Study Treatment for Children High Risk Acute Lymphoblastic Leukemia - Full Text View

Sponsored by:	PETHEMA Foundation
Information provided by:	PETHEMA Foundation
ClinicalTrials.gov Identifier:	NCT00526409

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 IV

MedlinePlus related topics: Leukemia, Childhood

Drug Information available for: Cyclophosphamide Prednisolone Prednisolone acetate Depo-medrol Vincristine Methotrexate Cytarabine hydrochloride Daunorubicin Daunorubicin hydrochloride Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Cytarabine Prednisolone Sodium Succinate Vincristine sulfate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone L-Asparaginase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	LAL-AR-N-2005: Study Treatment for Children High Risk Acute Lymphoblastic Leukemia

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:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Induction: 30 mg/m2, i.v, days 1, 8, 15, 22 Consolidation (Bloc II)30 mg/m2, i.v, day 1

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

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

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

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)

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 Infantil Carlos Haya	Recruiting
Málaga, Spain
Hospital Virgen de la Arrixaca	Recruiting
Murcia, Spain
Hospital Niño Jesús	Recruiting
Madrid, 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:

Pethema Foundation web This link exits the ClinicalTrials.gov site

Spanish association of Haematology This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	pethema ( Pethema )
Study ID Numbers:	LAL-AR-N-2005
Study First Received:	September 6, 2007
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00526409 History of Changes
Health Authority:	Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:

Acute Lymphoblastic Leukemia

Study placed in the following topic categories:

Anti-Inflammatory Agents
Antimetabolites
Daunorubicin
Leukemia, Lymphoid
Immunologic Factors
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Prednisolone acetate
Cyclophosphamide
Hormones
Anti-Bacterial Agents
Leukemia
Methotrexate
Lymphoma

Alkylating Agents
Cytarabine
Acute Lymphoblastic Leukemia
Methylprednisolone Hemisuccinate
Asparaginase
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Antineoplastic Agents, Hormonal
Methylprednisolone acetate
Vincristine
Antimitotic Agents
Folic Acid Antagonists
Glucocorticoids
Antiviral Agents
Immunosuppressive Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Daunorubicin
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Cyclophosphamide
Antibiotics, Antineoplastic
Hormones

Leukemia
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Cytarabine
Asparaginase
Immunoproliferative Disorders
Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators

ClinicalTrials.gov processed this record on May 07, 2009