Cyclophosphamide and Filgrastim Followed By SCT in Patients With Chronic or Accelerated Phase Myelogenous Leukemia
NCT ID: NCT00005984
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
22 participants
INTERVENTIONAL
2000-08-31
2005-09-30
Brief Summary
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PURPOSE: This phase II trial is studying how well cyclophosphamide plus filgrastim followed by stem cell transplant works in treating patients with chronic phase or accelerated phase chronic myelogenous leukemia.
Detailed Description
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* 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.
* 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.
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.
PROJECTED ACCRUAL: Not specified
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with CML
Patients treated for chronic accelerated phase and/or chronic myelogenous leukemia (CML)
cyclophosphamide
intravenously over 2 hours on day 1 and on days -7 and -6
filgrastim
filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover
recombinant interferon alfa
Beginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression
peripheral blood stem cell transplantation
Patients receive the PBSC transplantation on day 0.
radiation therapy
total body irradiation twice a day on days -4 through -1
Interventions
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cyclophosphamide
intravenously over 2 hours on day 1 and on days -7 and -6
filgrastim
filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover
recombinant interferon alfa
Beginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression
peripheral blood stem cell transplantation
Patients receive the PBSC transplantation on day 0.
radiation therapy
total body irradiation twice a day on days -4 through -1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Philadelphia chromosome positive OR
* BCR/ABL rearrangement
* Ineligible or refused to participate in ongoing allogeneic marrow donor transplant protocols
* 70 and under
* Performance status:
* Age 65-70 years:
* Karnofsky 80-100%
* Under 65 years:
* Karnofsky 90-100%
* 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
* Normal organ function (excluding bone marrow)
Exclusion Criteria
* Severe fibrosis defined by bilateral trephine biopsies
* Splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy
70 Years
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Masonic Cancer Center, University of Minnesota
Principal Investigators
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Catherine M. Verfaillie, MD
Role: STUDY_CHAIR
Masonic Cancer Center, University of Minnesota
Locations
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University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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UMN-MT-1996-11
Identifier Type: OTHER
Identifier Source: secondary_id
1996LS183
Identifier Type: -
Identifier Source: org_study_id