The objective of current protocol is try improve the results of chemotherapy treatment in patients with ALL wich is not indicated the peripheral stem cell transplant in first remission, with an intensive consolidation follow by re-inductions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia
timeFrame
2 years
Secondary outcomes (2)
measure
Demonstrate that in this group of patients, the CNS relapse is not frequently and is not necessary cranial radiotherapy
timeFrame
2 years
measure
To evaluate the treatment tolerance
timeFrame
1 year
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
15 Years
Show eligibility criteria text
Inclusion Criteria:
* Adults (over 15 years) with ALL standard risk no prior antiblastic chemotherapy
Exclusion Criteria:
* Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t\[8;14\], t\[2;8\], t\[8;22\])
* Mixed forms of ALL
* Acute Leukemia no differentiate
* Patients with coronary disorders, valvular or hypertensive cardiopathy
* Patients with chronic liver disorders
* Chronic pulmonary disorders
* Renal insufficiency
* Neurologic disfunctions
* ECOG 3 and 4
* No signed consent form
References
Publications (40)
BACKGROUNDP Bastida, JJ Ortega, ME González-Valentín, C Calvo, J Marín, JM Ribera, M Fontanillas. Tratamiento de la leucemia aguda linfoblástica en niños. Resultados del protocolo PETHEMA 89. Sangre 1996; 41 (supl 3): 94
BACKGROUNDJM Ribera, M Fontanillas, A Oriol, E Feliu, J Maldonado, J Hernández-Rivas, J Marín, J Zuazu, C Rivas, J Alcalá, S Brunet, FJ Rafecas, J Carnero, J Besalduch, S Gardella, J Alvarez, J garcía Conde, F Fernández-Calvo, J Martínez, MJ Moro, R casanova, J Maciá, F Ortega, R Salinas, J varela, JF san Miguel, JJ Ortega. Leucemia aguda linfoblástica (LAL) del adulto. Resultados del protocolo PETHEMA LAL-89. Sangre 1996; 41 (supl 3): 94.
BACKGROUNDSanz MA, Martin G, Rayon C, Esteve J, Gonzalez M, Diaz-Mediavilla J, Bolufer P, Barragan E, Terol MJ, Gonzalez JD, Colomer D, Chillon C, Rivas C, Gomez T, Ribera JM, Bornstein R, Roman J, Calasanz MJ, Arias J, Alvarez C, Ramos F, Deben G. A modified AIDA protocol with anthracycline-based consolidation results in high antileukemic efficacy and reduced toxicity in newly diagnosed PML/RARalpha-positive acute promyelocytic leukemia. PETHEMA group. Blood. 1999 Nov 1;94(9):3015-21. PMID 10556184
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BACKGROUNDGIMEMA ALL 0183: a multicentric study on adult acute lymphoblastic leukaemia in Italy. GIMEMA Cooperative Group. Br J Haematol. 1989 Mar;71(3):377-86. PMID 2649141
BACKGROUNDClarkson B, Gaynor J, Little C, Berman E, Kempin S, Andreeff M, Gulati S, Cunningham I, Gee T. Importance of long-term follow-up in evaluating treatment regimens for adults with acute lymphoblastic leukemia. Haematol Blood Transfus. 1990;33:397-408. doi: 10.1007/978-3-642-74643-7_75. PMID 2182430
BACKGROUNDLluesma-Gonalons M, Pavlovsky S, Santarelli MT, Eppinger-Helf M, Dorticos Bavea E, Corrado C, Carnot J. Improved results of an intensified therapy in adult acute lymphocytic leukemia. Ann Oncol. 1991 Jan;2(1):33-9. doi: 10.1093/oxfordjournals.annonc.a057821. PMID 2009234
BACKGROUNDTomonaga M, Omine M, Morishima Y, Hirano M, Dogi H, Imai K, et al. . Individualized induction therapy followed by intensive consolidation and maintenance including asparaginase in adult ALL: JALSG-ALL87 study. Haematologica 1991; 76 (suppl 4): 68
BACKGROUNDSmedyr B, Simonsson B, Björkholm M, Carneskog J, Gahrton G, Grimfors G, et al. Treatment of adult acute lymphoblastic and undifferentiated (ALL/AUL) leukemia according to a national protocol in Sweden. Haematologica 1991; 76 (suppl 4): 107.
