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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 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about 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 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as 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. 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 Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their 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 condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > 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 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
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
For Condition: chronic phase chronic myelogenous leukemia,childhood chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): III. Medizinische Klinik Mannheim ,
Synopsis: 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: Randomizedphase 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.
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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RuedigerHehlmann, Study Chair, III. Medizinische Klinik Mannheim
Universitaetsklinikum Essen *Recruiting*
ESSEN, , D-45122
Germany
Recruiting Ulrich Duehrsen 49-201-723-2417
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen *Recruiting*
Munich, , D-81377
Germany
Recruiting Torsten Haferlach 49-89-7095-4970
Westpfalz-Klinikum GmbH *Recruiting*
Kaiserslautern, , D-67653
Germany
Recruiting Katja Buhl 49-631-203-1872
Diakone - Krankenhaus *Recruiting*
Schwabisch Hall, , 74523
Germany
Recruiting Thomas Geer 49-791-753-4411
Evangelische Krankenhaus Hamm *Recruiting*
Hamm, , DOH-59063
Germany
Recruiting Leopold Balleisen 49-2381-589-1333
St. Marien Hospital at Katholisches Krankenhaus hagen gem. GmbH *Recruiting*
Hagen, , 58095
Germany
Recruiting Hartmut Eimermacher 49-2331-129-250
Internistische Schwerpunktpraxis *Recruiting*
Russelsheim, , 65428
Germany
Recruiting M. Baldus 49-6142-940-321
Medical University Hospital Homburg *Recruiting*
Homburg, , 66421
Germany
Recruiting Hans Pees 49-6841-162-3000
Stadtische Kliniken Delmenhorst *Recruiting*
Delmenhorst, , 27753
Germany
Recruiting Funke 49-4221-994-101
St. Hedwig Kranken Haus *Recruiting*
Berlin, , 10115
Germany
Recruiting Christian Boewer 49-30-2311-2255
Vincentius Krankenhaus *Recruiting*
Karlsruhe, , D-76137
Germany
Recruiting Gerhard Goeckel 49-721-8108-3035
University Wurzburg *Recruiting*
Wurzburg, , D-97070
Germany
Recruiting M. Goebeler 49-931-201-7080
Klinikum Remscheid GMBH *Recruiting*
Remscheid, , 42859
Germany
Recruiting Arthur Wehmeier 49-21-91-133900
Klinikum der J.W. Goethe Universitaet *Recruiting*
Frankfurt, , D-60590
Germany
Recruiting Dieter Hoelzer 49-69-6301-5194
Universitatsklinikum Heidelberg *Recruiting*
Heidelberg, , 69115
Germany
Recruiting Elke Brants 49-6221-56-8006
Gemeinschaftspraxis *Recruiting*
Bielefeld, , 33602
Germany
Recruiting Marianne Just 49-521-137-930
Katharinenhospital *Recruiting*
Stuttgart, , D-70174
Germany
Recruiting Hans-Guenther Mergenthaler 49-711-278-5601
Hamatologisch - Onkologische Schwerpunktpraxis *Recruiting*
Muenster, , 48149
Germany
Recruiting Juergen Wehmeyer 49-251-620-080
Praxisgemeinschaft *Recruiting*
Tuebingen, , 72070
Germany
Recruiting Swen Jacki 49-7071-5678-88
Diakonissen-Krankenhaus Stuttgart *Recruiting*
Stuttgart, , D-70176
Germany
Recruiting Else Heidemann 49-711-991-3501
Evangelisches Krankenhaus Essen Werden *Recruiting*
ESSEN, , D-45239
Germany
Recruiting Franz-Karl Baur 0201 4089 2099
Klinikum Kempten Oberallgaeu *Recruiting*
Kempten, , 87439
Germany
Recruiting Gatter 49-831-530-2226
Hospital Maria-Hilf II *Recruiting*
Monchengladbach, , D-41063
Germany
Recruiting Lange 49-2161-892-2212
Krankenhaus Muenchen Schwabing *Recruiting*
Muenchen, , 80804
Germany
Recruiting Christof Fischer 49-89-3068-2389
Hamatologische Sprechstunde *Recruiting*
Brandenburg, , 14770
Germany
Recruiting Fischer-Lampsatis 49-3381-411-555
Klinikum Lippe - Lemgo *Recruiting*
Lemgo, , D-32657
Germany
Recruiting Hans-Peter Lohrmann 49-5261-26-4123
Haematologische Praxis *Recruiting*
Weiden, , 92637
Germany
Recruiting J. Weiss 49-961-320-60
Witten University - Klinikum Wuppertal *Recruiting*
Wuppertal, , D-42283
Germany
Recruiting Aruna Raghavachar 49-202-896-3351
Staedt Klinikum Karlsruhe GGMBH *Recruiting*
Karlsruhe, , 76133
Germany
Recruiting Joerg Fischer 49-721-974-3001
Praxis Dres. F.+G. Doering *Recruiting*
Bremen, , 28205
Germany
Recruiting Gabriele Doering 49-421-498-5068
