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Acute Lymphoblastic LeukemiaPhase 4NCT00494897

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

A Phase 4 study testing Asparaginase, Cyclophosphamide and Cytarabine in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 87 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Acute Lymphoblastic Leukemia
What is being tested?
Asparaginase, Cyclophosphamide and Cytarabine
Type of treatment
Surgery or procedure
How many people
374 participants
Where
87 sitesSpain
Study dates
Jun 1996to Dec 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Adults (over 15 years) with ALL standard risk no prior antiblastic chemotherapy

Who cannot join

  • 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
Show all 10Show fewer
  • Renal insufficiency
  • Neurologic disfunctions
  • ECOG 3 and 4
  • No signed consent form

Trial locations and contacts

87 sites in 1 country.

87 sites in 1 country

Spain87 sites

  • Hospital Juan Canalejo

    A Coruña, La Coruña

  • Complejo Hospitalario Universitario de Albacete

    Albacete

  • Hospital General de Alicante

    Alicante, Alicante

  • Hospital Ntra. Sra. Sonsoles

    Ávila, Avila

  • Hospital Regional Universitario Infanta Cristina

    Badajoz

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona

  • Hospital Clínic

    Barcelona, Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona

  • Hospital del Mar

    Barcelona, Barcelona

  • Hospital vall d'Hebrón

    Barcelona, Barcelona

  • Hospital Valle Hebrón-Materno Infantil

    Barcelona, Barcelona

  • Basurtuko Ospitalea

    Basurto

  • Complejo Hospitalario de Cáceres

    Cáceres

  • Hospital Puerta del Mar

    Cadiz, Cádiz

  • Hospital general de Castellón

    Castelló, Castellón

  • Hospital Nuestra Señora de Alarcos

    Ciudad Real

  • Complejo Hospitalario Reina Sofía

    Córdoba, Córdoba

  • Hospital Virgen de la Luz

    Cuenca

  • Hospital General de Elda

    Elda

  • Institut Català d'Oncologia,

    Girona

  • Hospital Universitario Virgen de las Nieves

    Granada, Granada

  • Hospital Juan Ramón Jiménez

    Huelva, Huelva

  • Hospital de San Jorge

    Huesca

  • Hospital Médico Quirúrgico Ciudad de Jaén

    Jaén, Jaen

  • Hospital de Jerez de la Frontera

    Jerez de la Frontera

  • Hospital General de Lanzarote

    Lanzarote

  • Complejo Hospitalario León

    León

  • Hospital Arnau de Vilanova

    Lleida, Lleida

  • Complexo Hospitalario Xeral-Calde

    Lugo

  • Clínica Puerta de Hierro

    Madrid, Madrid

  • Hospital Clínico San Carlos de Madrid

    Madrid, Madrid

  • Hospital de Fuenlabrada

    Madrid, Madrid

  • Hospital General Universitario Gregorio Marañón, Madrid

    Madrid, Madrid

  • Hospital Universitario de la Princesa

    Madrid, Madrid

  • Hospital Universitario Princcipe de Asturias

    Madrid, Madrid

  • Hospital 12 de Octubre

    Madrid

  • Hospital de la Princesa

    Madrid

  • Hospital Doce de Octubre

    Madrid

  • Hospital Puerta de Hierro

    Madrid

  • Hospital Ramón y Cajal

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • . Hospital Clínico Universitario Virgen de la Victoria

    Málaga, Málaga

  • H. Carlos Haya

    Málaga

  • Althaia, Xarxa Asistencial de Manresa

    Manresa

  • Hospital General Morales Meseguer

    Murcia

  • Hospital Santa María del Rosell

    Murcia

  • Hospital Virgen del Castillo de Yecla

    Murcia

  • Hospital Central de Asturias

    Oviedo, Principality of Asturias

  • Hospital del Río Carrión

    Palencia, Palencia

  • Hospital Son Dureta

    Palma de Mallorca, Palma de Mallorca

  • Complejo Asistencial Son Dureta

    Palma de Mallorca

  • Hospital Son Llatzer

    Palma de Mallorca

  • Hospital Verge del Toro

    Palma de Mallorca

  • Clínica Universitaria de Navarra

    Pamplona

  • Hospital Virgen del Camino

    Pamplona

  • Complejo Hospitalario de Pontevedra_Hospital Montecelo

    Pontevedra

  • Corporació Sanitària Parc Taulí

    Sabadell, Barcelona

  • Hospital de Sagunto

    Sagunto

  • Hospital Clínico de Salamanca

    Salamanca

  • Hospital San Pedro de Alcántara

    San Pedro

  • Clínica Sant Camil

    Sant Pere de Ribes

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife

  • Hospital Universitario Marqués de Valdecilla

    Santander

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela

  • Hospital de Santiago de Compostela

    Santiago de Compostela

  • Hospital General de Segovia

    Segovia

  • Hospital Universitario Virgen del Rocío

    Seville, Sevilla

  • H.U. Virgen del Rocio

    Seville

  • Hospital Joan XXIII

    Tarragona, Tarragona

  • Hospital Mútua de Terrassa

    Terrassa, Barcelona

  • Hospital Nuestra Señora del Prado

    Toledo

  • Hospital Virgen de la Salud

    Toledo

  • Hospital Verge de la Cinta

    Tortosa, Tarragona

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia

  • Hospital Clínic

    Valencia, Valencia

  • Hospital General Universitario

    Valencia, Valencia

  • Hospital La Fe

    Valencia, Valencia

  • Fundación Instituto Valenciano de Oncología

    Valencia

  • Hospital Dr. Peset

    Valencia

  • Hospital Francesc de Borja

    Valencia

  • Hospital General Básico de la Defensa

    Valencia

  • Hospital Clínico de Valladolid

    Valladolid

  • Hospital Meixoeiro

    Vigo, Vigo

  • Complejo Hospitalario Universitario de Vigo

    Vigo

  • Hospital Txagorritxu

    Vitoria-Gasteiz

  • Hospital de Galdakao

    Vizcaya

  • Hospital Clínico Lozano Blesa

    Zaragoza, Zaragoza

Other trials in Spain

About this study

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.

Read the 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.
Being tested
Asparaginase, Cyclophosphamide, Cytarabine, Daunorubicin, Mercaptopurine
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia

    Measured: 2 years

Secondary outcomes (2)

  1. Demonstrate that in this group of patients, the CNS relapse is not frequently and is not necessary cranial radiotherapy

    Measured: 2 years

  2. To evaluate the treatment tolerance

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2007 (estimated)
  2. Study startJun 1996
  3. Primary completionMay 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00494897
Sponsor's protocol ID
LAL-RI/96
Status last verified
May 2009
First submitted
29 Jun 2007
Last updated
19 May 2009
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 10556184

  • 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.

    PubMed 2189958

  • 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.

    PubMed 2649141

  • 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.

    PubMed 2182430

  • 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.

    PubMed 2009234

  • 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.

    PubMed 1941059

  • 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.

    PubMed 2033963

  • 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.

    PubMed 1578934

  • 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.

    PubMed 1578929

  • 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.

    PubMed 8361217

  • 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.

    PubMed 8410124

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Asparaginase, Cyclophosphamide and Cytarabine in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 87 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00494897, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2009.

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