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PETHEMA LAL-RI/96: Behandling til patienter med standardrisiko for akut lymfatisk leukæmi

15. maj 2009 opdateret af: PETHEMA Foundation

Formålet med den nuværende protokol er at prøve at forbedre resultaterne af kemoterapibehandling hos patienter med ALL, som ikke er indiceret til perifer stamcelletransplantation i første remission, med en intensiv konsolidering efterfulgt af re-induktioner.

Studieoversigt

Status

Afsluttet

Betingelser

Akut lymfatisk leukæmi

Intervention / Behandling

Detaljeret beskrivelse

Induktionsterapi:

Patienter med standardrisiko får vincristin (1,5 mg/m2)IV på dag 1, 8, 15 og 22; daunorubicin (30 mg/m2)IV på dag 1, 8, 15 og 22; oral eller IV prednison 60 mg/m2/dag, dag 1 til 27 og 30 mg/m2/dag, dag 28 til 35; asparaginase 10.000 UI/m2 IM eller IV, dag 10 til 12, 17 til 19 og 24 til 26; cyclophosphamid (500 mg/m2) IV dag 1, 2 og 29; methotrexat, cytosin arabinosid og hydrocortison, dag 1 til 22.

Patienter ældre end 55 år behandles ikke med asparaginase og cyclophosphamid.

Konsolideringsterapi (1):

Standardrisiko: Mercaptopurin 50 mg/m2, PO, dag 1 til 7, 28-35 og 56-63; methotrexat (3g/m2)IV/24 timer, dag 1, 28 og 56; VM-26 (150 mg/m2)/12 timer, IV, dag 14 og 42; ARA-C (500 mg/m2)/12 timer, IV dage 14-15 og 42-43; intratekal behandling, dag 1, 28 og 56.

Patienter over 50 år: Mercaptopurin (50 mg/m2), PO, dag 1 til 7, 28-35 og 56-63; methotrexat (1,5 g/m2) IV/24 timer, dag 1, 28 og 56; VM-26 (150 mg/m2)/12 timer, IV dag 14 og 42; ARA-C (500 mg/m2)/12 timer, IV dage 14-15 og 42-43; intratekal behandling, dag 1, 28 og 56.

Konsolideringsterapi (2)/Reinduktion: en cyklus svarende til induktion. Det starter en uge efter sidste dosis mercaptopurin. Dexamethason 10 mg/m2/dag, PO eller IV, dag 1-14 og 5 mg/m2/dag, PO eller IV dag 15-21; VCR: 1,5 mg/m2 IV, dag 1, 8 og 15; Daunorubicin 30 mg/m2 IV, dag 1, 2, 8 og 9; cyclophosphamid 600 mg/m2/dag IV, dag 1 og 15; Asparaginase: 10.000 UI/m2 IM eller IV, dag 1-3 og 15-17; intratekalt behandling dag 1 og 15

Vedligeholdelsesterapi 1: administration af kontinuerlig kemoterapi (mercaptopurin og methotrexat) og reduktioner indtil et år fra diagnosen.

Kontinuerlig kemoterapi:
- MP 50 mg/m2/dag PO
- MTX 20 mg/m2/uge IM
Reduktioner
- VCR: 1,5 mg/m2 IV, dag 1.
- PDN: 60 mg/m2/dag, IV eller PO dag 1 til 7
- L-ASA: 20.000 UI/m2, IM eller IV dag 1.
- Intratekalt dag 1

Syv cyklusser, uge 25, 29, 33, 37, 41, 45 og 49.

Vedligeholdelsesterapi 2: administration af kontinuerlig kemoterapi (mercaptopurin og methotrexat) mens andet år efter diagnosen (uge 53 til 104).

MP 50 mg/m2/dag, PO
MTX 20 mg/m2/uge, IM.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

374

Fase

Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Spanien
- - Albacete, Spanien
    - Complejo Hospitalario Universitario de Albacete
  - Alicante, Spanien
    - Hospital General de Alicante
  - Avila, Spanien
    - Hospital Ntra. Sra. Sonsoles
  - Badajoz, Spanien
    - Hospital Regional Universitario Infanta Cristina
  - Barcelona, Spanien
    - Hospital Del Mar
  - Barcelona, Spanien
    - Hospital de La Santa Creu i Sant Pau
  - Barcelona, Spanien
    - Hospital Vall d'hebrón
  - Barcelona, Spanien
    - Hospital Clinic
  - Barcelona, Spanien
    - Hospital Valle Hebrón-Materno Infantil
  - Basurto, Spanien
    - Basurtuko Ospitalea
  - Ciudad Real, Spanien
    - Hospital Nuestra Señora de Alarcos
  - Cuenca, Spanien
    - Hospital Virgen de La Luz
  - Cáceres, Spanien
    - Complejo Hospitalario de Cáceres
  - Cádiz, Spanien
    - Hospital Puerta del Mar
  - Córdoba, Spanien
    - Complejo Hospitalario Reina Sofía
  - Elda, Spanien
    - Hospital General de Elda
  - Gerona, Spanien
    - Institut Català d'Oncologia,
  - Granada, Spanien
    - Hospital Universitario Virgen de las Nieves
  - Huelva, Spanien
    - Hospital Juan Ramón Jiménez
  - Huesca, Spanien
    - Hospital de San Jorge
  - Jaen, Spanien
    - Hospital Médico Quirúrgico Ciudad de Jaén
  - Jerez de la Frontera, Spanien
    - Hospital de Jerez de la Frontera
  - La Coruña, Spanien
    - Hospital Juan Canalejo
  - Lanzarote, Spanien
    - Hospital General de Lanzarote
  - Leon, Spanien
    - Complejo Hospitalario León
  - Lleida, Spanien
    - Hospital Arnau de Vilanova
  - Lugo, Spanien
    - Complexo Hospitalario Xeral-Calde
  - Madrid, Spanien
    - Hospital Ramon y Cajal
  - Madrid, Spanien
    - Hospital Clínico San Carlos de Madrid
  - Madrid, Spanien
    - Hospital 12 de Octubre
  - Madrid, Spanien
    - Hospital Doce de Octubre
  - Madrid, Spanien
    - Hospital Universitario La Paz
  - Madrid, Spanien
    - Hospital Universitario de La Princesa
  - Madrid, Spanien
    - Hospital De Fuenlabrada
  - Madrid, Spanien
    - Hospital de La Princesa
  - Madrid, Spanien
    - Hospital Puerta de Hierro
  - Madrid, Spanien
    - Clínica Puerta de Hierro
  - Madrid, Spanien
    - HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON, MADRID
  - Madrid, Spanien
    - Hospital Universitario Princcipe de Asturias
  - Manresa, Spanien
    - Althaia, Xarxa Asistencial de Manresa
  - Murcia, Spanien
    - Hospital General Morales Meseguer
  - Murcia, Spanien
    - Hospital Santa Maria del Rosell
  - Murcia, Spanien
    - Hospital Virgen del Castillo de Yecla
  - Málaga, Spanien
    - . Hospital Clínico Universitario Virgen de la Victoria
  - Málaga, Spanien
    - H. Carlos Haya
  - Palencia, Spanien
    - Hospital del Río Carrión
  - Palma de Mallorca, Spanien
    - Hospital Son Llatzer
  - Palma de Mallorca, Spanien
    - Complejo Asistencial Son Dureta
  - Palma de Mallorca, Spanien
    - Hospital Son Dureta
  - Palma de Mallorca, Spanien
    - Hospital Verge del Toro
  - Pamplona, Spanien
    - Clinica Universitaria de Navarra
  - Pamplona, Spanien
    - Hospital Virgen del Camino
  - Pontevedra, Spanien
    - Complejo Hospitalario de Pontevedra_Hospital Montecelo
  - Sagunto, Spanien
    - Hospital de Sagunto
  - Salamanca, Spanien
    - Hospital Clínico de Salamanca
  - San Pedro de Alcántara, Spanien
    - Hospital San Pedro De Alcantara
  - Sant Pere de Ribes, Spanien
    - Clínica Sant Camil
  - Santander, Spanien
    - Hospital Universitario Marqués de Valdecilla
  - Santiago de Compostela, Spanien
    - Complejo Hospitalario Universitario de Santiago
  - Santiago de Compostela, Spanien
    - Hospital de Santiago de Compostela
  - Segovia, Spanien
    - Hospital General de Segovia
  - Sevilla, Spanien
    - Hospital Universitario Virgen del Rocío
  - Sevilla, Spanien
    - H.U. Virgen del Rocío
  - Tarragona, Spanien
    - Hospital Joan XXIII
  - Tenerife, Spanien
    - Hospital Universitario de Canarias
  - Toledo, Spanien
    - Hospital Virgen de la Salud
  - Toledo, Spanien
    - Hospital Nuestra Señora del Prado
  - Valencia, Spanien
    - Fundación Instituto Valenciano de Oncología
  - Valencia, Spanien
    - Hospital Clínico Universitario de Valencia
  - Valencia, Spanien
    - Hospital La Fe
  - Valencia, Spanien
    - Hospital General Universitario
  - Valencia, Spanien
    - Hospital Clinic
  - Valencia, Spanien
    - Hospital Dr. Peset
  - Valencia, Spanien
    - Hospital Francesc de Borja
  - Valencia, Spanien
    - Hospital General Básico de la Defensa
  - Valladolid, Spanien
    - Hospital Clínico de Valladolid
  - Vigo, Spanien
    - Complejo Hospitalario Universitario de Vigo
  - Vigo, Spanien
    - Hospital Meixoeiro
  - Vitoria, Spanien
    - Hospital Txagorritxu
  - Vizcaya, Spanien
    - Hospital de Galdakao
  - Zaragoza, Spanien
    - Hospital Clinico Lozano Blesa
- Asturias
  - Oviedo, Asturias, Spanien
    - Hospital Central de Asturias
- Barcelona
  - Badalona, Barcelona, Spanien
    - Hospital Germans Trías i Pujol
  - Sabadell, Barcelona, Spanien
    - Corporacio Sanitaria Parc Tauli
  - Terrassa, Barcelona, Spanien
    - Hospital Mútua de Terrassa
- Castellón
  - Castello, Castellón, Spanien
    - Hospital General de Castellon
- Tarragona
  - Tortosa, Tarragona, Spanien
    - Hospital Verge de la Cinta

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

11 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inklusionskriterier:

Voksne (over 15 år) med ALL-standard risikerer ingen forudgående antiblastisk kemoterapi

Ekskluderingskriterier:

Moden B-ALL (FABL3) eller med cytogenetiske ALLE "Burkitt-lignende" ændringer (t[8;14], t[2;8], t[8;22])
Blandede former for ALT
Akut leukæmi ingen forskel
Patienter med koronarsygdomme, hjerteklap eller hypertensiv kardiopati
Patienter med kroniske leversygdomme
Kroniske lungelidelser
Nyreinsufficiens
Neurologiske disfunktioner
ECOG 3 og 4
Ingen underskrevet samtykkeerklæring

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Ikke-randomiseret
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Effektivitet af behandling hos voksne med standardrisiko for akut lymfatisk leukæmi Tidsramme: 2 år	2 år

Sekundære resultatmål

Resultatmål	Tidsramme
Demonstrer, at CNS-tilbagefaldet ikke er hyppigt i denne gruppe af patienter og ikke er nødvendigt kraniel strålebehandling Tidsramme: 2 år	2 år
For at evaluere behandlingstolerancen Tidsramme: 1 år	1 år

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

PETHEMA Foundation

Efterforskere

Studieleder: Ribera Josep Mª, Dr, Germans Trias i Pujol Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

P 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
JM 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.
Sanz 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.
Kantarjian HM, Walters RS, Keating MJ, Smith TL, O'Brien S, Estey EH, Huh YO, Spinolo J, Dicke K, Barlogie B, et al. Results of the vincristine, doxorubicin, and dexamethasone regimen in adults with standard- and high-risk acute lymphocytic leukemia. J Clin Oncol. 1990 Jun;8(6):994-1004. doi: 10.1200/JCO.1990.8.6.994.
GIMEMA ALL 0183: a multicentric study on adult acute lymphoblastic leukaemia in Italy. GIMEMA Cooperative Group. Br J Haematol. 1989 Mar;71(3):377-86.
Clarkson 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.
Lluesma-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.
Tomonaga 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
Smedyr 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.
Ellison 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.
Cuttner 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.
Stryckmans 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.
Bassan 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.
Hoelzer 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.
Fiere 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.
Durrant 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.
Dekker 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.
Kantarjian 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.
Preti 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.
Larson 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.
Mandelli 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.
Chessells 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.
JJ 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.
JM 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
Schorin MA, Blattner S, Gelber RD, Tarbell NJ, Donnelly M, Dalton V, Cohen HJ, Sallan SE. Treatment of childhood acute lymphoblastic leukemia: results of Dana-Farber Cancer Institute/Children's Hospital Acute Lymphoblastic Leukemia Consortium Protocol 85-01. J Clin Oncol. 1994 Apr;12(4):740-7. doi: 10.1200/JCO.1994.12.4.740.
Rivera 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.
Reiter 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.
Hoelzer 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.
JM 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.
Chessells 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.
von 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.
Saarinen 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.
Ortega JJ, Olive T, Diaz de Heredia C, Coll MT, Bastida P, Massuet L. Allogeneic and autologous bone marrow transplantation in AML in first remission. The Spanish experience. Bone Marrow Transplant. 1996 Nov;18 Suppl 2:53-8.
Attal 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.
Barrett 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.
De 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.
Schiller 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.
Mehta 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.
Powles 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.
Dicke 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.

Hjælpsomme links

Spanish association of Haematology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 1996

Primær færdiggørelse (Faktiske)

1. maj 2007

Studieafslutning (Faktiske)

1. december 2007

Datoer for studieregistrering

Først indsendt

29. juni 2007

Først indsendt, der opfyldte QC-kriterier