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Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia Clinical research trials and Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia. Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia clinical trial. Subjects frequently obtain the most expert healthcare possible for their Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia  Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
For Condition: B-cell Chronic Lymphocytic Leukemia,refractory chronic lymphocytic leukemia
Status: Not yet recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab and alemtuzumab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase II trial to determine the effectiveness of combining pentostatin and cyclophosphamide with rituximab followed by alemtuzumab in treating patients who have relapsed or refractoryB-cellchronic lymphocytic leukemia.
Details: OBJECTIVES: Primary - Determine the objective response rate (complete remission, partial remission [PR], or nodular PR) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL) treated with pentostatin, cyclophosphamide, and rituximab (PCR) followed by alemtuzumab. - Determine the presence of minimal residual disease in patients treated with this regimen. Secondary - Determine the toxicity of this regimen in these patients. - Determine the overall and progression-free survival of patients treated with this regimen. - Determine the number of patients who, after PCR, only achieve PR, stable disease, or progressive disease and subsequently convert to a higher response category after alemtuzumab. - Correlate V_H gene mutation status and CD38 expression of the CLL B-cell clones with clinical outcome in patients treated with this regimen. - Correlate the differential expression of genes in the leukemic cells with clinical outcome in patients treated with this regimen. - Correlate surface phenotype and genetic defects of the CLL B-cell clones with clinical outcome and gene expression patterns in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive pentostatin IV over 10-30 minutes, cyclophosphamide IV over 30-60 minutes, and rituximab* IV on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 3-12 or until blood counts recover. Treatment repeats every 21 days for a total of 6 courses in the absence of unacceptable toxicity. NOTE: *Patients receive rituximab IV on days 1, 3, and 5 for course 1 only; for courses 2-6, patients receive rituximab on day 1 only Eight weeks after completion of PCR therapy, patients receive alemtuzumab SC on days 1, 3, and 5. In the absence of disease progression or unacceptable toxicity, treatment repeats weekly for 4 weeks for patients with complete remission or nodular partial remission (PR) after PCR OR for 18 weeks for patients with PR, stable disease, or progressive disease after PCR. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 26-110 patients will be accrued for this study within 1.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria: - Peripheral blood absolute lymphocyte count greater than 5,000/mm^3 - Lymphocytosis must comprise small to moderate size lymphocytes with no greater than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically - Phenotypically characterized CLL defined by the following: - Predominant population of cells share B-cell antigens with CD5 in the absence of other pan-T-cell markers (CD3 or CD2) - B cell expresses kappa and lambda light chains - Surface immunoglobulin with low cell surface density expression - Requires chemotherapy, as indicated by any of the following: - Disease-related symptoms - Weight loss of 10% or more within the past 6 months - Extreme fatigue - Fevers greater than 100.5°F for 2 weeks without evidence of infection - Night sweats without evidence of infection - Evidence of progressive marrow failure manifested by the development of or worsening anemia (hemoglobin no greater than 10 g/dL) and/or thrombocytopenia (platelet count no greater than 100,000/mm^3) - Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly - Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy - Progressive lymphocytosis with an increase of greater than 50% over a 2-month period OR an anticipated doubling time of less than 6 months - Demonstrated progression after at least 1 course of either an alkylating agent-based or purine nucleoside-based (e.g., fludarabine) regimen OR failed to achieve a meaningful response OR relapsed after prior therapy - No bone marrow dysplasia related to prior therapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Bilirubin no greater than 2 mg/dL (unless secondary to tumor, hemolysis, or Gilbert’s syndrome) Renal - Creatinine no greater than 2.0 mg/dL OR - Creatinine clearance at least 40 mL/min Cardiovascular - No New York Heart Association class III or IV heart failure Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 2 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - See Chemotherapy - No prior alemtuzumab - At least 8 weeks since prior rituximab Chemotherapy - See Disease Characteristics - At least 6 weeks since prior chemotherapy - No prior pentostatin, cyclophosphamide, and rituximab (PCR) therapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - No concurrent oral or IV antibiotics for active infection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SanfordKempin, Study Chair, St. Vincents Comprehensive Cancer Center
Additional Information:
Study ID Numbers: CDR0000343796; ECOG-2903
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074282
Other Refractory Chronic Lymphocytic Leukemia Studies:
1. Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients with Progressive B-Cell Lymphocytic Leukemia
2. Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia
3. Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
4. Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
5. Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer
Related Studies:
Other refractory chronic lymphocytic leukemia Clinical Trials
Other Clinical Trials
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Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
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