Chemotherapy and Biological Therapy With or Without Bone Marrow or Peripheral Stem Cell Transplant in Treating Patients With Chronic Myelogenous Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00025402
- Lead Sponsor
- III. Medizinische Klinik Mannheim
- Brief Summary
RATIONALE: Giving chemotherapy, such as hydroxyurea, cytarabine, idarubicin, and etoposide before a donor bone marrow transplant or stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether chemotherapy is more effective with or without interferon alfa and/or bone marrow or stem cell transplant in treating patients with chronic myelogenous leukemia.
PURPOSE: This randomized phase III trial is studying chemotherapy and biological therapy to see how well it works compared with chemotherapy, biological therapy, and donor bone marrow transplant or autologous stem cell transplant in treating patients with chronic phase chronic myelogenous leukemia.
- Detailed Description
OBJECTIVES:
* Compare survival in patients with chronic myelogenous leukemia in early chronic phase treated with allogeneic bone marrow transplantation vs drug treatment with or without autologous peripheral blood stem cell transplantation.
* Compare survival of patients with late-phase disease treated with high-dose cytarabine vs low-dose cytarabine followed by autografting and interferon alfa maintenance.
* Compare survival of patients not responding cytogenetically to treatment with continued interferon alfa vs hydroxyurea.
* Determine frequency, time-point, and duration of hematological and cytogenetic remissions and of Philadelphia chromosome-negative and/or BCR-ABL-positive cells on the various treatments.
* Correlate the quality of hematological and cytogenetic remissions with survival time in patients treated with these regimens.
* Compare the course of the terminal phase in patients treated with these regimens.
* Compare the toxic effects of these regimens in these patients.
* Determine the effect of prognostic criteria and normal or subnormal WBC on chronic phase duration and survival time in patients treated with these regimens.
* Compare the effect of early vs late high-dose therapy plus autografting on feasibility, toxicity, and survival times in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to eligibility for transplantation (yes vs no).
All patients undergo cytoreduction comprising hydroxyurea (HU) IV daily.
Patients who are ineligible for or refuse transplantation are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive interferon alfa (IFN) subcutaneously (SC) daily. After 2 weeks of IFN therapy, patients also receive low-dose cytarabine (ARA-C) SC once daily for 10-15 days each month. Patients who do not achieve cytogenetic remission within 12 months continue to receive HU.
* Arm II: Patients receive IFN SC daily. After 2 weeks of IFN therapy, patients also receive low-dose ARA-C SC daily for 10-15 days each month. Patients who do not achieve cytogenetic remission within 12 months continue to receive IFN therapy SC daily.
Patients who are eligible for transplantation with a related donor undergo allogeneic bone marrow transplantation. Patients may receive HU or IFN prior to transplantation. Patients may also receive oral high-dose busulfan daily for 4 days with or without cyclophosphamide or cyclophosphamide with total body irradiation.
Patients who are eligible for transplantation but do not have a related donor undergo peripheral blood stem cell (PBSC) harvest and are randomized to 1 of 2 treatment arms.
* Arm III: Patients receive IFN and low-dose ARA-C as in arm I. Patients who accelerate on treatment may undergo autologous PBSC transplantation.
* Arm IV: Patients receive idarubicin IV, ARA-C IV over 2 hours, and etoposide IV on days 1-3. Patients then undergo leukapheresis. Beginning on day 8, patients receive filgrastim (G-CSF) SC daily until end of leukapheresis. Patients then receive oral high-dose busulfan daily for 4 consecutive days. The following day, patients undergo reinfusion of autologous PBSC. After blood count recovery, patients receive maintenance IFN 3 times weekly for 8 weeks and then daily.
