Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia
Intervention: busulfan (Drug); cyclophosphamide (Drug); cyclosporine (Drug); cytarabine (Drug); filgrastim (Drug); idarubicin (Drug); recombinant interferon gamma (Drug); chemotherapy (Procedure); colony-stimulating factor therapy (Procedure); graft-versus-tumor induction therapy (Procedure); interferon therapy (Procedure); peripheral blood stem cell transplantation (Procedure)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
Official(s) and/or principal investigator(s):
Gwen L. Nichols, MD, Study Chair, Affiliation: Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by
peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia.
Official title: 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
Study design: Treatment
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
Minimum age: 18 Years.
Maximum age: 60 Years.
DISEASE CHARACTERISTICS: Diagnosis of chronic myelogenous leukemia in first chronic phase
Philadelphia chromosome-positive Myelofibrosis less than 3+ on bone marrow biopsy
Ineligible for allogeneic transplantation No suitable allogeneic sibling donor OR Under 55
years old but refuses unrelated donor transplantation or no unrelated donor
PATIENT CHARACTERISTICS: Age: 18 to physiologic 60 Performance status: ECOG 0-1
Hematopoietic: See Disease Characteristics WBC at least 3,000/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 2 times normal (unless elevation due to Gilbert's
disease) SGOT less than 1. 5 times normal Renal: Creatinine less than 1. 5 times normal
Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: DLCO at least
60% predicted Other: HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior interferon alfa
Chemotherapy: No concurrent conventional chemotherapy Endocrine therapy: No concurrent
steroids during chemotherapy Radiotherapy: Not specified Surgery: Not specified Other: No
concurrent barbiturates or acetaminophen during chemotherapy
Locations and Contacts
Herbert Irving Comprehensive Cancer Center, New York, New York 10032, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
Papadopoulos KP, Nichols G: Autologous peripheral blood progenitor (PBPC) transplantation in patients with chronic myeloid leukemia. Biol Blood Marrow Transplant 4(2): A-55, 109, 1998.
Starting date: February 1996
Last updated: December 15, 2007