Combination Chemotherapy, Total-Body Irradiation, and Alemtuzumab in Treating Patients Undergoing an Autologous Stem Cell Transplant for Stage I, Stage II, Stage III, or Stage IV Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00276809|
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : September 26, 2016
RATIONALE: Giving combination chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. A monoclonal antibody, such as alemtuzumab, is given to kill any remaining cancer cells. Chemotherapy and radiation therapy (total-body irradiation) are given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. Giving combination chemotherapy, total-body irradiation, and alemtuzumab together with autologous peripheral stem cell transplant may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with total-body irradiation and alemtuzumab works in treating patients undergoing an autologous stem cell transplant for stage I, stage II, stage III, or stage IV chronic lymphocytic leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Biological: alemtuzumab Biological: filgrastim Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: etoposide Drug: fludarabine phosphate Drug: melphalan Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy||Phase 2|
- Determine the safety and feasibility of cytoreductive fludarabine and cyclophosphamide followed by high-dose myeloablative therapy comprising total-body irradiation, cyclophosphamide, and alemtuzumab in patients undergoing autologous filgrastim (G-CSF)-mobilized peripheral blood stem cell transplantation for stage I-IV chronic lymphocytic leukemia.
- Determine the clinical and molecular remission rate and duration in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter, open label, nonrandomized study. Patients are assigned to 1 of 2 cohorts according to time of enrollment.
- Cytoreductive induction therapy: All patients receive fludarabine IV and cyclophosphamide IV on days 1-3. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) or partial response (PR) proceed to stem cell mobilization. Patients with stage III or IV disease at this point are removed from study.
- Stem cell mobilization: All patients receive Dexa-BEAM comprising oral dexamethasone once daily on days 1-10; carmustine IV and melphalan IV on day 2; and cytarabine IV twice daily and etoposide IV once daily on days 4-7. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 8 and continuing until leukapheresis is completed. Patients undergo peripheral blood stem cell (PBSC) harvest between days 20 and 28. Patients without an adequate number of collected PBSCs may receive a second course of Dexa-BEAM. Patients achieving CR or very good PR proceed to high-dose myeloablative therapy and PBSC transplantation (PBSCT) with or without consolidation therapy.
- Consolidation therapy: Beginning between 1-2 months after completion of Dexa-BEAM, patients in cohort 2 receive alemtuzumab IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and then proceed to high-dose myeloablative therapy and PBSCT within 1 month after completion of consolidation therapy. Patients in cohort 1 do not receive consolidation therapy and proceed directly to high-dose therapy within 3 months after completion of stem cell mobilization.
- High-dose myeloablative therapy and PBSCT: Patients undergo total-body irradiation on days -7 to -5. Patients then receive cyclophosphamide IV on days -4 and -3 and alemtuzumab IV over 2 hours on days -10, -9, -8, -6, and -4. Patients undergo PBSCT on day 0.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Masking:||None (Open Label)|
|Official Title:||Campath 1H (Alemtuzumab) Combined With High-Dose Therapy and Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia|
|Study Start Date :||June 2001|
|Actual Primary Completion Date :||September 2004|
|Actual Study Completion Date :||September 2004|
- Safety and feasibility of CAMPATH-1H included into the myeloablative regimen (cyclophosphamide and TBI) of the CLL3 protocol monitoring of treatment related mortality and morbidity (CTC scale) continuous
- Rate and duration of molecular responses MRD levels continuous
- Rate and duration of clinical remissions NCIE sponsored remission criteria for CLL continuous
- Overall survival time from treatment to death continuous
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276809
|Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin|
|Berlin, Germany, D-12200|
|Essen, Germany, D-45122|
|Asklepios Klinik St. Georg|
|Hamburg, Germany, D-20099|
|Medizinische Hochschule Hannover|
|Hannover, Germany, D-30625|
|Heidelberg, Germany, D-69120|
|Staedtisches Klinikum Karlsruhe gGmbH|
|Karlsruhe, Germany, 76133|
|University Hospital Schleswig-Holstein - Kiel Campus|
|Kiel, Germany, D-24105|
|Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg|
|Magdeburg, Germany, D-39120|
|Mainz, Germany, 55101|
|Klinikum der Universitaet Muenchen - Grosshadern Campus|
|Munich, Germany, D-81377|
|Klinikum Rechts Der Isar - Technische Universitaet Muenchen|
|Munich, Germany, D-81675|
|Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm|
|Ulm, Germany, D-89081|
|Study Chair:||Stephan Stilgenbauer, MD||Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm|