 treatment-related mortality (TRM) for the preparative regimen busulfan, clofarabine, and gemcitabine followed by allogeneic hematopoietic cell transplantation (HCT) for patients with chronic lymphocytic leukemia (CLL). SECONDARY OBJECTIVES: I. To determine the rate of progression-free survival (PFS), graft versus host disease (GVHD), engraftment, and overall survival (OS) for this treatment regimen at one year post treatment completion. OUTLINE: This is a dose-escalation study of gemcitabine. Participants receive gemcitabine intravenously (IV) over 10-25 minutes on days -6 and -4, clofarabine IV over 1 hour and busulfan IV over 3 hours on days -6 to -3. Participants with matched unrelated donors also receive anti-thymocyte globulin IV over 4 hours on days -3 to -1. Starting day -2, participants receive tacrolimus orally (PO) daily for up to 6 months. Participants undergo hematopoietic allogeneic stem cell transplant on day 0, then receive methotrexate IV over 15 minutes on days 1, 3, 6 and 11, and filgrastim subcutaneously (SC) once daily (QD) beginning 1 week after transplant until blood cell levels return to normal. After completion of study treatment, participants are followed up at 3, 6 and 12 months, then every 6 months for 1 year.
Age
18–70
Sex
ALL
Healthy volunteers
Accepted