Saint Georg-Hospital *Recruiting*
Hamburg, , D-20099
Germany
Recruiting Rutjes 49-40-2890-2416
Krankenhaus / Klinikum Krefeld *Recruiting*
Aachen, , 52074
Germany
Recruiting Michaela Johnen 49-241-736-08
Kreiskrankenhaus *Recruiting*
Bad Hersfeld, , 36251
Germany
Recruiting P Majunke 49-6621-881779
Medizinische Universitaetsklinik und Poliklinik *Recruiting*
Heidelberg, , 69115
Germany
Recruiting Anthony Ho 49-6221-56-8001
Gemeinschaftspraxis fur *Recruiting*
Berlin, , 12103
Germany
Recruiting Friedrich Ludwig 49-30-757-047-20
Kreiskrankenhaus Siegen *Recruiting*
Siegen, , D-57076
Germany
Recruiting Schulz 49-271-705-0
Universitatsklinik Homburg *Recruiting*
Homburg, , 66421
Germany
Recruiting Michael Pfreundschuh 49-6841-162-3084
Universitaets-Krankenhaus Eppendorf *Recruiting*
Hamburg, , D-20246
Germany
Recruiting M. Wit 49-40-428-035-940
Internistische Praxisgemeinschaft *Recruiting*
Germering, , 82110
Germany
Recruiting Johann Mittermueller 49-89-842-910
Praxis Fuer Haemotologie Und Internistischer Onkologie *Recruiting*
Wuppertal, , 42105
Germany
Recruiting Werner Fett 49-202-449-232
St. Marien - Krankenhaus Siegen GMBH *Recruiting*
Siegen, , D-57072
Germany
Recruiting Winfried Gassmann 0271 231 2260
Deutsche Klinik fuer Diagnostik *Recruiting*
Wiesbaden, , D-65191
Germany
Recruiting Andreas Koehler 49-611-577-614
Klinikum Krefeld GmbH *Recruiting*
Krefeld, , D-47805
Germany
Recruiting S. Helmer 49-2151-32-2740
III Medizinische Klinik Mannheim *Recruiting*
Mannheim, , D-68305
Germany
Recruiting Michael Schatz 49-621-383-4114
University Hospital Schleswig-Holstein - Kiel Campus *Recruiting*
Kiel, , D-24116
Germany
Recruiting Robert Schoch 49-431-1697-5226
Ruprecht - Karls - Universitaet Heidelberg *Recruiting*
Heidelberg, , 69115
Germany
Recruiting Stefan Fruehauf 49-622-156-2781
Onkologische Schwerpunktpraxis Leer *Recruiting*
Leer, , D-26789
Germany
Recruiting Lothar Mueller 49-491-987-910
Hamatologisch - Onkologische Schwerpunktpraxis *Recruiting*
Berlin, , 10117
Germany
Recruiting Christian Sperling 49-30-2804-1960
Praxis Für *Recruiting*
Straubing, , 94315
Germany
Recruiting Matthias Demandt 49-9421-907-77
Robert-Bosch-Krankenhaus *Recruiting*
Stuttgart, , 70376
Germany
Recruiting Walter Aulitzky 49-711-8101-3506
Klinikum der Stadt Ludwigshafen am Rhein *Recruiting*
Ludwigshafen am Rhein, , D-67063
Germany
Recruiting Henrich 49-621-503-3900
Hamatologische Schwerpunktpraxis *Recruiting*
Munich, , 81679
Germany
Recruiting Helmut Hitz 49-89-9972-0275
Haematologische Praxis *Recruiting*
Stuttgart, , D-70173
Germany
Recruiting Gregor Springer 49-711-222-0244
Regional Hospital Aurich *Recruiting*
Aurich, , 26603
Germany
Recruiting Langer 49-4941-94-5000
Universitaetsklinik Goettingen *Recruiting*
Gottingen, , D-37075
Germany
Recruiting Claudia Binder 49-551-39-2331
Klinikum der Universitaet Regensburg *Recruiting*
Regensburg, , D-93042
Germany
Recruiting Stefan Krause 49-941-944-5538
Klinikum Der Hansestadt Stralsund - Klin. West *Recruiting*
Stralsund, , D-18410
Germany
Recruiting Thomas Ittel 49-3831-35-2700
Caritas - Krakenhaus Lebach *Recruiting*
Lebach, , 66822
Germany
Recruiting Harald Jost 49-6881-501-273
Haematologisch-Onkologische Scwerpunktpraxis *Recruiting*
Berlin, , 13357
Germany
Recruiting Ilona Blau 49-30-461-4857
DR Herbert - Nieper Krankenhaus Goslar *Recruiting*
Goslar, , 38642
Germany
Recruiting Andreas Hoyer 49-5321-555-401
Hamatologisch - Onkologische Praxis Wurzburg *Recruiting*
Wurzburg, , 97070
Germany
Recruiting Rudolf Schlag 49-931-322-670
Eberhard Karls Universitaet *Recruiting*
Tuebingen, , D-72076
Germany
Recruiting Tim Brummendorf 49-7071-298-0648
Hematologische Onkologische Praxis *Recruiting*
Regensburg, , 93047
Germany
Recruiting Robert Dengler 49-941-566-342
Additional Information:
Study ID Numbers: CDR0000271424; III-MK-CML-IV,EU-20248
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055874
Other Chronic Phase Chronic Myelogenous Leukemia Studies:
1. Chemotherapy, Biological Therapy, and/or Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
2. Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
3. Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate
4. STI571 in Treating Patients With Recurrent Leukemia
5. 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
Related Studies:
Other chronic phase chronic myelogenous leukemia Clinical Trials
Other Clinical Trials
Other Bremen Clinical Trials
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
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