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
PHASE2
35 participants
INTERVENTIONAL
2002-06-30
2007-10-31
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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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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chemotherapy
Glivec
Eligibility Criteria
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Inclusion Criteria
* Fertile age women must do a pregnancy test in the 7 days previous at the beginning of clinical trial medication
* Performance status 0-2 (Appendix B); Is allowed performance status \> 2 because of LLA
* Patients without organ alteration: hepatic function: global bilirubin, AST, ALT, gamma-GT and alkaline phosphatase less than 2 times LSN; renal function: Creatinine \< 1,5 mg/dl o Clearance creatinine \> 60 ml/min; anormal renal function caused by LLA ; normal heart function (Appendix B): FEV \> 50%; No Chronic respiratory illness. If the anormal values are secondary of the experimental illness the investigator can decide himself if the patient can be included at the clinical trial.
* Negative HIV serology
* Written, oral or with witness informed consent. In patients \< 18 years old must be signed written and legal representative informed consent.
* No experimental chemotherapy or other experimental treatment. Allowed to begin induction chemotherapy from the diagnosis to confirm Ph. No major surgical process in the previous 14 days of the treatment Start.
Exclusion Criteria
* Previous history of coronary valvular, hypertensive cardiopathy illness
* Chronic hepatic illness
* Chronic respiratory insufficiency
* Renal insufficiency not caused by LLA
* Severe neurological problems not caused by LLA
* Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA
* Pregnancy and women
* Blastic crisis LMC
65 Years
ALL
No
Sponsors
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PETHEMA Foundation
OTHER
Responsible Party
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pethema
Principal Investigators
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Ribera Josep Mª, Dr
Role: STUDY_CHAIR
Germans Trias i Pujol Hospital
Locations
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Hospital General de Alicante
Alicante, Alicante, Spain
Hospital "Duran I Reynals"
Barcelona, Barcelona, Spain
Hospital "Santa Creu i Sant Pau"
Barcelona, Barcelona, Spain
Hospital Clínico y Provincial de Barcelona
Barcelona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Germans Trias i Pujol
Barcelona, Barcelona, Spain
Hospital Universitario "Germans Trias i Pujol"
Barcelona, Barcelona, Spain
Hospital Valle Hebrón-Materno Infantil
Barcelona, Barcelona, Spain
Hospital Valle Hebrón
Barcelona, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Puerta del Mar
Cadiz, Cádiz, Spain
Hospital Juan Canalejo
A Coruña, La Coruña, Spain
Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital Clínico San Carlos de Madrid
Madrid, Madrid, Spain
Hospital Doce de Octubre
Madrid, Madrid, Spain
Hospital Gregorio Marañón
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Hospital General Universitario Morales Meseguer.
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 Central de Asturias
Oviedo, Oviedo, Spain
Hospital Son Dureta
Palma de Mallorca, Palma de Mallorca, Spain
Hospital Son Llàtzer
Palma de Mallorca, Palma de Mallorca, Spain
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain
Hospital Clínico de Valencia
Valencia, Valencia, Spain
Hospital La Fe
Valencia, Valencia, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, , Spain
Countries
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References
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Schrappe M, Reiter A, Zimmermann M, Harbott J, Ludwig WD, Henze G, Gadner H, Odenwald E, Riehm H. Long-term results of four consecutive trials in childhood ALL performed by the ALL-BFM study group from 1981 to 1995. Berlin-Frankfurt-Munster. Leukemia. 2000 Dec;14(12):2205-22. doi: 10.1038/sj.leu.2401973.
Thomas X, Thiebaut A, Olteanu N, Danaila C, Charrin C, Archimbaud E, Fiere D. Philadelphia chromosome positive adult acute lymphoblastic leukemia: characteristics, prognostic factors and treatment outcome. Hematol Cell Ther. 1998 Jun;40(3):119-28.
Snyder DS, Nademanee AP, O'Donnell MR, Parker PM, Stein AS, Margolin K, Somlo G, Molina A, Spielberger R, Kashyap A, Fung H, Slovak ML, Dagis A, Negrin RS, Amylon MD, Blume KG, Forman SJ. Long-term follow-up of 23 patients with Philadelphia chromosome-positive acute lymphoblastic leukemia treated with allogeneic bone marrow transplant in first complete remission. Leukemia. 1999 Dec;13(12):2053-8. doi: 10.1038/sj.leu.2401589.
