Trial Information

CAMP-010: PHASE I/II STUDY OF IN VIVO PURGING FOLLOWED BY HIGH DOSE CHEMOTHERAPY, AUTOLOGOUS HEMATOPOIETIC STEM CELL INFUSION AND IMMUNOTHERAPY IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA

OBJECTIVES: I. Determine whether intensive idarubicin and cytarabine leads to adequate
harvest of Philadelphia chromosome-negative peripheral blood stem cells (PBSC) in patients
with chronic myelogenous leukemia in chronic phase. II. Determine the toxicity of this
intensive regimen in these patients. III. Determine the graft-versus-leukemia effect induced
in these patients by cyclosporine and interferon gamma post-PBSC transplantation. IV.
Determine the transformation-free and overall survival in patients treated with a high-dose
conditioning regimen comprising busulfan and cyclophosphamide followed by PBSC
transplantation plus immunotherapy.

OUTLINE: Patients receive idarubicin IV and cytarabine IV over 2 hours on days 1-3. When
blood counts recover, Philadelphia chromosome negative peripheral blood stem cells (PBSC)
are harvested. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning 24 hours
after completion of cytarabine infusion and continuing until blood counts have recovered for
3 consecutive days after harvest of PBSC. Patients with more than 5% blasts in marrow or any
peripheral blasts, interferon resistance, interferon intolerance with poor prognosis, and
clonal evolution proceed to conditioning followed by PBSC transplantation. Patients receive
conditioning comprising oral busulfan every 6 hrs on days -8 to -5 and cyclophosphamide IV
over 2 hours on days -4 and -3. PBSC are reinfused on day 0. Patients receive graft versus
leukemia induction comprising cyclosporine IV over 4 hours every 12 hours on days 0-28 and
interferon gamma SC beginning on day 7 and continuing every other day through day 28.
Patients are followed every 3 months for 1 year and then annually for 5 years.

PROJECTED ACCRUAL: A total of 15-43 patients will be accrued for this study within 4-8
years.