BACKGROUNDEllison RR, Mick R, Cuttner J, Schiffer CA, Silver RT, Henderson ES, Woliver T, Royston I, Davey FR, Glicksman AS, et al. The effects of postinduction intensification treatment with cytarabine and daunorubicin in adult acute lymphocytic leukemia: a prospective randomized clinical trial by Cancer and Leukemia Group B. J Clin Oncol. 1991 Nov;9(11):2002-15. doi: 10.1200/JCO.1991.9.11.2002. PMID 1941059
BACKGROUNDCuttner J, Mick R, Budman DR, Mayer RJ, Lee EJ, Henderson ES, Weiss RB, Paciucci PA, Sobol R, Davey F, et al. Phase III trial of brief intensive treatment of adult acute lymphocytic leukemia comparing daunorubicin and mitoxantrone: a CALGB Study. Leukemia. 1991 May;5(5):425-31. PMID 2033963
BACKGROUNDStryckmans P, De Witte T, Marie JP, Fillet G, Peetermans M, Bury J, Muus P, Andrien JM, Hayat M, Jaksic B, et al. Therapy of adult ALL: overview of 2 successive EORTC studies: (ALL-2 & ALL-3). The EORTC Leukemia Cooperative Study Group. Leukemia. 1992;6 Suppl 2:199-203. No abstract available. PMID 1578934
BACKGROUNDBassan R, Battista R, Rohatiner AZ, Love S, Carter M, Buelli M, Viero P, D'Emilio A, MacCallum P, Amess J, et al. Treatment of adult acute lymphoblastic leukaemia (ALL) over a 16 year period. Leukemia. 1992;6 Suppl 2:186-90. PMID 1578929
BACKGROUNDHoelzer D, Thiel E, Ludwig WD, Loffler H, Buchner T, Freund M, Heil G, Hiddemann W, Maschmeyer G, Volkers B, et al. Follow-up of the first two successive German multicentre trials for adult ALL (01/81 and 02/84). German Adult ALL Study Group. Leukemia. 1993 Aug;7 Suppl 2:S130-4. No abstract available. PMID 8361217
BACKGROUNDFiere D, Lepage E, Sebban C, Boucheix C, Gisselbrecht C, Vernant JP, Varet B, Broustet A, Cahn JY, Rigal-Huguet F, et al. Adult acute lymphoblastic leukemia: a multicentric randomized trial testing bone marrow transplantation as postremission therapy. The French Group on Therapy for Adult Acute Lymphoblastic Leukemia. J Clin Oncol. 1993 Oct;11(10):1990-2001. doi: 10.1200/JCO.1993.11.10.1990. PMID 8410124
BACKGROUNDDurrant IJ, Richards SM. Results of Medical Research Council trial UKALL IX in acute lymphoblastic leukaemia in adults: report from the Medical Research Council Working Party on Adult Leukaemia. Br J Haematol. 1993 Sep;85(1):84-92. doi: 10.1111/j.1365-2141.1993.tb08649.x. PMID 8251413
BACKGROUNDDekker AW, van't Veer MB, Haak HL, van der Lelie J, Ossenkoppele G, Schouten HC, et al. Conventional induction remission followed by intensive consolidation without maintenance therapy in adult acute lymphoblastic leukemia. Results from a phase II in 130 patients. Blood 1994; 84 (suppl 1) 144a.
