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

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Asparaginase
Cyclophosphamide
Cytarabine
Daunorubicin
Mercaptopurine
Prednisone
Vincristine
Methotrexate
Intrathecally treatment
Sponsored by
PETHEMA Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Central de Asturias
  • Hospital Germans Trias i Pujol
  • Corporació Sanitària Parc Taulí
  • Hospital Mútua de Terrassa
  • Hospital general de Castellón
  • Hospital Verge de la Cinta
  • Complejo Hospitalario Universitario de Albacete
  • Hospital General de Alicante
  • Hospital Ntra. Sra. Sonsoles
  • Hospital Regional Universitario Infanta Cristina
  • Hospital Clínic
  • Hospital de la Santa Creu i Sant Pau
  • Hospital del Mar
  • Hospital vall d'Hebrón
  • Hospital Valle Hebrón-Materno Infantil
  • Basurtuko Ospitalea
  • Hospital Nuestra Señora de Alarcos
  • Hospital Virgen de la Luz
  • Complejo Hospitalario de Cáceres
  • Hospital Puerta del Mar
  • Complejo Hospitalario Reina Sofía
  • Hospital General de Elda
  • Institut Català d'Oncologia,
  • Hospital Universitario Virgen de las Nieves
  • Hospital Juan Ramón Jiménez
  • Hospital de San Jorge
  • Hospital Médico Quirúrgico Ciudad de Jaén
  • Hospital de Jerez de la Frontera
  • Hospital Juan Canalejo
  • Hospital General de Lanzarote
  • Complejo Hospitalario León
  • Hospital Arnau de Vilanova
  • Complexo Hospitalario Xeral-Calde
  • Clínica Puerta de Hierro
  • Hospital 12 de Octubre
  • Hospital Clínico San Carlos de Madrid
  • Hospital de Fuenlabrada
  • Hospital de la Princesa
  • Hospital Doce de Octubre
  • Hospital General Universitario Gregorio Marañón, Madrid
  • Hospital Puerta de Hierro
  • Hospital Ramón y Cajal
  • Hospital Universitario de la Princesa
  • Hospital Universitario La Paz
  • Hospital Universitario Princcipe de Asturias
  • Althaia, Xarxa Asistencial de Manresa
  • Hospital General Morales Meseguer
  • Hospital Santa María del Rosell
  • Hospital Virgen del Castillo de Yecla
  • . Hospital Clínico Universitario Virgen de la Victoria
  • H. Carlos Haya
  • Hospital del Río Carrión
  • Complejo Asistencial Son Dureta
  • Hospital Son Dureta
  • Hospital Son Llatzer
  • Hospital Verge del Toro
  • Clínica Universitaria de Navarra
  • Hospital Virgen del Camino
  • Complejo Hospitalario de Pontevedra_Hospital Montecelo
  • Hospital de Sagunto
  • Hospital Clínico de Salamanca
  • Hospital San Pedro de Alcántara
  • Clínica Sant Camil
  • Hospital Universitario Marqués de Valdecilla
  • Complejo Hospitalario Universitario de Santiago
  • Hospital de Santiago de Compostela
  • Hospital General de Segovia
  • H.U. Virgen del Rocio
  • Hospital Universitario Virgen del Rocío
  • Hospital Joan XXIII
  • Hospital Universitario de Canarias
  • Hospital Nuestra Señora del Prado
  • Hospital Virgen de la Salud
  • Fundación Instituto Valenciano de Oncología
  • Hospital Clínico Universitario de Valencia
  • Hospital Clínic
  • Hospital Dr. Peset
  • Hospital Francesc de Borja
  • Hospital General Básico de la Defensa
  • Hospital General Universitario
  • Hospital La Fe
  • Hospital Clínico de Valladolid
  • Complejo Hospitalario Universitario de Vigo
  • Hospital Meixoeiro
  • Hospital Txagorritxu
  • Hospital de Galdakao
  • Hospital Clínico Lozano Blesa

Outcomes

Primary Outcome Measures

Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia

Secondary Outcome Measures

Demonstrate that in this group of patients, the CNS relapse is not frequently and is not necessary cranial radiotherapy
To evaluate the treatment tolerance

