Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia
NCT ID: NCT00390897
Last Updated: 2008-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
360 participants
INTERVENTIONAL
2003-07-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Glivec
Interferon
Eligibility Criteria
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Inclusion Criteria
2. Age between 18 and 72 years (both included).
3. Performance status \< 2 on the ECOG scale (see Annex 3).
4. Secure written or oral informed consent in the presence of a witness and consent for biological samples (annexes 5 and 6).
Exclusion Criteria
2. When there is a compatible family donor in patients aged under 40 years or a non-relative donor in patients aged under 30 years (in whom allogenic transplant is still regarded as first-line treatment), the possibility of performing an allogenic transplant as first therapeutic option should be considered. In any case, as this aspect is still a matter of debate, it is left up to each group to take the relevant decision depending on the institution's policy.
3. Administration of other treatments before inclusion in the protocol (a maximum of 3 months of monotherapy with hydroxyurea is permitted).
4. Altered hepatic or renal function (SGOT, SGPT, total bilirubin and creatinine \> 1.5 times the upper limit of normality).
5. Uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure (functional class III/IV of the New York Heart Association classification), neuropsychiatric infection or disease (see annex 15).
6. Positive serology for HIV.
7. Record of cancer in the last 5 years (barring basal cell skin carcinoma and cervical carcinoma in situ).
8. Pregnancy or breastfeeding
18 Years
72 Years
ALL
No
Sponsors
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PETHEMA Foundation
OTHER
Responsible Party
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pethema
Principal Investigators
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Cervantes Francisco, Dr
Role: STUDY_CHAIR
Hospital Clinic of Barcelona
Locations
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Hospital Ntra. Sra. Sonsoles
Ávila, Avila, Spain
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, Spain
Hospital Clínic
Barcelona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Sant pau
Barcelona, Barcelona, Spain
Hospital Universitario "Germans Trias i Pujol"
Barcelona, Barcelona, Spain
Hospital vall d'Hebrón
Barcelona, Barcelona, Spain
Institut Català d'oncología
Barcelona, Barcelona, Spain
Hospital de Mataró
Mataró, Barcelona, Spain
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Hospital Mútua de Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Complejo Hospitalario Reina Sofía
Córdoba, Córdoba, Spain
Hospital Ruiz de Alda
Granada, Granada, Spain
Hospital Juan Ramón Jiménez
Huelva, Huelva, Spain
Hospital Médico Quirúrgico Ciudad de Jaén
Jaén, Jaen, Spain
Hospital Juan Canalejo
A Coruña, La Coruña, Spain
Hospital Arnau de Vilanova
Lleida, Lleida, Spain
Hospital de Alcorcón
Alcorcón, Madrid, Spain
Clínica La Concepción
Madrid, Madrid, Spain
Clínica Puerta de Hierro
Madrid, Madrid, Spain
Hospital Clínico San Carlos de Madrid
Madrid, Madrid, Spain
Hospital de Fuenlabrada
Madrid, Madrid, Spain
Hospital Doce de Octubre
Madrid, Madrid, Spain
Hospital Gregorio Marañón
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario Princcipe de Asturias
Madrid, Madrid, Spain
Hospital Son Llatzer
Palma de Mallorca, Mallorca, Spain
Hospital Universitario Morales Meseguer, Murcia
Murcia, Murcia, Spain
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, Málaga, Spain
Hospital Carlos Haya
Málaga, Málaga, Spain
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital de Navarra
Pamplona, Navarre, Spain
Hospital del Río Carrión
Palencia, Palencia, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Salamanca, Spain
Hospital General
Segovia, Segovia, Spain
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain
Hospital Joan XXIII
Tarragona, Tarragona, Spain
Hospital Verge de la Cinta
Tortosa, Tarragona, Spain
Hospital Clínico Universitario
Valencia, Valencia, Spain
Hospital dr. Peset
Valencia, Valencia, Spain
Hospital General Universitario
Valencia, Valencia, Spain
Hospital Universitario la Fe
Valencia, Valencia, Spain
Hospital Meixoeiro
Vigo, Vigo, Spain
Hospital Xeral
Vigo, Vigo, Spain
Hospital Virgen de la Concha
Zamora, Zamora, Spain
Hospital San Pedro de Alcántara
Cáceres, , Spain
Hospital general de Jerez de la Frontera
Jerez de la Frontera, , Spain
Hospital comarcal de Valdeorras
O'Barco de Valdeorras, , Spain
Countries
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References
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RUDKIN CT, HUNGERFORD DA, NOWELL PC. DNA CONTENTS OF CHROMOSOME PH1 AND CHROMOSOME 21 IN HUMAN CHRONIC GRANULOCYTIC LEUKEMIA. Science. 1964 Jun 5;144(3623):1229-31. doi: 10.1126/science.144.3623.1229.
