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

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ClinicalTrials.gov Identifier: NCT00526409
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation

Brief Summary:

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 or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: Prednisolone Drug: Daunorubicin Drug: Vincristine Drug: L-Asparaginase Drug: Cyclophosphamide Drug: Methotrexate Drug: Cytosine Arabinoside Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LAL-AR-N-2005: Study Treatment for Children High Risk Acute Lymphoblastic Leukemia
Study Start Date : June 2005
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014



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


Primary Outcome Measures :
  1. To improve the global results obtained in PETHEMA LAL-AR-93 study in terms of events free time [ Time Frame: 2 years ]


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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526409


Locations
Spain
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
Investigators
Study Chair: Bastida Pilar, Dr Hospital Universitari Materno-Infantil Vall d'Hebron
Study Chair: Ribera Josep Mª, Dr Germans Trias i Pujol Hospital

Additional Information:
Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00526409     History of Changes
Other Study ID Numbers: LAL-AR-N-2005
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014

Keywords provided by PETHEMA Foundation:
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Methotrexate
Cytarabine
Vincristine
Prednisolone
Daunorubicin
Asparaginase
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites