Not Signed In -
Hydroxyurea |
Droxia; Hydrea |
Clinical Trial: Imatinib Mesylate With or Without Interferon Alfa or Cytarabine Compared With Interferon Alfa Followed by Allogeneic Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
This study is currently recruiting patients.
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Purpose
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Stem cell transplantation may be able to replace immune cells that were destroyed by cancer therapy. It is not yet known which treatment regimen is most effective in treating chronic myelogenous leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of imatinib mesylate with or without interferon alfa or cytarabine compared with interferon alfa followed by allogeneic stem cell transplantation in treating patients who have newly diagnosed chronic phase chronic myelogenous leukemia.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| chronic phase chronic myelogenous leukemia childhood chronic myelogenous leukemia | Drug: cytarabine Drug: hydroxyurea Drug: imatinib mesylate Drug: interferon alfa Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Procedure: biological response modifier therapy Procedure: bone marrow ablation with stem cell support Procedure: bone marrow transplantation Procedure: chemotherapy Procedure: cytokine therapy Procedure: enzyme inhibitor therapy Procedure: interferon therapy Procedure: peripheral blood stem cell transplantation Procedure: protein tyrosine kinase inhibitor therapy | Phase III |
MedlinePlus related topics: Bone Marrow Diseases; Immune System and Disorders; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphatic Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Imatinib Mesylate Alone or With Interferon alfa or Low-Dose Cytarabine Versus Interferon alfa Standard Therapy Followed By Allogeneic Stem Cell Transplantation in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Further Study Details:
OBJECTIVES:
- Compare the hematologic, cytogenetic, and molecular response rates in patients with newly diagnosed chronic phase chronic myelogenous leukemia treated with imatinib mesylate alone or with interferon alfa or low-dose cytarabine vs interferon alfa standard therapy.
- Compare the group-dependent, progression-free and overall survival and time to progression in patients treated with these regimens.
- Compare the efficacy of allogeneic stem cell transplantation vs imatinib mesylate-based therapy in patients eligible for transplantation.
- Compare the efficacy of reduced-intensity conditioning vs standard conditioning in patients over 45 years of age.
- Determine the time to and duration of hematologic, cytogenetic, and molecular responses and correlate these factors in patients treated with these regimens.
- Compare the short- and long-term adverse effects of these regimens in these patients.
- Compare the presentation, duration, and responses to therapy of accelerated and blastic phases in patients treated with these regimens.
- Determine the survival of high-risk patients after early allografting.
- Determine the influence of pre-transplantation therapies on the outcome of allogeneic stem cell transplantation in these patients.
OUTLINE: This is a randomized, multicenter, pilot study. Patients are stratified according to participating center. Patients with low- to intermediate-risk disease are randomized to 1 of 4 treatment arms. Patients with high-risk disease are randomized to 1 of 3 treatment arms with imatinib mesylate-based regimens.
- Arm I: Patients receive oral imatinib mesylate once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral imatinib mesylate as in arm I. Patients also receive interferon alfa subcutaneously (SC) 3 times a week beginning at least 3 months after the start of imatinib mesylate.
- Arm III: Patients receive oral imatinib mesylate as in arm I. Patients also receive cytarabine SC up to twice daily for 5 days monthly beginning at least 3 months after the start of imatinib mesylate.
- Arm IV: After initial cytoreduction with hydroxyurea, patients receive interferon alfa SC daily with or without hydroxyurea. In the absence of a complete response after 3 months, patients may also receive low-dose cytarabine SC once daily. Treatment continues for up to 21 months. Patients who fail interferon alfa therapy are crossed over to receive imatinib mesylate.
Patients who fail therapy with imatinib mesylate and are eligible for an allogeneic transplantation are stratified according to availability of donor (HLA-identical related vs unrelated), status, and participating center. Patients are randomized to receive an allogeneic transplantation or continue any salvage therapy.
Patients who are not eligible for allogeneic transplantation receive hydroxyurea and cytarabine or high-dose chemotherapy with autologous stem cell rescue followed by interferon- or imatinib mesylate-based therapy.
Patients over 45 years of age are further randomized to receive an age-adjusted standard conditioning regimen or reduced intensity preparative regimen (mini transplantation) prior to allogeneic transplantation.
Patients are followed every 6 months for 3 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,600 patients (400 per treatment arm) will be accrued for this study within 4-5 years.
Eligibility
Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed chronic phase chronic myelogenous leukemia (CML)
- bcr-abl positive
- No blasts, promyelocytes, myelocytes, or metamyelocytes in the peripheral blood
- Availability of a HLA-identical sibling or unrelated donor
PATIENT CHARACTERISTICS: Age
- Any age
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No second malignancy requiring therapy
- No evidence of disease-related symptoms or extramedullary disease (including hepatosplenomegaly)
- No serious diseases that would preclude study participation
PRIOR CONCURRENT THERAPY: Biologic therapy
- No prior interferon
Chemotherapy
- No prior chemotherapy other than hydroxyurea
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy
Surgery
- Not specified
Other
- Prior anagrelide allowed
- No participation in another clinical trial
Location and Contact Information
Germany
Caritas - Krakenhaus Lebach, Lebach, 66822, Germany; Recruiting
Harald Jost, MD 49-6881-501-273
Deutsche Klinik fuer Diagnostik, Wiesbaden, D-65191, Germany; Recruiting
Andreas Koehler, MD 49-611-577-614
Diakone - Krankenhaus, Schwabisch Hall, 74523, Germany; Recruiting
Thomas Geer, MD 49-791-753-4411 tgeer@diaksha.de
Diakonissen-Krankenhaus Stuttgart, Stuttgart, D-70176, Germany; Recruiting
Else G. Heidemann, MD 49-711-991-3501
DR Herbert - Nieper Krankenhaus Goslar, Goslar, 38642, Germany; Recruiting
Andreas Hoyer, MD 49-5321-555-401
Eberhard Karls Universitaet, Tuebingen, D-72076, Germany; Recruiting
Tim Henrik Brummendorf, MD 49-7071-298-0648 tim.bruemmendorf@med.uni-tuebingen.de
Evangelische Krankenhaus Hamm, Hamm, DOH-59063, Germany; Recruiting
Leopold Balleisen, MD 49-2381-589-1333 LBalleisen@evkhamm.de
Evangelisches Krankenhaus Essen Werden, ESSEN, D-45239, Germany; Recruiting
Franz-Karl Baur, MD 49-201-4089-2099
Gemeinschaftspraxis fuer Haematologie und Internistische Onkologie, Berlin, D-12103, Germany; Recruiting
Friedrich Ludwig, MD 49-30-757-047-20 onkopraxis-lmu@GMX.de
Bonn, 53117, Germany; Recruiting
Karl Grips, MD 49-228-67-38-00
Haematologische Praxis, Stuttgart, D-70173, Germany; Recruiting
Gregor Springer, MD 49-711-222-0244
Haematologische Praxis, Weiden, 92637, Germany; Recruiting
J. Weiss, MD 49-961-320-60
Haematologisch-Onkologische Schwerpunktpraxis, Berlin, 13357, Germany; Recruiting
Ilona Blau, MD 49-30-461-4857
Hamatologisch - Onkologische Praxis Wurzburg, Wurzburg, 97070, Germany; Recruiting
Rudolf Schlag, MD 49-931-322-670
Hamatologisch - Onkologische Schwerpunktpraxis, Muenster, 48149, Germany; Recruiting
Juergen Wehmeyer, MD 49-251-620-080 dr.wehmeyer@uni-muenster.de
Hamatologische Schwerpunktpraxis, Munich, 81679, Germany; Recruiting
Helmut Hitz, MD 49-89-9972-0275
Hamatologische Sprechstunde, Brandenburg, 14770, Germany; Recruiting
Fischer-Lampsatis, MD 49-3381-411-555
Helios Klinikum Wuppertal, Wuppertal, D-42283, Germany; Recruiting
Aruna Raghavachar, MD, PhD 49-202-896-3351 araghavachar@wuppertal.helios-kliniken.de
Hematologische Onkologische Praxis, Regensburg, 93047, Germany; Recruiting
Robert Dengler, MD 49-941-566-342 robert.dougler@t-online.de
Hospital Maria-Hilf II, Monchengladbach, D-41063, Germany; Recruiting
Lange, MD 49-2161-892-2212
III Medizinische Klinik Mannheim, Mannheim, D-68305, Germany; Recruiting
Michael Schatz, MD 49-621-383-4114
Internistische Praxisgemeinschaft, Germering, 82110, Germany; Recruiting
Johann Mittermueller, MD 49-89-842-910
Internistische Schwerpunktpraxis, Russelsheim, 65428, Germany; Recruiting
M. Baldus, MD 49-6142-940-321
Klinik fuer Onkologie - Katharinenhospital Stuttgart, Stuttgart, D-70174, Germany; Recruiting
Hans-Guenther Mergenthaler, MD 49-711-278-5601 h.mergenthaler@katharinehospital.de
Klinikum Der Hansestadt Stralsund - Klin. West, STRALSUND, D-18410, Germany; Recruiting
Thomas Heinz Ittel, MD 49-3831-35-2700 medizinische.klinik@klinikum-stralsund.de
Klinikum der J.W. Goethe Universitaet, Frankfurt, D-60590, Germany; Recruiting
Dieter Hoelzer, MD 49-69-6301-5194
Klinikum der Stadt Ludwigshafen am Rhein, Ludwigshafen am Rhein, D-67063, Germany; Recruiting
Henrich, MD 49-621-503-3900 henrichd@klilu.de
Klinikum der Universitaet Regensburg, Regensburg, D-93042, Germany; Recruiting
Stefan W. Krause, MD 49-941-944-5538
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen, Munich, D-81377, Germany; Recruiting
Torsten Haferlach, MD 49-89-7095-4970
Klinikum Kempten Oberallgaeu, Kempten, 87439, Germany; Recruiting
Gatter, MD 49-831-530-2226
Klinikum Krefeld GmbH, Krefeld, D-47805, Germany; Recruiting
S. Helmer, MD 49-2151-32-2740
Klinikum Lippe - Lemgo, LEMGO, D-32657, Germany; Recruiting
Hans-Peter Lohrmann, MD 49-5261-26-4123
Klinikum Remscheid GMBH, Remscheid, 42859, Germany; Recruiting
Arthur Wehmeier, MD 49-21-9113-3900
Krankenhaus / Klinikum Krefeld, Aachen, 52074, Germany; Recruiting
Michaela Johnen, MD 49-241-736-08
Krankenhaus Muenchen Schwabing, Muenchen, 80804, Germany; Recruiting
Christof Fischer, MD 49-89-3068-2389
Kreiskrankenhaus Aurich, Aurich, 26603, Germany; Recruiting
Langer, MD 49-4941-94-5000 langer@kkh-aurich.de
Kreiskrankenhaus Siegen, Siegen, D-57076, Germany; Recruiting
Schulz, MD 49-271-705-0
Kreiskrankenhaus, Bad Hersfeld, 36251, Germany; Recruiting
P J Majunke, MD 49-6621-881779
Medical University Hospital Homburg, Homburg, 66421, Germany; Recruiting
Hans W. Pees, MD 49-6841-162-3000
Medizinische Universitaetsklinik und Poliklinik, Heidelberg, 69115, Germany; Recruiting
Anthony D. Ho, MD, PhD 49-6221-56-8001 anthony_ho@med.uni-heidelberg.de
Onkologische Schwerpunktpraxis Bielefeld, Bielefeld, D-33602, Germany; Recruiting
Marianne Just, MD 49-521-137-930
Onkologische Schwerpunktpraxis Leer, Leer, D-26789, Germany; Recruiting
Lothar Mueller, MD 49-491-987-910 Lothar.Mueller@onkologie-leer.de
Praxis Dres. F.+G. Doering, Bremen, 28205, Germany; Recruiting
Gabriele Doering, MD 49-421-498-5068
Praxis Fuer Haemotologie Und Internistischer Onkologie, Wuppertal, 42105, Germany; Recruiting