Rowley JD. Letter: A new consistent chromosomal abnormality in chronic myelogenous leukaemia identified by quinacrine fluorescence and Giemsa staining. Nature. 1973 Jun 1;243(5405):290-3. doi: 10.1038/243290a0. No abstract available.
Heisterkamp N, Jenster G, ten Hoeve J, Zovich D, Pattengale PK, Groffen J. Acute leukaemia in bcr/abl transgenic mice. Nature. 1990 Mar 15;344(6263):251-3. doi: 10.1038/344251a0.
Daley GQ, Van Etten RA, Baltimore D. Induction of chronic myelogenous leukemia in mice by the P210bcr/abl gene of the Philadelphia chromosome. Science. 1990 Feb 16;247(4944):824-30. doi: 10.1126/science.2406902.
Goldman JM, Szydlo R, Horowitz MM, Gale RP, Ash RC, Atkinson K, Dicke KA, Gluckman E, Herzig RH, Marmont A, et al. Choice of pretransplant treatment and timing of transplants for chronic myelogenous leukemia in chronic phase. Blood. 1993 Oct 1;82(7):2235-8.
Italian Cooperative Study Group on Chronic Myeloid Leukemia; Tura S, Baccarani M, Zuffa E, Russo D, Fanin R, Zaccaria A, Fiacchini M. Interferon alfa-2a as compared with conventional chemotherapy for the treatment of chronic myeloid leukemia. N Engl J Med. 1994 Mar 24;330(12):820-5. doi: 10.1056/NEJM199403243301204.
Druker BJ, Talpaz M, Resta DJ, Peng B, Buchdunger E, Ford JM, Lydon NB, Kantarjian H, Capdeville R, Ohno-Jones S, Sawyers CL. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med. 2001 Apr 5;344(14):1031-7. doi: 10.1056/NEJM200104053441401.
Savage DG, Antman KH. Imatinib mesylate--a new oral targeted therapy. N Engl J Med. 2002 Feb 28;346(9):683-93. doi: 10.1056/NEJMra013339. No abstract available.
Kantarjian H, Sawyers C, Hochhaus A, Guilhot F, Schiffer C, Gambacorti-Passerini C, Niederwieser D, Resta D, Capdeville R, Zoellner U, Talpaz M, Druker B, Goldman J, O'Brien SG, Russell N, Fischer T, Ottmann O, Cony-Makhoul P, Facon T, Stone R, Miller C, Tallman M, Brown R, Schuster M, Loughran T, Gratwohl A, Mandelli F, Saglio G, Lazzarino M, Russo D, Baccarani M, Morra E; International STI571 CML Study Group. Hematologic and cytogenetic responses to imatinib mesylate in chronic myelogenous leukemia. N Engl J Med. 2002 Feb 28;346(9):645-52. doi: 10.1056/NEJMoa011573.
O'Brien SG, Guilhot F, Larson RA, Gathmann I, Baccarani M, Cervantes F, Cornelissen JJ, Fischer T, Hochhaus A, Hughes T, Lechner K, Nielsen JL, Rousselot P, Reiffers J, Saglio G, Shepherd J, Simonsson B, Gratwohl A, Goldman JM, Kantarjian H, Taylor K, Verhoef G, Bolton AE, Capdeville R, Druker BJ; IRIS Investigators. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2003 Mar 13;348(11):994-1004. doi: 10.1056/NEJMoa022457.
Kantarjian HM, Talpaz M, O'Brien S, Giles F, Garcia-Manero G, Faderl S, Thomas D, Shan J, Rios MB, Cortes J. Dose escalation of imatinib mesylate can overcome resistance to standard-dose therapy in patients with chronic myelogenous leukemia. Blood. 2003 Jan 15;101(2):473-5. doi: 10.1182/blood-2002-05-1451. Epub 2002 Sep 12.
