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Cyclophosphamide and Filgrastim Followed By Peripheral Stem Cell Transplantation in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Cyclophosphamide and Filgrastim Followed By Peripheral Stem Cell Transplantation in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Cyclophosphamide and Filgrastim Followed By Peripheral Stem Cell Transplantation in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia Clinical research trials and Cyclophosphamide and Filgrastim Followed By Peripheral Stem Cell Transplantation in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Cyclophosphamide and Filgrastim Followed By Peripheral Stem Cell Transplantation in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia. Cyclophosphamide and Filgrastim Followed By Peripheral Stem Cell Transplantation in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Cyclophosphamide and Filgrastim Followed By Peripheral Stem Cell Transplantation in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia clinical trial. Participants oftentimes recieve the most expert healthcare available for their Cyclophosphamide and Filgrastim Followed By Peripheral Stem Cell Transplantation in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.

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



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

For Condition: chronic phase chronic myelogenous leukemia,childhood chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia,accelerated phase chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): University of Minnesota Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide plus filgrastim followed by autologous peripheral stem cell transplantation in treating patients who have chronic phase or accelerated phasechronic myelogenous leukemia.
Details: 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
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /70 Years
Genders: Both
Protocol 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 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) PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics Surgery: - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CatherineVerfaillie,  Study Chair,  University of Minnesota Cancer Center

University of Minnesota Cancer Center *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting Catherine  Verfaillie 612-624-3921


Additional Information:
Study ID Numbers:  CDR0000067972;  UMN-MT-9611,UMN-MT-1996-11
Study Start Date: 
Record last reviewed: May 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005984

Other Chronic Phase Chronic Myelogenous Leukemia Studies:
1. Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia

2. Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma

3. Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase

4. Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia

5. BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate

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