Werner Fett, MD 49-202-449-232 fett-onkologe@t-online.de
Praxis Für, Straubing, 94315, Germany; Recruiting
Matthias Demandt, MD 49-9421-907-77
Praxisgemeinschaft, Tuebingen, 72070, Germany; Recruiting
Swen H. Jacki, MD 49-7071-5678-88
Trier, D-54290, Germany; Recruiting
Bernhard Rendenbach, MD 49-651-493-93 info@straurenlau.de
Robert-Bosch-Krankenhaus, Stuttgart, 70376, Germany; Recruiting
Walter Aulitzky, MD 49-711-8101-3506 walter.aulitzky@rbk.de
Ruprecht - Karls - Universitaet Heidelberg, Heidelberg, 69115, Germany; Recruiting
Stefan Fruehauf, MD 49-622-156-2781
Saint Georg-Hospital, Hamburg, D-20099, Germany; Recruiting
Rutjes, MD 49-40-2890-2416
Schwerpunktpraxis fuer Haematologie und Internistische Onkologie, Berlin, D-10117, Germany; Recruiting
Christian Sperling, MD 49-30-2804-1960
St. Hedwig Kranken Haus, Berlin, 10115, Germany; Recruiting
Christian Boewer, MD 49-30-2311-2255
St. Marien - Krankenhaus Siegen GMBH, Siegen, D-57072, Germany; Recruiting
Winfried Gassmann 0271 231 2260
St. Marien Hospital at Katholisches Krankenhaus hagen gem. GmbH, Hagen, 58095, Germany; Recruiting
Hartmut Eimermacher, MD 49-2331-129-250 h.eimermacher@kkh-hagen.de
Stadtische Kliniken Delmenhorst, Delmenhorst, 27753, Germany; Recruiting
Funke, MD 49-4221-994-101
Staedt Klinikum Karlsruhe GGMBH, Karlsruhe, 76133, Germany; Recruiting
Joerg Th Fischer, MD 49-721-974-3001 haematologie@klinikum-karlsruhe.de
Universitaetsklinikum Essen, ESSEN, D-45122, Germany; Recruiting
Ulrich Duehrsen 49-201-723-2417
Universitaetsklinikum Goettingen, Gottingen, D-37075, Germany; Recruiting
Claudia Binder, MD, PhD 49-551-39-2331
Universitaets-Krankenhaus Eppendorf, Hamburg, D-20246, Germany; Recruiting
M. de Wit, MD 49-40-428-035-940
Universitatsklinik Homburg, Homburg, 66421, Germany; Recruiting
Michael G.M. Pfreundschuh, MD 49-6841-162-3084
Universitatsklinikum Heidelberg, Heidelberg, 69115, Germany; Recruiting
Elke Brants 49-6221-56-8006
University Hospital Schleswig-Holstein - Kiel Campus, Kiel, D-24116, Germany; Recruiting
Robert Schoch, MD 49-431-1697-5226
University Wurzburg, Wurzburg, D-97070, Germany; Recruiting
M. E. Goebeler, MD 49-931-201-7080
Vincentius Krankenhaus, Karlsruhe, D-76137, Germany; Recruiting
Gerhard Goeckel, MD 49-721-8108-3035 gerhard.goeckel@vincentius-ka.de
Westpfalz-Klinikum GmbH, Kaiserslautern, D-67653, Germany; Recruiting
Katja Buhl 49-631-203-1872
Switzerland
Basel, CH 4051, Switzerland; Recruiting
Walter Weber-Stadelmann, MD 41-61-261-0225 cancer@bluewin.ch
Study chairs or principal investigators
Ruediger Hehlmann, MD, Study Chair, III. Medizinische Klinik Mannheim
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000271424; III-MK-CML-IV; EU-20248; NCT00055874
Record last reviewed: February 2003
Last Updated: April 4, 2005
Record first received: March 6, 2003
ClinicalTrials.gov Identifier: NCT00055874
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: February 2003
Last Updated: April 4, 2005
Record first received: March 6, 2003
ClinicalTrials.gov Identifier: NCT00055874
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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