Rea D, Legros L, Raffoux E, Thomas X, Turlure P, Maury S, Dupriez B, Pigneux A, Choufi B, Reman O, Stephane D, Royer B, Vigier M, Ojeda-Uribe M, Recher C, Dombret H, Huguet F, Rousselot P; Intergroupe Francais des Leucemies Myeloides Chronique; Group for Research in Adult Acute Lymphoblastic Leukemia. High-dose imatinib mesylate combined with vincristine and dexamethasone (DIV regimen) as induction therapy in patients with resistant Philadelphia-positive acute lymphoblastic leukemia and lymphoid blast crisis of chronic myeloid leukemia. Leukemia. 2006 Mar;20(3):400-3. doi: 10.1038/sj.leu.2404115.
Deng M, Daley GQ. Expression of interferon consensus sequence binding protein induces potent immunity against BCR/ABL-induced leukemia. Blood. 2001 Jun 1;97(11):3491-7. doi: 10.1182/blood.v97.11.3491.
Bhatia R, Wayner EA, McGlave PB, Verfaillie CM. Interferon-alpha restores normal adhesion of chronic myelogenous leukemia hematopoietic progenitors to bone marrow stroma by correcting impaired beta 1 integrin receptor function. J Clin Invest. 1994 Jul;94(1):384-91. doi: 10.1172/JCI117333.
Thiesing JT, Ohno-Jones S, Kolibaba KS, Druker BJ. Efficacy of STI571, an abl tyrosine kinase inhibitor, in conjunction with other antileukemic agents against bcr-abl-positive cells. Blood. 2000 Nov 1;96(9):3195-9.
Kano Y, Akutsu M, Tsunoda S, Mano H, Sato Y, Honma Y, Furukawa Y. In vitro cytotoxic effects of a tyrosine kinase inhibitor STI571 in combination with commonly used antileukemic agents. Blood. 2001 Apr 1;97(7):1999-2007. doi: 10.1182/blood.v97.7.1999.
Kontsioti F, Pappa V, Papasteriadis C, Economopulos T, Dervenoulas J, Papageorgiou E, Kalantzis D, Valsami S, Pappa M, Raptis S. In vitro effect of STI-571 in combination with A-interferon of the proliferation, differentiation and apoptosis of K562 cells. Hematol J 2002; suppl 1:980.
O´Brien SG, Vallance SE, Craddock C, Holyoake TL, Goldman JM. PEGIntron and STI571 combination evaluation study (PISCES) in chronic phase chronic myeloid leukaemia. Blood 2001; suppl.:3512.
Trabacchi E, Bassi S, Saglio G, Rege-cambrin G, Bonifazi F, De Vivo A, Testoni N, Martinelli G, Ruggeri D, Amabile M, Giannini B, Alberti D, Fincato GL, Tura S, Rosti G, Baccarani M. Pegylated recombinant interferon alfa 2b (PEGIntron) associated with imatinib mesylate (Glivec) in Ph chronic myeloid leukaemia (CML) in early chronic phase: a phase II study of the ICSG on CML. Hematol J 2002, suppl. :586
O´Dwyer ME, Mauro MJ, Aust S, Kuyl J, PaquetteR, Sawyers C, Druker BJ. Ongoing evaluation of the combination of imatinib mesylate (Glivectm) with low dose interferon-alpha for the treatment of chronic phase CML. Hematol J 2002; suppl. : 990
Cervantes F, Lopez-Garrido P, Montero MI, Jonte F, Martinez J, Hernandez-Boluda JC, Calbacho M, Sureda A, Perez-Rus G, Nieto JB, Perez-Lopez C, Roman-Gomez J, Gonzalez M, Pereira A, Colomer D. Early intervention during imatinib therapy in patients with newly diagnosed chronic-phase chronic myeloid leukemia: a study of the Spanish PETHEMA group. Haematologica. 2010 Aug;95(8):1317-24. doi: 10.3324/haematol.2009.021154. Epub 2010 Mar 10.
Related Links
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Spanish association of Haematology
Other Identifiers
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03-0289
Identifier Type: -
Identifier Source: secondary_id
LMC/PETHEMA
Identifier Type: -
Identifier Source: org_study_id