Full Information

First Posted
June 29, 2007
Last Updated
May 15, 2009
Sponsor
PETHEMA Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00494897
Brief Title
PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia
Official Title
PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
June 1996 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
PETHEMA Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
374 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Asparaginase
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Type
Drug
Intervention Name(s)
Daunorubicin
Intervention Type
Drug
Intervention Name(s)
Mercaptopurine
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Procedure
Intervention Name(s)
Intrathecally treatment
Primary Outcome Measure Information:
Title
Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Demonstrate that in this group of patients, the CNS relapse is not frequently and is not necessary cranial radiotherapy
Time Frame
2 years
Title
To evaluate the treatment tolerance
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ribera Josep Mª, Dr
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Central de Asturias
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
Country
Spain
Facility Name
Corporació Sanitària Parc Taulí
City
Sabadell
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Mútua de Terrassa
City
Terrassa
State/Province
Barcelona
Country
Spain
Facility Name
Hospital general de Castellón
City
Castello
State/Province
Castellón
Country
Spain
Facility Name
Hospital Verge de la Cinta
City
Tortosa
State/Province
Tarragona
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Albacete
City
Albacete
Country
Spain
Facility Name
Hospital General de Alicante
City
Alicante
Country
Spain
Facility Name
Hospital Ntra. Sra. Sonsoles
City
Avila
Country
Spain
Facility Name
Hospital Regional Universitario Infanta Cristina
City
Badajoz
Country
Spain
Facility Name
Hospital Clínic
City
Barcelona
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital vall d'Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital Valle Hebrón-Materno Infantil
City
Barcelona
Country
Spain
Facility Name
Basurtuko Ospitalea
City
Basurto
Country
Spain
Facility Name
Hospital Nuestra Señora de Alarcos
City
Ciudad Real
Country
Spain
Facility Name
Hospital Virgen de la Luz
City
Cuenca
Country
Spain
Facility Name
Complejo Hospitalario de Cáceres
City
Cáceres
Country
Spain
Facility Name
Hospital Puerta del Mar
City
Cádiz
Country
Spain
Facility Name
Complejo Hospitalario Reina Sofía
City
Córdoba
Country
Spain
Facility Name
Hospital General de Elda
City
Elda
Country
Spain
Facility Name
Institut Català d'Oncologia,
City
Gerona
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
Country
Spain
Facility Name
Hospital Juan Ramón Jiménez
City
Huelva
Country
Spain
Facility Name
Hospital de San Jorge
City
Huesca
Country
Spain
Facility Name
Hospital Médico Quirúrgico Ciudad de Jaén
City
Jaen
Country
Spain
Facility Name
Hospital de Jerez de la Frontera
City
Jerez de la Frontera
Country
Spain
Facility Name
Hospital Juan Canalejo
City
La Coruña
Country
Spain
Facility Name
Hospital General de Lanzarote
City
Lanzarote
Country
Spain
Facility Name
Complejo Hospitalario León
City
Leon
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Lleida
Country
Spain
Facility Name
Complexo Hospitalario Xeral-Calde
City
Lugo
Country
Spain
Facility Name
Clínica Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Clínico San Carlos de Madrid
City
Madrid
Country
Spain
Facility Name
Hospital de Fuenlabrada
City
Madrid
Country
Spain
Facility Name
Hospital de la Princesa
City
Madrid
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón, Madrid
City
Madrid
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Princcipe de Asturias
City
Madrid
Country
Spain
Facility Name
Althaia, Xarxa Asistencial de Manresa
City
Manresa
Country
Spain
Facility Name
Hospital General Morales Meseguer
City
Murcia
Country
Spain
Facility Name
Hospital Santa María del Rosell
City
Murcia
Country
Spain
Facility Name
Hospital Virgen del Castillo de Yecla
City
Murcia
Country
Spain
Facility Name
. Hospital Clínico Universitario Virgen de la Victoria
City
Málaga
Country
Spain
Facility Name
H. Carlos Haya
City
Málaga
Country
Spain
Facility Name
Hospital del Río Carrión
City
Palencia
Country
Spain
Facility Name
Complejo Asistencial Son Dureta
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Son Dureta
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Son Llatzer
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Verge del Toro
City
Palma de Mallorca
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital Virgen del Camino
City
Pamplona
Country
Spain
Facility Name
Complejo Hospitalario de Pontevedra_Hospital Montecelo
City
Pontevedra
Country
Spain
Facility Name
Hospital de Sagunto
City
Sagunto
Country
Spain
Facility Name
Hospital Clínico de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital San Pedro de Alcántara
City
San Pedro de Alcántara
Country
Spain
Facility Name
Clínica Sant Camil
City
Sant Pere de Ribes
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital de Santiago de Compostela
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital General de Segovia
City
Segovia
Country
Spain
Facility Name
H.U. Virgen del Rocio
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Facility Name
Hospital Joan XXIII
City
Tarragona
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
Tenerife
Country
Spain
Facility Name
Hospital Nuestra Señora del Prado
City
Toledo
Country
Spain
Facility Name
Hospital Virgen de la Salud
City
Toledo
Country
Spain
Facility Name
Fundación Instituto Valenciano de Oncología
City
Valencia
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
Country
Spain
Facility Name
Hospital Clínic
City
Valencia
Country
Spain
Facility Name
Hospital Dr. Peset
City
Valencia
Country
Spain
Facility Name
Hospital Francesc de Borja
City
Valencia
Country
Spain
Facility Name
Hospital General Básico de la Defensa
City
Valencia
Country
Spain
Facility Name
Hospital General Universitario
City
Valencia
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Facility Name
Hospital Clínico de Valladolid
City
Valladolid
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo
City
Vigo
Country
Spain
Facility Name
Hospital Meixoeiro
City
Vigo
Country
Spain
Facility Name
Hospital Txagorritxu
City
Vitoria
Country
Spain
Facility Name
Hospital de Galdakao
City
Vizcaya
Country
Spain
Facility Name
Hospital Clínico Lozano Blesa
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

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Spanish association of Haematology

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

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