Patients are followed every 3 months for 3 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study within 5 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Toxicity Survival Correlation of quality of hematological and cytogenetic remission with survival time Course of the terminal phase Frequency, time-point, and duration of hematologic and cytogenetic remissions and of Philadelphia chromosome-negative and/or BCL-ABL-positive cells Effect of prognostic criteria and normal or subnormal WBC on chronic phase duration and survival time Effect of early vs late high-dose therapy and autografting on feasibility, toxicity and survival times
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (178)
Tumorzentrum Berlin-Moabit
🇩🇪Berlin, Germany
Wenckebach - Krankenhaus
🇩🇪Berlin, Germany
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
🇩🇪Ansbach, Germany
Haematologisch Onkologische Praxis
🇩🇪Aachen, Germany
II. Medizinische Klinik
🇩🇪Aschaffenburg, Germany
Haematologische Praxis
🇩🇪Stuttgart, Germany
Krankenhaus Neukoelln
🇩🇪Berlin, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
Kinderklinik der Freier Universitaet Berlin
🇩🇪Berlin, Germany
Kinderklinik - Universitaetsklinikum Aachen
🇩🇪Aachen, Germany
Urologische Klinik - Universitaetsklinikum Aachen
🇩🇪Aachen, Germany
Klinikum Bremen-Mitte
🇩🇪Bremen, Germany
Marienhospital Bottrop gGmbH
🇩🇪Bottrop, Germany
Internistiche Praxis
🇩🇪Erfurt, Germany
Onkolog Gemeinschaftspraxis
🇩🇪Frankfurt, Germany
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
🇩🇪Hagen, Germany
Klinik fuer Radioonkologie und Strahlentherapie
🇩🇪Goeppingen, Germany
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Germany
Klinikum Herford
🇩🇪Herford, Germany
Kreiskrankenhaus Mellrichstadt
🇩🇪Mellrichstad, Germany
Klinikum Kempten Oberallgaeu
🇩🇪Kempten, Germany
Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
St. Marien-Hospital Hamm - Klinik Knappenstrasse
🇩🇪Hamm, Germany
Medizinische Universitaetsklinik und Poliklinik
🇩🇪Heidelberg, Germany
Caritas - Krakenhaus Lebach
🇩🇪Lebach, Germany
Medizinische Kl. Klinikum Innenstadt Universitaet Muenchen
🇩🇪Munich, Germany
Gemeinschaftspraxis Brunoehler
🇩🇪Karlsruhe, Germany
Haematologische / Onkologische Schwerpunktpraxis
🇩🇪Krefeld, Germany
Philipps-Universitaet Marburg Klinikum
🇩🇪Marburg, Germany
Klinikum Krefeld GmbH
🇩🇪Krefeld, Germany
Krankenhaus Maria Hilf GmbH
🇩🇪Moenchengladbach, Germany
Universitaets - Kinderpoliklinik
🇩🇪Muenchen, Germany
Praxis Fuer Haematologie/Onkologie
🇩🇪Luebeck, Germany
Schwerpunktpraxis fuer Haematologie und Onkologie
🇩🇪Saarbruecken, Germany
Kreiskrankenhaus Radebeul
🇩🇪Radebeul, Germany
Krankenhaus Muenchen Neuperlach
🇩🇪Munich, Germany
St. Elisabeth Krankenhaus
🇩🇪Ravensburg, Germany
Prosper-Hospital Recklinghausen
🇩🇪Recklinghausen, Germany
Klinikum Remscheid GmbH
🇩🇪Remscheid, Germany
Robert-Bosch-Krankenhaus
🇩🇪Stuttgart, Germany
Kliniken St. Antonius
🇩🇪Wuppertal 2, Germany
Schwerpunktpraxis für Rheumatologie und Haematologie/Internistische Onkologie
🇩🇪Tuebingen, Germany
Kreiskrankenhaus Siegen
🇩🇪Siegen, Germany
FMH f. Innere Medizin and Hematologie
🇨🇭Grosshochstetten, Switzerland
Klinik Hirslanden
🇨🇭Zurich, Switzerland
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Praxis Fuer Internistische Haematologie / Onkologie
🇩🇪Troisdorf, Germany
Bezirksspital Dornach
🇨🇭Dornach, Switzerland
Kantonsspital - St. Gallen
🇨🇭St. Gallen, Switzerland
