Chemotherapy, Filgrastim and Peripheral Stem Cell Transplantation in Patients With Chronic Myelogenous Leukemia
NCT ID: NCT00005986
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
INTERVENTIONAL
2000-08-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of chemotherapy and filgrastim followed by peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia.
Detailed Description
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* Assess clinical outcomes, survival, and morbidity of transplantation therapy in patients with chronic myelogenous leukemia when treated with high dose chemotherapy and filgrastim (G-CSF) followed by autologous retrovirally transduced peripheral blood stem cell (PBSC) transplantation.
* Determine whether this priming treatment can increase the fraction of benign Philadelphia chromosome (Ph) negative hematopoietic progenitors in PBSC and reduce the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients.
* Assess whether retroviral transduction of mobilized PBSC progenitors determines the contribution of malignant Ph positive progenitors contaminating the graft to relapse after transplantation in these patients.
* Determine whether this priming treatment can expand the benign progenitor population in the PBSC collections from these patients.
OUTLINE: In the priming phase, patients receive cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SQ) daily beginning on day 4 and continuing until the completion of leukapheresis. Peripheral blood stem cells (PBSC) are harvested 4-7 times between days 10 and 21 beginning when blood counts recover (CD34+ cells are selected from 2 of these PBSC collections and transduced with the LN NEO virus prior to cryopreservation).
In the transplant phase, patients who have not received prior radiotherapy receive cyclophosphamide IV over 2 hours daily on days -7 and -6 and total body irradiation on days -4 through -1. Autologous PBSC and LN NEO transduced CD34+ cells are reinfused on day 0. Patients also receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover.
Patients who have received prior radiotherapy receive oral busulfan every 6 hours on days -10 through -7 and cyclophosphamide IV daily on days -6 through -3. Autologous PBSC and LN NEO transduced CD34+ cells are reinfused on day 0. Patients also receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover.
All patients then receive interferon alfa SQ daily until disease progression or unacceptable toxicity.
Patients are followed at 3 weeks; at 3, 6, 9, 12, 18, and 24 months; and then annually thereafter.
PROJECTED ACCRUAL: A total of 4-26 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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busulfan
cyclophosphamide
filgrastim
recombinant interferon alfa
in vitro-treated peripheral blood stem cell transplantation
peripheral blood stem cell transplantation
radiation therapy
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS:
Age:
* 18 to 65
Performance status:
* Karnofsky 90-100%
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Normal organ function (except bone marrow)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior interferon alfa allowed
Chemotherapy:
* Prior hydroxyurea allowed
* At least 2 months since prior busulfan (at time of PBSC harvest)
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
18 Years
65 Years
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
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-9507
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000067974
Identifier Type: -
Identifier Source: org_study_id