- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005984
Cyclophosphamide and Filgrastim Followed By SCT in Patients With Chronic or Accelerated Phase Myelogenous Leukemia
Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming
RATIONALE: Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.
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.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- 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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia (CML)
- 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:
- Blast crisis or post blast crisis
- Severe fibrosis defined by bilateral trephine biopsies
- Splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with CML
Patients treated for chronic accelerated phase and/or chronic myelogenous leukemia (CML)
|
intravenously over 2 hours on day 1 and on days -7 and -6
Other Names:
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
Other Names:
Beginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression
Other Names:
Patients receive the PBSC transplantation on day 0.
Other Names:
total body irradiation twice a day on days -4 through -1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Time to hemopoietic recovery after transplantation
|
Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples
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Secondary Outcome Measures
Outcome Measure |
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Cause of death
|
Time to initial hospital discharge
|
Peritransplantation toxicity
|
Quality of life at various time points
|
Collaborators and Investigators
Investigators
- Study Chair: Catherine M. Verfaillie, MD, Masonic Cancer Center, University of Minnesota
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Interferons
- Interferon-alpha
- Cyclophosphamide
Other Study ID Numbers
- 1996LS183
- UMN-MT-1996-11 (Other Identifier: Blood and Marrow Transplantation Program)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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