Klinik fuer Onkologie - Katharinenhospital Stuttgart
🇩🇪Stuttgart, Germany
Helios Kliniken Wuppertal University Hospital
🇩🇪Wuppertal, Germany
Kantonsspital, Luzerne
🇨🇭Luzerne, Switzerland
Masaryk University Hospital
🇨🇿Brno, Czech Republic
Universitaetsspital-Basel
🇨🇭Basel, Switzerland
St. Irmgardis Krankenhaus
🇩🇪Viersen-Suechteln, Germany
Kreiskrankenhaus
🇩🇪Waldroel, Germany
Krankenhaus Hohe Warte Mediziniche Klinik
🇩🇪Bayreuth, Germany
Klinikum St. Marien
🇩🇪Amberg, Germany
St. Hedwig Kranken Haus
🇩🇪Berlin, Germany
Onkologische Schwerpunktpraxis Bielefeld
🇩🇪Bielefeld, Germany
Helios Klinikum Berlin
🇩🇪Berlin, Germany
Franziskus Hospital
🇩🇪Bietigheim, Germany
Krankenhaus Bietigheim
🇩🇪Bietigheim, Germany
Europahochhaus
🇩🇪Bochum, Germany
Universitaetsklinikum Bonn
🇩🇪Bonn, Germany
Staedtisches Klinikum Braunschweig
🇩🇪Braunschweig, Germany
Kreiskrankenhaus Boeblingen
🇩🇪Boeblingen, Germany
Medizinische Poliklinik
🇩🇪Bonn, Germany
Klinikum Coburg
🇩🇪Coburg, Germany
Medizinische Klinik Am Lukas - Krankenhaus
🇩🇪Buende, Germany
Praxis Gemeinschaft
🇩🇪Cologne, Germany
Praxis Fuer Haematologie Internistische Onkologie
🇩🇪Cologne, Germany
Medizinische Universitaetsklinik I at the University of Cologne
🇩🇪Cologne, Germany
Onkologische Schwerpunktpraxis
🇩🇪Cottbus, Germany
Stadt. KH Dresden - Neustadt
🇩🇪Dresden, Germany
Krankenhaus Dueren
🇩🇪Dueren, Germany
Universitaetsklinikum Duesseldorf
🇩🇪Duesseldorf, Germany
Medizinische Klinik I
🇩🇪Dresden, Germany
Michael Schaefers und Partner
🇩🇪Duisburg, Germany
Hans - Susemihl - Krankenhaus
🇩🇪Emden, Germany
Klinikum Erfurt
🇩🇪Erfurt, Germany
Praxis DR. J. Weniger
🇩🇪Erfurt, Germany
Onkologische Schwerpunkt Praxis
🇩🇪Erlangen, Germany
Medizinische Klinik III - Universitaetsklinikum Erlangen
🇩🇪Erlangen, Germany
St. Antonius Hospital
🇩🇪Eschweiler, Germany
Klinikum der J.W. Goethe Universitaet
🇩🇪Frankfurt, Germany
II Medizinische Klinik - Klinikum Fuerth
🇩🇪Fuerth, Germany
Kreiskrankenhaus Fuessen
🇩🇪Fuessen, Germany
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
🇩🇪Giessen, Germany
Evangelisches Krankenhaus Essen Werden
🇩🇪Essen, Germany
Klinikum Garmisch - Partenkirchen GmbH
🇩🇪Garmisch-Partenkirchen, Germany
DR Herbert - Nieper Krankenhaus Goslar
🇩🇪Goslar, Germany
Allgemeines Krankenhaus Altona
🇩🇪Hamburg, Germany
Klinik und Poliklinik fuer Urologie und Kinderurologie
🇩🇪Giessen, Germany
Universitaetsklinikum Goettingen
🇩🇪Goettingen, Germany
Allgemeines Krankenhaus Hagen
🇩🇪Hagen, Germany
Hermann - Holthusen Institute for Radiotherapy
🇩🇪Hamburg, Germany
Evangelische Krankenhaus Hamm
🇩🇪Hamm, Germany
Krankenhaus Siloah - Medizinische Klinik II
🇩🇪Hannover, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Haematologisch-Onkologische Praxis Altona
🇩🇪Hamburg, Germany
Universitaetsklinikum des Saarlandes
🇩🇪Homburg, Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
🇩🇪Idar-Oberstein, Germany
Diakonissen - Krankenhaus
🇩🇪Karlsruhe-Rueppur, Germany
Klinikum Kassel
🇩🇪Kassel, Germany
Praxis am Evangelischen Krankenhaus Bethanien
🇩🇪Iserlohn, Germany
Staedtisches Klinikum Karlsruhe gGmbH
🇩🇪Karlsruhe, Germany
St. Vincentius-Kliniken
🇩🇪Karlsruhe, Germany
University Hospital Schleswig-Holstein - Kiel Campus
🇩🇪Kiel, Germany
Vinzentiuskrankenhaus
🇩🇪Landau, Germany
Klinikum Lippe - Lemgo
🇩🇪Lemgo, Germany
Onkologische Schwerpunktpraxis - Leer
🇩🇪Leer, Germany
St Marienkrankenhaus
🇩🇪Ludwigshafen, Rhein, Germany
