Cyclophosphamide and Total Body Irradiation in Treating Patients Who Are Undergoing an Autologous Peripheral Stem Cell Transplant For Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Biological: filgrastimProcedure: bone marrow ablation with stem cell supportProcedure: peripheral blood stem cell transplantationRadiation: radiation therapy
- Registration Number
- NCT00275015
- Lead Sponsor
- German CLL Study Group
- Brief Summary
RATIONALE: Giving chemotherapy before a peripheral 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. Chemotherapy or radiation therapy is then 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.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an peripheral stem cell transplant for chronic lymphocytic leukemia.
- Detailed Description
OBJECTIVES:
Primary
* Determine the safety and feasibility of autologous peripheral blood stem cell transplantation in patients with chronic lymphocytic leukemia treated with cyclophosphamide and total-body irradiation.
Secondary
* Determine the safety, feasibility, and efficacy of combination therapy comprising dexamethasone, carmustine, cytarabine, etoposide, and melphalan (Dexa-BEAM) and filgrastim (G-CSF) mobilization in patients treated with this regimen.
* Determine the efficacy of ex-vivo graft purging in patients treated with this regimen.
* Determine the incidence of complete clinical and molecular remissions in patients treated with this regimen.
* Determine the progression-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter, open-label, nonrandomized study.
* Cytoreductive treatment: Patients undergo 2-4 courses of cytoreductive treatment, preferably following the fludarabine and cyclophosphamide (FC) protocol.
* Stem cell mobilization: Patients achieving a complete remission (CR) or partial remission (PR) and stable blood counts undergo stem cell mobilization comprising dexamethasone, carmustine, cytarabine, etoposide, melphalan (Dexa-BEAM), and filgrastim (G-CSF). Patients with an adequate number of mobilized cells undergo stem cell collection. Patients with CR or very good PR proceed to myeloablative therapy.
* Myeloablative therapy: Patients undergo total-body irradiation on day -4 and receive cyclophosphamide IV on days -4 and -3.
* Autologous peripheral blood stem cell transplantation (PBSCT): Patients undergo autologous PBSCT on day 0.
After completion of study, patients are followed periodically.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 169
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High dose therapy + autologous PBSCT filgrastim 1. Cytoreductive treatment: (preferentially) FC (2-4 cycles) 2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles) 3. Myeloablation: fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0) High dose therapy + autologous PBSCT carmustine 1. Cytoreductive treatment: (preferentially) FC (2-4 cycles) 2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles) 3. Myeloablation: fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0) High dose therapy + autologous PBSCT cyclophosphamide 1. Cytoreductive treatment: (preferentially) FC (2-4 cycles) 2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles) 3. Myeloablation: fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0) High dose therapy + autologous PBSCT cytarabine 1. Cytoreductive treatment: (preferentially) FC (2-4 cycles) 2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles) 3. Myeloablation: fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0) High dose therapy + autologous PBSCT dexamethasone 1. Cytoreductive treatment: (preferentially) FC (2-4 cycles) 2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles) 3. Myeloablation: fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0) High dose therapy + autologous PBSCT etoposide 1. Cytoreductive treatment: (preferentially) FC (2-4 cycles) 2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles) 3. Myeloablation: fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0) High dose therapy + autologous PBSCT fludarabine phosphate 1. Cytoreductive treatment: (preferentially) FC (2-4 cycles) 2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles) 3. Myeloablation: fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0) High dose therapy + autologous PBSCT bone marrow ablation with stem cell support 1. Cytoreductive treatment: (preferentially) FC (2-4 cycles) 2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles) 3. Myeloablation: fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0) High