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| ID | Type | Description | Link |
|---|---|---|---|
| EU-20553 |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label, nonrandomized study.
After completion of study, patients are followed periodically.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose therapy + autologous PBSCT | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological |
| ||
| carmustine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Patients with chronic lymphocytic leukemia, meeting 1 of the following criteria:
Binet stage B or C disease
Binet stage A disease and at high risk for disease progression, defined as the following:
Polymerase chain reaction-amplifiable clonal CDRIII rearrangement of the IgV_H
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Dreger | Universitaets-Kinderklinik Heidelberg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik | Vienna | A-1090 | Austria | |||
| Hanuschkrankenhaus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22490331 | Result | Dreger P, Dohner H, McClanahan F, Busch R, Ritgen M, Greinix H, Fink AM, Knauf W, Stadler M, Pfreundschuh M, Duhrsen U, Brittinger G, Hensel M, Schetelig J, Winkler D, Buhler A, Kneba M, Schmitz N, Hallek M, Stilgenbauer S; German CLL Study Group. Early autologous stem cell transplantation for chronic lymphocytic leukemia: long-term follow-up of the German CLL Study Group CLL3 trial. Blood. 2012 May 24;119(21):4851-9. doi: 10.1182/blood-2011-09-378505. Epub 2012 Apr 5. |
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|
| cyclophosphamide | Drug |
|
| cytarabine | Drug |
|
| dexamethasone | Drug |
|
| etoposide | Drug |
|
| fludarabine phosphate | Drug |
|
| melphalan | Drug |
|
| bone marrow ablation with stem cell support | Procedure |
|
| peripheral blood stem cell transplantation | Procedure |
|
| radiation therapy | Radiation |
|
| 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 |
| Vienna |
| A-1140 |
| Austria |
| Humaine - Clinic | Bad Saarow | D-15526 | Germany |
| Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin | Berlin | D-12200 | Germany |
| Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch | Berlin | D-13122 | Germany |
| Universitaetsklinikum Bonn | Bonn | D-53105 | Germany |
| Praxis Dres. F.& G. Doering | Bremen | D-28205 | Germany |
| Universitatsklinikum Carl Gustav Carus | Dresden | D-01307 | Germany |
| Michael Schaefers und Partner | Duisburg | D-47051 | Germany |
| Universitaetsklinikum Duesseldorf | Düsseldorf | D-40225 | Germany |
| Onkologische Schwerpunkt Praxis | Erlangen | D-91052 | Germany |
| Universitaetsklinikum Essen | Essen | D-45122 | Germany |
| Malteser Krankenhaus | Flensburg | D-24939 | Germany |
| Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie | Giessen | D-35392 | Germany |
| Universitätsklinikum Göttingen | Göttingen | D-37075 | Germany |
| Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet | Greifswald | D-17487 | Germany |
| Asklepios Klinik St. Georg | Hamburg | D-20099 | Germany |
| St. Marien-Hospital Hamm - Klinik Knappenstrasse | Hamm | D-59071 | Germany |
| Krankenhaus Siloah - Medizinische Klinik II | Hanover | D-30449 | Germany |
| Medizinische Hochschule Hannover | Hanover | D-30625 | Germany |
| Universitaets-Kinderklinik Heidelberg | Heidelberg | D-69120 | Germany |
| Universitatsklinikum Heidelberg | Heidelberg | D-69120 | Germany |
| Universitaetsklinikum des Saarlandes | Homburg | D-66421 | Germany |
| Klinikum der Friedrich-Schiller Universitaet Jena | Jena | D-07740 | Germany |
| Westpfalz-Klinikum GmbH | Kaiserslautern | D-67653 | Germany |
| Gemeinschaftspraxis fuer Haematologie, Onkologie und Infektiologie | Karlsruhe | D-76135 | Germany |
| Internistische Gemeinschaftspraxis - Kassel | Kassel | D-34117 | Germany |
| Staedtisches Krankenhaus Kiel | Kiel | D-23116 | Germany |
| University Leipzig Clinic of Internal Medicine | Leipzig | D-04103 | Germany |
| Universitaets - Kinderklinik - Luebeck | Lübeck | D-23538 | Germany |
| Sana Kliniken Luebeck | Lübeck | D-23560 | Germany |
| Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg | Magdeburg | D-39120 | Germany |
| Universitatsklinik Mainz | Mainz | D-55101 | Germany |
| Krankenhaus Maria Hilf GmbH | Mönchengladbach | D-41063 | Germany |
| Klinikum der Universitaet Muenchen - Innenstadt Campus | Munich | D-80331 | Germany |
| Krankenhaus Muenchen Schwabing | Munich | D-80804 | Germany |
| Klinikum der Universitaet Muenchen - Grosshadern Campus | Munich | D-81377 | Germany |
| Staedtisches Krankenhaus Muenchen - Harlaching | Munich | D-81545 | Germany |
| University of Muenster | Münster | D-48129 | Germany |
| Internistische Praxis - Neuss | Neuss | D-41460 | Germany |
| Praxis fuer Haematologie und Interne Onkologie | Norderstedt | D-22844 | Germany |
| Klinikum Nuernberg - Klinikum Nord | Nuremberg | D-90419 | Germany |
| Internistische Gemeinschaftspraxis - Oldenburg | Oldenburg | D-26121 | Germany |
| Klinikum Oldenburg | Oldenburg | D-26133 | Germany |
| Klinikum Ernst Von Bergmann | Potsdam | D-14467 | Germany |
| Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock | Rostock | D-18057 | Germany |
| Diakonie Klinikum Stuttgart | Stuttgart | D-70176 | Germany |
| Buergerhospital Stuttgart | Stuttgart | D-70191 | Germany |
| Internistische Praxis - Trier | Trier | D-54290 | Germany |
| Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm | Ulm | D-89081 | Germany |
| Deutsche Klinik fuer Diagnostik | Wiesbaden | D-65191 | Germany |
| Hamatologisch - Onkologische Praxis Wurzburg | Würzburg | D-97070 | Germany |
| University Wurzburg | Würzburg | D-97070 | Germany |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D002330 | Carmustine |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D003907 | Dexamethasone |
| D005047 | Etoposide |
| C042382 | fludarabine phosphate |
| D008558 | Melphalan |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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