Onkologische Schwerpunktpraxis Lueneburg
🇩🇪Lueneburg, Germany
Luisenkrankenhaus
🇩🇪Lindenfels, Germany
Gemeinschaftspraxis
🇩🇪Nuernberg, Germany
Klinikum Minden
🇩🇪Minden, Germany
Krankenhaus Muenchen Schwabing
🇩🇪Munich, Germany
Praxis fuer Innere Medizin und Haematologie
🇩🇪Munich, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
🇩🇪Munich, Germany
Klinikum Nuernberg - Klinikum Nord
🇩🇪Nuernberg, Germany
Ruppiner Klinikum GMBH
🇩🇪Neuruppin, Germany
Klinikum Nuernberg - Klinikum Sued
🇩🇪Nuernberg, Germany
Paracelsus - Klinik Osnabrueck
🇩🇪Osnabrueck, Germany
Hematologische Praxis
🇩🇪Oldenburg, Germany
Klinikum Oldenburg
🇩🇪Oldenburg, Germany
Saechsische Schweiz Klinik
🇩🇪Sebnitz, Germany
Staedt Krankenhaus
🇩🇪Sebnitz, Germany
Staedtisches Krankenhaus
🇩🇪Pforzheim, Germany
Diakonie Klinikum Stuttgart
🇩🇪Stuttgart, Germany
Hematologische Onkologische Praxis
🇩🇪Regensburg, Germany
Jakobi Krankenhaus
🇩🇪Rheine, Germany
Klinikum Der Hansestadt Stralsund - Klin. West
🇩🇪Stralsund, Germany
Klinikum Der Stadt Villingen - Schwenningen
🇩🇪Villingen-Schwenningen, Germany
Southwest German Cancer Center at Eberhard-Karls-University
🇩🇪Tuebingen, Germany
Bundeswehr Krakenhaus
🇩🇪Ulm, Germany
Krankenhaus St. Michael
🇩🇪Voeklingen, Germany
St. Willehad Hospital
🇩🇪Wilhelmshaven, Germany
Deutsche Klinik fuer Diagnostik
🇩🇪Wiesbaden, Germany
Praxis Fuer Haemotologie Und Internistischer Onkologie
🇩🇪Wuppertal, Germany
Haematologisch-Onkologische Schwerpunktpraxis
🇩🇪Berlin, Germany
Asklepios Klinik Barmbek
🇩🇪Hamburg, Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Onkologischer Schwerpunkt Lerchenfeld
🇩🇪Hamburg, Germany
St. Johannes Hospital - Medical Klinik II
🇩🇪Duisburg, Germany
Haematologie Und Internistische Onkologie
🇩🇪Hanau, Germany
III Medizinische Klinik Mannheim
🇩🇪Mannheim, Germany
Staedtisches Krankenhaus Muenchen - Harlaching
🇩🇪Munich, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
🇩🇪Munich, Germany
Praxis fuer Haematologie und Interne Onkologie
🇩🇪Norderstedt, Germany
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Caritasklinik St. Theresia
🇩🇪Saarbrucken, Germany
Krankenhaus Barmherzige Brueder Regensburg
🇩🇪Regensburg, Germany
Klinikum der Universitaet Regensburg
🇩🇪Regensburg, Germany
St. Marien - Krankenhaus Siegen GMBH
🇩🇪Siegen, Germany
Krankenanstalt Mutterhaus der Borromaerinnen
🇩🇪Trier, Germany
Facharzt Fuer Onkologie-Hematologie
🇨🇭Bern, Switzerland
Inneremedizin FMH
🇨🇭Breitenbach, Switzerland
St. Joseph Hospital
🇩🇪Bremerhaven, Germany
Charite - Campus Virchow Klinikum
🇩🇪Berlin, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Charite - Campus Charite Mitte
🇩🇪Berlin, Germany
Malteser Krankenhaus
🇩🇪Flensburg, Germany
Klinik Konstanz
🇩🇪Konstanz, Germany
Onkolog - Haematolog Schwerpunktpraxis
🇩🇪Berlin, Germany
Zentralkrankenhaus
🇩🇪Bremerhaven, Germany
Klinikum der Friedrich-Schiller Universitaet Jena
🇩🇪Jena, Germany
Klinikum der Stadt Ludwigshafen am Rhein
🇩🇪Ludwigshafen am Rhein, Germany
Silesian Medical Academy
🇵🇱Katowice, Poland
Kantonspital Aarau
🇨🇭Aarau, Switzerland
Facharzt FMH Fuer Innere Medizin and Oncology
🇨🇭Baar, Switzerland
Oncology Institute of Southern Switzerland
🇨🇭Bellinzona, Switzerland
Inselspital Bern
🇨🇭Bern, Switzerland
Medical University of Gdansk
🇵🇱Gdansk, Poland
Hopital Cantonal Universitaire de Geneve
🇨🇭Geneva, Switzerland
Institut Central des Hopitaux Valaisans
🇨🇭Sion, Switzerland
UniversitaetsSpital Zuerich
🇨🇭Zurich, Switzerland