BACKGROUNDKantarjian HM, O'Brien S, Smith T, Estey EH, Beran M, Preti A, Pierce S, Keating MJ. Acute lymphocytic leukaemia in the elderly: characteristics and outcome with the vincristine-adriamycin-dexamethasone (VAD) regimen. Br J Haematol. 1994 Sep;88(1):94-100. doi: 10.1111/j.1365-2141.1994.tb04982.x. PMID 7803263
BACKGROUNDPreti HA, Huh YO, O'Brien SM, Andreeff M, Pierce ST, Keating M, Kantarjian HM. Myeloid markers in adult acute lymphocytic leukemia. Correlations with patient and disease characteristics and with prognosis. Cancer. 1995 Nov 1;76(9):1564-70. doi: 10.1002/1097-0142(19951101)76:93.0.co;2-1. PMID 8635059
BACKGROUNDLarson RA, Dodge RK, Burns CP, Lee EJ, Stone RM, Schulman P, Duggan D, Davey FR, Sobol RE, Frankel SR, et al. A five-drug remission induction regimen with intensive consolidation for adults with acute lymphoblastic leukemia: cancer and leukemia group B study 8811. Blood. 1995 Apr 15;85(8):2025-37. PMID 7718875
BACKGROUNDMandelli F, Annino L, Rotoli B. The GIMEMA ALL 0183 trial: analysis of 10-year follow-up. GIMEMA Cooperative Group, Italy. Br J Haematol. 1996 Mar;92(3):665-72. doi: 10.1046/j.1365-2141.1996.00394.x. PMID 8616033
BACKGROUNDChessells JM, Bailey C, Richards SM. Intensification of treatment and survival in all children with lymphoblastic leukaemia: results of UK Medical Research Council trial UKALL X. Medical Research Council Working Party on Childhood Leukaemia. Lancet. 1995 Jan 21;345(8943):143-8. doi: 10.1016/s0140-6736(95)90164-7. PMID 7823668
BACKGROUNDJJ Ortega. Tratamiento de las leucemias agudas linfoblásticas del niño. Problemas actuales. En: J Maldonado, ed. Libro de Ponencias. XXXVIII Reunión Nacional de la Asociación Española de Hematología y Hemoterapia. 1996; 175-182.
BACKGROUNDJM Ribera. Quimioterapia de la leucemia aguda linfoblástica del adulto. En: Libro de Ponencias. En: J Maldonado, ed. Libro de Ponencias. XXXVIII Reunión Nacional de la Asociación Española de Hematología y Hemoterapia. 1996; 183-190
BACKGROUNDRivera GK, Raimondi SC, Hancock ML, Behm FG, Pui CH, Abromowitch M, Mirro J Jr, Ochs JS, Look AT, Williams DL, et al. Improved outcome in childhood acute lymphoblastic leukaemia with reinforced early treatment and rotational combination chemotherapy. Lancet. 1991 Jan 12;337(8733):61-6. doi: 10.1016/0140-6736(91)90733-6. PMID 1670723
BACKGROUNDReiter A, Schrappe M, Ludwig WD, Hiddemann W, Sauter S, Henze G, Zimmermann M, Lampert F, Havers W, Niethammer D, et al. Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients. Results and conclusions of the multicenter trial ALL-BFM 86. Blood. 1994 Nov 1;84(9):3122-33. PMID 7949185
BACKGROUNDHoelzer D. Critical evaluation of chemotherapy and transplantation of hematopoietic precursor cells in adult ALL. En: J Maldonado, ed. Libro de Ponencias. XXXVIII Reunión Nacional de la Asociación Española de Hematología y Hemoterapia. 1996; 191-193.
BACKGROUNDJM Ribera, JJ Ortega, A Oriol, M Fontanillas, J Maldonado, R Parody, C Rivas, JM Hernández-Rivas, MJ Terol, P Bastida, ME González-Valentín, E Feliu, J García-Conde, J Díaz-Mediavilla, JF san Miguel. Treatment of high-risk acute lymphoblastic leukemia (HRALL). Preliminary results of the protocol PETHEMA ALL-93. Acute Leukemias VII. Experimental Approaches and Novel Therapies. Ann Hematol 1997; 74 (suppl1): A41.