Arico M, Valsecchi MG, Camitta B, Schrappe M, Chessells J, Baruchel A, Gaynon P, Silverman L, Janka-Schaub G, Kamps W, Pui CH, Masera G. Outcome of treatment in children with Philadelphia chromosome-positive acute lymphoblastic leukemia. N Engl J Med. 2000 Apr 6;342(14):998-1006. doi: 10.1056/NEJM200004063421402.
Druker BJ, Tamura S, Buchdunger E, Ohno S, Segal GM, Fanning S, Zimmermann J, Lydon NB. Effects of a selective inhibitor of the Abl tyrosine kinase on the growth of Bcr-Abl positive cells. Nat Med. 1996 May;2(5):561-6. doi: 10.1038/nm0596-561.
Druker BJ, Sawyers CL, Kantarjian H, Resta DJ, Reese SF, Ford JM, Capdeville R, Talpaz M. Activity of a specific inhibitor of the BCR-ABL tyrosine kinase in the blast crisis of chronic myeloid leukemia and acute lymphoblastic leukemia with the Philadelphia chromosome. N Engl J Med. 2001 Apr 5;344(14):1038-42. doi: 10.1056/NEJM200104053441402.
Saffroy R, Lemoine A, Brezillon P, Frenoy N, Delmas B, Goldschmidt E, Souleau B, Nedellec G, Debuire B. Real-time quantitation of bcr-abl transcripts in haematological malignancies. Eur J Haematol. 2000 Oct;65(4):258-66. doi: 10.1034/j.1600-0609.2000.065004258.x.
Mitterbauer G, Nemeth P, Wacha S, Cross NC, Schwarzinger I, Jaeger U, Geissler K, Greinix HT, Kalhs P, Lechner K, Mannhalter C. Quantification of minimal residual disease in patients with BCR-ABL-positive acute lymphoblastic leukaemia using quantitative competitive polymerase chain reaction. Br J Haematol. 1999 Sep;106(3):634-43. doi: 10.1046/j.1365-2141.1999.01605.x.
Tabernero MD, Bortoluci AM, Alaejos I, Lopez-Berges MC, Rasillo A, Garcia-Sanz R, Garcia M, Sayagues JM, Gonzalez M, Mateo G, San Miguel JF, Orfao A. Adult precursor B-ALL with BCR/ABL gene rearrangements displays a unique immunophenotype based on the pattern of CD10, CD34, CD13 and CD38 expresssion. Leukemia. 2001 Mar;15(3):406-14. doi: 10.1038/sj.leu.2402060.
le Coutre P, Tassi E, Varella-Garcia M, Barni R, Mologni L, Cabrita G, Marchesi E, Supino R, Gambacorti-Passerini C. Induction of resistance to the Abelson inhibitor STI571 in human leukemic cells through gene amplification. Blood. 2000 Mar 1;95(5):1758-66.
Mahon FX, Deininger MW, Schultheis B, Chabrol J, Reiffers J, Goldman JM, Melo JV. Selection and characterization of BCR-ABL positive cell lines with differential sensitivity to the tyrosine kinase inhibitor STI571: diverse mechanisms of resistance. Blood. 2000 Aug 1;96(3):1070-9.
Weisberg E, Griffin JD. Mechanism of resistance to the ABL tyrosine kinase inhibitor STI571 in BCR/ABL-transformed hematopoietic cell lines. Blood. 2000 Jun 1;95(11):3498-505.
Gambacorti-Passerini C, Barni R, le Coutre P, Zucchetti M, Cabrita G, Cleris L, Rossi F, Gianazza E, Brueggen J, Cozens R, Pioltelli P, Pogliani E, Corneo G, Formelli F, D'Incalci M. Role of alpha1 acid glycoprotein in the in vivo resistance of human BCR-ABL(+) leukemic cells to the abl inhibitor STI571. J Natl Cancer Inst. 2000 Oct 18;92(20):1641-50. doi: 10.1093/jnci/92.20.1641.
Related Links
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Spanish association of Haematology
Other Identifiers
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02-0207 (nº AEMPS)
Identifier Type: -
Identifier Source: secondary_id
CSTI571BES02
Identifier Type: -
Identifier Source: org_study_id