A PILOT STUDY OF TOTAL BODY IRRADIATION AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS TRANSPLANTATION WITH CD34 SELECTED PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
filgrastim
+ cyclophosphamide
+ dexamethasone
Chronic Disease+13
+ Hematologic Diseases
+ Hemic and Lymphatic Diseases
Treatment Study
Summary
Study start date: October 1, 1995
Actual date on which the first participant was enrolled.OBJECTIVES: I. Evaluate engraftment after autografting with CD34 selected peripheral blood stem cells (PBSC) in patients with chronic lymphocytic leukemia (CLL). II. Evaluate the efficacy of CD34 selection for purging CLL from PBSC collection. III. Determine the effectiveness of mobilization chemotherapy with cyclophosphamide, etoposide, and dexamethasone plus filgrastim (granulocyte colony-stimulating factor) to mobilize PBSC in these patients. IV. Describe toxicity and disease response to a conditioning regimen of total body irradiation and cyclophosphamide in these patients. OUTLINE: There are 3 phases to the treatment plan: Cytoreductive chemotherapy can be given by conventional chemotherapy. Patients are treated until at least a good partial remission. Patients will have CD34 selected peripheral blood stem cells (PBSC) stored after treatment with mobilization chemotherapy followed by filgrastim (granulocyte colony-stimulating factor; G-CSF). Cyclosphosphamide (CTX) IV is given over 1 hour. Etoposide (VP-16) is given over 1-2 hours on day 2. Dexamethasone is given 4 times a day on days 1-3. G-CSF is given subcutaneously daily beginning 2 days after chemotherapy and continuing until PBSC collection is completed. At least 4 weeks should ensue after mobilization chemotherapy before proceeding with the transplant. Patients are treated with TBI on days -6, -5, and -4 and CTX on days -3 and -2. PBSC are infused on day 0. PROJECTED ACCRUAL: A total of 15 patients will be entered in this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 17 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Diagnostically proven intermediate, advanced, or high risk chronic lymphocytic leukemia of the B cells with marrow tumor reduced by prior therapy Marrow tumor content no greater than 30% of total nucleated cells Patients age 50 and under who have high risk disease are eligible Patients age 65 and under who have intermediate or high risk disease that has failed at least 1 therapy including an alkylating agent or fludarabine are eligible No history of transformation to aggressive lymphoma (Richter's syndrome) PATIENT CHARACTERISTICS: Age: 17 to 65 Performance status: Karnofsky 70%-100% Life expectancy: Not severely limited by illness other than leukemia Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 (no growth factor support) Platelet count greater than 120,000/mm3 (unless documented active autoimmune thrombocytopenia) Hemoglobin greater than 10 g/dL (unless documented active autoimmune anemia) No coexisting myelodysplasia Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine clearance at least 50 mL/min Cardiovascular: No cardiac disease that would limit ability to receive cytoreductive therapy and compromise survival Pulmonary: No pulmonary disease that would limit ability to receive cytoreductive therapy and compromise survival Other: No HIV antibody Not pregnant PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior radiation therapy to chest or abdomen greater than 2,000 Gy
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fred Hutchinson Cancer Research Center
Seattle, United StatesOpen Fred Hutchinson Cancer Research Center in Google Maps