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

This study is currently recruiting participants.
Verified November 2013 by PETHEMA Foundation
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00526409
First received: September 6, 2007
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526409

Contacts
Contact: Bastida Pilar, Dr : 34-93- 4893093 pbastida@vhebron.es

Locations
Spain
Hospital materno Infantil vall d'Hebrón Recruiting
Barcelona, Spain
Hospital Niño Jesús Recruiting
Madrid, Spain
Hospital Virgen de la Arrixaca Recruiting
Murcia, Spain
Hospital Infantil Carlos Haya Recruiting
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 HOSPITAL GERMANS TRIAS I PUJOL
  More Information

Additional Information:
No publications provided

Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00526409     History of Changes
Other Study ID Numbers: LAL-AR-N-2005
Study First Received: September 6, 2007
Last Updated: November 19, 2013
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Asparaginase
Cyclophosphamide
Cytarabine
Daunorubicin
Methotrexate
Prednisolone
Methylprednisolone Hemisuccinate
Vincristine
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on April 23, 2014