Autotransplantation for Chronic Myelogenous Leukemia (CML) Followed by Immunotherapy With Ex-Vivo Expanded Autologous T Cells
OBJECTIVES:
- Determine the feasibility of ex vivo expansion and reinfusion of autologous CD4+ T
cells after interferon therapy or high-dose chemotherapy with CD34-selected autologous
peripheral blood stem cell rescue in patients with chronic phase chronic myelogenous
leukemia (CML).
- Determine the frequency of hematologic, cytogenetic, and molecular remissions of CML
following infusion of ex vivo expanded T cells.
OUTLINE: Patients undergo mononuclear cell leukapheresis to obtain T cells for ex-vivo
expansion, preferably before they receive interferon alfa subcutaneously (SC) daily on a
therapeutic trial.
At least 1 month after interferon is stopped, mobilization chemotherapy is administered.
Patients receive cyclophosphamide IV over 12 hours on day 0, etoposide IV over 2 hours on
day 1, sargramostim (GM-CSF) SC on days 3 and 4, and filgrastim (G-CSF) SC beginning on day
5. Peripheral blood stem cells (PBSC) are collected by leukapheresis when blood cell counts
have recovered.
Approximately 2-3 weeks later, high-dose chemotherapy begins. Patients receive gemcitabine
IV over 100 minutes on day -5, carmustine IV over 2 hours on day -2, followed 6 hours later
by gemcitabine IV again, and melphalan IV over 20 minutes on day -1. CD34 selected PBSCs are
infused on day 0, at least 18 hours after melphalan administration. Patients receive GM-CSF
SC beginning on day 1 and continuing until blood cell counts recover.
Patients then receive ex vivo expanded autologous T cells on day 14 after
autotransplantation. Interferon alfa is administered three times a week starting about 3
months after transplantation.
Patients who only receive expanded T cells, without high-dose chemotherapy and
autotransplantation, but show no response after 3 months, may proceed to autotransplantation
followed by a second ex vivo expanded T-cell infusion.
Patients are followed at 1, 2, 3, 6, 9, and 12 months, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 7-22 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Response (i.e., major cytogenetic or molecular response) within 12 months after completion of study therapy
No
Aaron P. Rapoport, MD
Study Chair
University of Maryland Greenebaum Cancer Center
United States: Food and Drug Administration
CDR0000066839
NCT00003727
March 1999
February 2008
Name | Location |
---|---|
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |