LAL-AR-N-2005:Study Treatment for Children High Risk Acute Lymphoblastic Leukemia

This study has been completed.
Information provided by (Responsible Party):
PETHEMA Foundation Identifier:
First received: September 6, 2007
Last updated: October 27, 2014
Last verified: October 2014

The study objective is to improve the global results obtained with LAL-AR-93 study, reaching an event free survival between 60-70%.

Identify patients with bad prognosis, with minimal residual disease,who can benefit of allogenic bone marrow transplantation

Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: Prednisolone
Drug: Daunorubicin
Drug: Vincristine
Drug: L-Asparaginase
Drug: Cyclophosphamide
Drug: Methotrexate
Drug: Cytosine Arabinoside
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LAL-AR-N-2005: Study Treatment for Children High Risk Acute Lymphoblastic Leukemia

Resource links provided by NLM:

Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • To improve the global results obtained in PETHEMA LAL-AR-93 study in terms of events free time [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2005
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Prednisolone
    Induction: 60 mg/m2/day, oral or i.v x 21 days and 30 mg/m2/day oral or iv x 7 days Reinduction-Intensification Treatment: 60 mg/m2/d x 14 days and 30 mg/m2/day oral x 7 days
    Drug: Daunorubicin
    Induction: 30 mg/m2, i.v, days 1, 8, 15, 22 Consolidation (Bloc II)30 mg/m2, i.v, day 1
    Drug: Vincristine
    Induction: 1,5 mg/m2 iv, days 1, 8, 15, 22 Consolidation (Bloc I):1,5 mg/m2 iv, days 1, 8 Consolidation (Bloc II):1,5 mg/m2 iv, days 1, 8 Reinduction: 1,5 mg/m2 iv, days 1, 8 Maintenance:1,5 mg/m2 iv, day 22
    Drug: L-Asparaginase
    Induction: 10.000 U/m2 im or iv, days 9,11,13,16,18,20,23,25,27 Consolidation (Bloc II): 20.000 U/m2 im or iv, day 7 Maintenance: 20.000 U/m2 im or iv, day 22
    Drug: Cyclophosphamide
    Induction: 500 mg/m2 iv, days 1, 2, 29 Consolidation (Bloc I): 500 mg/m2 iv, day 8 Reinduction:500 mg/m2 iv, day 15
    Drug: Methotrexate
    Consolidation (Bloc I): 5 g/m2 24 hours infusion Consolidation (Bloc II): 5 g/m2 24 hours infusion Reinduction: 3 g/m2 24 hours infusion Maintenance: 20 mg/m2/d, IM/week x 3 (1, 7, 14)
    Drug: Cytosine Arabinoside
    Consolidation (Bloc I): 1 g/m2/12 h iv, days 5, 6 Consolidation (Bloc II): 1 g/m2/12 h iv, days 5, 6 Reinduction: 1 g/m2/12 h iv, days 43, 44
  Show Detailed Description


Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • High risk children with acute lymphoblastic leukemia

Exclusion Criteria:

  • Mature B-ALL (FABL3)
  • Mixed forms of ALL
  • Patients with coronary disorders, valvular or hypertensive cardiopathy
  • Patients with chronic liver disorders
  • Chronic pulmonary disorders
  • Renal insufficiency
  • Neurologic disfunctions
  • ECOG 3 and 4
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00526409

Hospital materno Infantil vall d'Hebrón
Barcelona, Spain
Hospital Niño Jesús
Madrid, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Hospital Infantil Carlos Haya
Málaga, Spain
Sponsors and Collaborators
PETHEMA Foundation
Study Chair: Bastida Pilar, Dr Hospital Universitari Materno-Infantil Vall d'Hebron
Study Chair: Ribera Josep Mª, Dr Germans Trias i Pujol Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: PETHEMA Foundation Identifier: NCT00526409     History of Changes
Other Study ID Numbers: LAL-AR-N-2005
Study First Received: September 6, 2007
Last Updated: October 27, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 27, 2015