PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

May 15, 2009 updated by: PETHEMA Foundation

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.

Study Overview

Status

Completed

Conditions

Acute Lymphoblastic Leukemia

Intervention / Treatment

Detailed Description

Induction therapy:

Patients with standard risk receive vincristine (1,5 mg/m2)IV on days 1, 8, 15 and 22;daunorubicin (30 mg/m2)IV on days 1, 8, 15 and 22; oral or IV prednisone 60 mg/m2/day, days 1 to 27 and 30 mg/m2/day, days 28 to 35;asparaginase 10.000 UI/m2 IM or IV, days 10 to 12, 17 to 19 and 24 to 26;cyclophosphamide (500 mg/m2)IV days 1, 2 and 29; methotrexate, cytosine arabinoside and hydrocortisone, days 1 to 22.

Patients older than 55 years are not treated with asparaginase and cyclophosphamide.

Consolidation therapy (1):

Standard risk: Mercaptopurine 50 mg/m2, PO, days 1 to 7, 28-35 and 56-63; methotrexate (3g/m2)IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV, days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.

Patients over 50 years: Mercaptopurine (50 mg/m2), PO, days 1 to 7, 28-35 and 56-63;methotrexate (1,5 g/m2) IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.

Consolidation therapy (2)/Reinduction: one cycle similar to induction. It starts one week after last dose of mercaptopurine.Dexamethasone 10 mg/m2/day,PO or IV, days 1-14 and 5 mg/m2/day, PO or IV days 15-21; VCR: 1,5 mg/m2 IV, days 1, 8 and 15; Daunorubicin 30 mg/m2 IV, days 1, 2, 8 and 9; cyclophosphamide 600 mg/m2/day IV, days 1 and 15; Asparaginase: 10.000 UI/m2 IM or IV, days 1-3 and 15-17;intrathecally treatment days 1 and 15

Maintenance therapy 1:administration of continuous chemotherapy (mercaptopurine and methotrexate) and reinductions until one year from diagnosis.

Continuous chemotherapy:
- MP 50 mg/m2/day PO
- MTX 20 mg/m2/week IM
Reinductions
- VCR: 1,5 mg/m2 IV, day 1.
- PDN: 60 mg/m2/day, IV or PO days 1 to 7
- L-ASA: 20.000 UI/m2, IM or IV day 1.
- Intrathecally day 1

Seven cycles, weeks 25, 29, 33, 37, 41, 45 and 49.

Maintenance therapy 2:administration of continuous chemotherapy (mercaptopurine and methotrexate) while second year from diagnosis (weeks 53 to 104).

MP 50 mg/m2/day, PO
MTX 20 mg/m2/week, IM.

Study Type

Interventional

Enrollment (Actual)

374

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia Time Frame: 2 years	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Demonstrate that in this group of patients, the CNS relapse is not frequently and is not necessary cranial radiotherapy Time Frame: 2 years	2 years
To evaluate the treatment tolerance Time Frame: 1 year	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Investigators

Study Director: Ribera Josep Mª, Dr, Germans Trias i Pujol Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

Spanish association of Haematology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1996

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 29, 2007

First Submitted That Met QC Criteria