Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia

Basic Trial Information

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.

Entry Criteria

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 available

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  
  

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

Expected Enrollment

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

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.

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.

Trial Contact Information

Trial Lead Organizations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Gwen Nichols, MD, Protocol chair		Ph: 212-305-5705 Email: nichols@columbia.edu

Registry Information
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
Trial Start Date		1996-02-23
Trial Completion Date		2007-02-01
Registered in ClinicalTrials.gov		NCT00002761
Date Submitted to PDQ		1996-02-23
Information Last Verified		2008-05-22
NCI Grant/Contract Number		CA13696

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