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

Alternate Title

Cyclophosphamide and Filgrastim Followed By Stem Cell Transplant in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 70 and under Other UMN-MT-9611 UMN-MT-1996-11, NCT00005984

Objectives

1. Assess the clinical outcomes, survival, and morbidity of patients with chronic or accelerated phase chronic myelogenous leukemia when treated with cyclophosphamide and filgrastim (G-CSF) followed by autologous peripheral blood stem cell transplantation.
2. Determine whether priming with cyclophosphamide and filgrastim (G-CSF) increases the fraction of benign Philadelphia chromosome negative hematopoietic progenitors in peripheral blood stem cells (PBSC) and reduces the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia (CML)
  • Philadelphia chromosome positive OR
  • BCR/ABL rearrangement



• No blast crisis or post blast crisis



• No severe fibrosis defined by bilateral trephine biopsies



• No splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy



• Ineligible or refused to participate in ongoing allogeneic marrow donor transplant protocols

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• Not specified

Patient Characteristics:

Age:

• 70 and under

Performance status:

• Age 65-70 years:
  • Karnofsky 80-100%
• Under 65 years:
  • Karnofsky 90-100%

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Age 65-70 years:
  • Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)
• Under 65 years:
  • Not specified

Cardiovascular:

• Age 65-70 years:
  • LVEF at least 45%

Pulmonary:

• Age 65-70 years:
  • If history of smoking or respiratory symptoms, spirometry and DLCO must be greater then 50% of predicted

Other:

• Normal organ function (excluding bone marrow)

Expected Enrollment

Not specified

Outcomes

Time to hemopoietic recovery after transplantation
Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples

Time to initial hospital discharge
Peritransplantation toxicity
Quality of life at various time points
Cause of death

Outline

Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected between days 14-21.

Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1. Patients receive the PBSC transplantation on day 0. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover. Patients then receive interferon alfa SQ daily in the absence of unacceptable toxicity or disease progression.

Patients are followed at 3 weeks; then at 3, 6, 9, 12, and 18 months; and then annually for 5 years.

Trial Contact Information

Trial Lead Organizations

Masonic Cancer Center at University of Minnesota

Catherine Verfaillie, MD, Protocol chair		Ph: 612-625-0602; 888-226-2376

Registry Information
Official Title		Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming
Trial Start Date		2000-08-07
Registered in ClinicalTrials.gov		NCT00005984
Date Submitted to PDQ		2000-05-04
Information Last Verified		2006-04-06
NCI Grant/Contract Number		CA77598

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