BACKGROUNDChessells JM, Bailey C, Wheeler K, Richards SM. Bone marrow transplantation for high-risk childhood lymphoblastic leukaemia in first remission: experience in MRC UKALL X. Lancet. 1992 Sep 5;340(8819):565-8. doi: 10.1016/0140-6736(92)92103-m. PMID 1355153
BACKGROUNDvon Bueltzingsloewen A, Esperou-Bourdeau H, Souillet G, Demeocq F, Mechinaud-Lacroix F, Michel G, Sadoun A, Bernaudin F, Cornu G, Donadieu J, et al. Allogeneic bone marrow transplantation following a busulfan-based conditioning regimen in young children with acute lymphoblastic leukemia: a Cooperative Study of the Societe Francaise de Greffe de Moelle. Bone Marrow Transplant. 1995 Oct;16(4):521-7. PMID 8528167
BACKGROUNDSaarinen UM, Mellander L, Nysom K, Ringden O, Schroeder H, Glomstein A, Gustafsson G. Allogeneic bone marrow transplantation in first remission for children with very high-risk acute lymphoblastic leukemia: a retrospective case-control study in the Nordic countries. Nordic Society for Pediatric Hematology and Oncology (NOPHO). Bone Marrow Transplant. 1996 Mar;17(3):357-63. PMID 8704687
BACKGROUNDOrtega JJ, Olivé T, Diaz de Heredia C, et al. Allogeneic and autologous bone amrrow transplant in acute lymphoblastic leukaemia. Bone Marrow Transplant 1996; 17 (supl 1): 76
BACKGROUNDAttal M, Blaise D, Marit G, Payen C, Michallet M, Vernant JP, Sauvage C, Troussard X, Nedellec G, Pico J, et al. Consolidation treatment of adult acute lymphoblastic leukemia: a prospective, randomized trial comparing allogeneic versus autologous bone marrow transplantation and testing the impact of recombinant interleukin-2 after autologous bone marrow transplantation. BGMT Group. Blood. 1995 Aug 15;86(4):1619-28. PMID 7632972
BACKGROUNDBarrett AJ. Bone marrow transplantation for acute lymphoblastic leukaemia. Baillieres Clin Haematol. 1994 Jun;7(2):377-401. doi: 10.1016/s0950-3536(05)80209-4. PMID 7803908
BACKGROUNDDe Witte T, Awwad B, Boezeman J, Schattenberg A, Muus P, Raemaekers J, Preijers F, Strijckmans P, Haanen C. Role of allogenic bone marrow transplantation in adolescent or adult patients with acute lymphoblastic leukaemia or lymphoblastic lymphoma in first remission. Bone Marrow Transplant. 1994 Nov;14(5):767-74. PMID 7889010
BACKGROUNDSchiller G, Feig SA, Territo M, Wolin M, Lill M, Belin T, Hunt L, Nimer S, Champlin R, Gajewski J. Treatment of advanced acute leukaemia with allogeneic bone marrow transplantation from unrelated donors. Br J Haematol. 1994 Sep;88(1):72-8. doi: 10.1111/j.1365-2141.1994.tb04979.x. PMID 7803259
BACKGROUNDMehta J, Powles R, Horton C, Milan S, Treleaven J, Tait D, Catovsky D. Bone marrow transplantation for primary refractory acute leukaemia. Bone Marrow Transplant. 1994 Sep;14(3):415-8. PMID 7994265
BACKGROUNDPowles R, Mehta J, Singhal S, Horton C, Tait D, Milan S, Pollard C, Lumley H, Matthey F, Shirley J, et al. Autologous bone marrow or peripheral blood stem cell transplantation followed by maintenance chemotherapy for adult acute lymphoblastic leukemia in first remission: 50 cases from a single center. Bone Marrow Transplant. 1995 Aug;16(2):241-7. PMID 7581142
BACKGROUNDDicke KA, Hoelzer DF, Gorin NC, Lowenberg B, Gale RP. The role of bone marrow transplantation in adult acute lymphocytic leukemia. Ann Oncol. 1993;4 Suppl 1:81-90. doi: 10.1093/annonc/4.suppl_1.s81. No abstract available. PMID 8338797