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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:
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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

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