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Home > "A" Clinical Trials Conditions > Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia  Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
For Condition: stage 2 chronic lymphocytic leukemia,B-cell Chronic Lymphocytic Leukemia,stage 3 chronic lymphocytic leukemia,stage 1 chronic lymphocytic leukemia,stage 4 chronic lymphocytic leukemia
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Combining monoclonal antibody therapy, chemotherapy, radiation therapy, and peripheral stem cell transplantation may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of alemtuzumab plus peripheral stem cell transplantation in treating patients who have chronic lymphocytic leukemia.
Details: OBJECTIVES: - Determine the ability of in vivo purging with alemtuzumab (monoclonal antibody CD52; Campath-1H) to produce a stem cell graft without detectable leukemia cells in patients with chronic lymphocytic leukemia. - Determine the ability to successfully mobilize stem cells after in vivo purging with monoclonal antibody CD52 in these patients. - Determine the toxicity of this treatment regimen in these patients. - Determine the response to this treatment regimen in these patients at 6 months after peripheral blood stem cell transplantation. OUTLINE: This is a multicenter study. Patients receive induction therapy comprising alemtuzumab (monoclonal antibody CD52; Campath-1H) IV over 2 hours three times a week for 4 weeks. Beginning no more than 2 weeks after induction therapy, patients receive mobilization chemotherapy comprising cyclophosphamide IV over 1-2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) starting on day 2 and continuing until the last day of apheresis. Patients undergo peripheral blood stem cell apheresis on days 10-14. Beginning 2-4 weeks after apheresis, patients receive a preparative regimen comprising cyclophosphamide IV over 2 hours on days -5 and -4 and fractionated total body irradiation twice a day over 6-10 hours on days -3 to -1. Patients undergo peripheral blood stem cell transplantation on day 0. Patients receive G-CSF SC beginning on day 1 and continuing until blood counts recover. Patients are followed at 60 days, 1 year, and then annually thereafter until disease progression. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of chronic lymphocytic leukemia (CLL) that meets the following criteria at any point prior to study entry: - Peripheral blood absolute blood count greater than 5,000/mm^3 - Lymphocytosis must comprise small to moderate size lymphocytes with no more than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically - Phenotypically characterized B-cell CLL - Splenomegaly, hepatomegaly, or lymphadenopathy not required for CLL diagnosis - Must have bone marrow biopsy within 4 weeks of study entry showing cellularity of at least 25% of intratrabecular space and lymphocytes accounting for no more than 30% of nucleated cells PATIENT CHARACTERISTICS: Age: - 18 to 65 Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - Absolute neutrophil count at least 1,000/mm^3 - Hemoglobin at least 11 g/dL - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2 mg/dL (unless secondary to tumor) - AST or ALT less than 3 times upper limit of normal - Hepatitis B surface antigen negative - Hepatitis C RNA negative Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - Left ventricular ejection fraction at least 45% by echocardiogram or MUGA Pulmonary: - DLCO, FEV_1, and FVC greater than 50% of predicted Other: - No active infection requiring oral or IV antibiotics - No other prior malignancy within the past two years except basal cell skin cancer or carcinoma in situ of the cervix - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior monoclonal antibody CD52 allowed if at least partial remission was achieved with last treatment Chemotherapy: - No more than 2 prior chemotherapy regimens - At least 3 weeks since prior chemotherapy - No more than 8 courses of prior fludarabine therapy Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IanFlinn, Study Chair, Sidney Kimmel Cancer Center
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago, Illinois, 60611-4494
United States
Recruiting Timothy Kuzel 312-469-3748
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Witold Rybka 717-531-1050
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Daniel Haller 215-662-6318
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Lori Goldstein 215-728-2689
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5917
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting James Stewart 608-265-8131
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Ian Flinn 410-614-5542
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15236
United States
Recruiting John Kirkwood 412-692-4724
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Michael Atkins 617-667-1930
Additional Information:
Study ID Numbers: CDR0000068272; ECOG-8998
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006390
Other Stage 1 Chronic Lymphocytic Leukemia Studies:
1. Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia
2. Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia
3. LMB-2 Immunotoxin in Treating Patients With Chronic Lymphocytic Leukemia
4. Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
5. Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia
Related Studies:
Other stage 1 chronic lymphocytic leukemia Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
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