dose therapy + autologous PBSCT melphalan 1. Cytoreductive treatment: (preferentially) FC (2-4 cycles) 2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles) 3. Myeloablation: fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0) High dose therapy + autologous PBSCT peripheral blood stem cell transplantation 1. Cytoreductive treatment: (preferentially) FC (2-4 cycles) 2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles) 3. Myeloablation: fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0) High dose therapy + autologous PBSCT radiation therapy 1. Cytoreductive treatment: (preferentially) FC (2-4 cycles) 2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles) 3. Myeloablation: fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)
- Primary Outcome Measures
Name Time Method Safety of autologous peripheral stem cell transplantation (PBSCT) as measured by a treatment-related mortality of < 5% at 12 months following transplant Feasibility of PBSCT as measured by > 50% of included patients proceeding to transplant
- Secondary Outcome Measures
Name Time Method Safety of mobilization comprising dexamethasone, carmustine, cytarabine, etoposide, and melphalan (Dexa-BEAM) as measured by a treatment-related mortality of < 5% before transplant phase Efficacy of Dexa-BEAM mobilization as measured by the amount of CD34+ cells > 4x10e6/kg at harvest Complete clinical remissions by NIH criteria at 3 months following transplant Molecular remissions by CDR3 PCR at 3 months following transplant Progression-free survival by NIH criteria at 5 years from study entry
Trial Locations
- Locations (53)
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
🇩🇪Berlin, Germany
Internistische Praxis - Trier
🇩🇪Trier, Germany
Universitaetsklinikum Bonn
🇩🇪Bonn, Germany
Malteser Krankenhaus
🇩🇪Flensburg, Germany
Diakonie Klinikum Stuttgart
🇩🇪Stuttgart, Germany
Universitaetsklinikum Duesseldorf
🇩🇪Duesseldorf, Germany
Humaine - Clinic
🇩🇪Bad Saarow, Germany
Praxis Dres. F.& G. Doering
🇩🇪Bremen, Germany
Universitatsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Michael Schaefers und Partner
🇩🇪Duisburg, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Onkologische Schwerpunkt Praxis
🇩🇪Erlangen, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
🇩🇪Greifswald, Germany
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
🇩🇪Giessen, Germany
Universitätsklinikum Göttingen
🇩🇪Göttingen, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Westpfalz-Klinikum GmbH
🇩🇪Kaiserslautern, Germany
Universitaets-Kinderklinik Heidelberg
🇩🇪Heidelberg, Germany
Krankenhaus Siloah - Medizinische Klinik II
🇩🇪Hannover, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
St. Marien-Hospital Hamm - Klinik Knappenstrasse
🇩🇪Hamm, Germany
University Leipzig Clinic of Internal Medicine
🇩🇪Leipzig, Germany
Universitatsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitaetsklinikum des Saarlandes
🇩🇪Homburg, Germany
Klinikum der Friedrich-Schiller Universitaet Jena
🇩🇪Jena, Germany
Internistische Gemeinschaftspraxis - Kassel
🇩🇪Kassel, Germany
Universitaets - Kinderklinik - Luebeck
🇩🇪Lubeck, Germany
Sana Kliniken Luebeck
🇩🇪Luebeck, Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
🇩🇪Magdeburg, Germany
Krankenhaus Muenchen Schwabing
🇩🇪Munich, Germany
Krankenhaus Maria Hilf GmbH
🇩🇪Moenchengladbach, Germany
University of Muenster
🇩🇪Muenster, Germany
Universitatsklinik Mainz
🇩🇪Mainz, Germany
Klinikum der Universitaet Muenchen - Innenstadt Campus
🇩🇪Munich, Germany
Klinikum Nuernberg - Klinikum Nord
🇩🇪Nuernberg, Germany
Staedtisches Krankenhaus Muenchen - Harlaching
🇩🇪Munich, Germany
Praxis fuer Haematologie und Interne Onkologie
🇩🇪Norderstedt, Germany
Internistische Praxis - Neuss
🇩🇪Neuss, Germany
Internistische Gemeinschaftspraxis - Oldenburg
🇩🇪Oldenburg, Germany
Klinikum Oldenburg
🇩🇪Oldenburg, Germany
Klinikum Ernst Von Bergmann
🇩🇪Potsdam, Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
🇩🇪Rostock, Germany
Buergerhospital Stuttgart
🇩🇪Stuttgart, Germany
Hamatologisch - Onkologische Praxis Wurzburg
🇩🇪Wurzburg, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
University Wurzburg
🇩🇪Wurzburg, Germany
Deutsche Klinik fuer Diagnostik
🇩🇪Wiesbaden, Germany
Gemeinschaftspraxis fuer Haematologie, Onkologie und Infektiologie
🇩🇪Karlsruhe, Germany
Staedtisches Krankenhaus Kiel
🇩🇪Kiel, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
🇩🇪Munich, Germany
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
🇦🇹Wien, Austria
Hanuschkrankenhaus
🇦🇹Vienna, Austria