LAL-AR-N-2005:Study Treatment for Children High Risk Acute Lymphoblastic Leukemia
LAL-AR-N-2005
LAL-AR-N-2005: Study Treatment for Children High Risk Acute Lymphoblastic Leukemia
1 other identifier
interventional
40
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2005
Longer than P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 6, 2007
CompletedFirst Posted
Study publicly available on registry
September 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 28, 2014
October 1, 2014
9.3 years
September 6, 2007
October 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To improve the global results obtained in PETHEMA LAL-AR-93 study in terms of events free time
2 years
Interventions
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
Eligibility Criteria
You may qualify if:
- High risk children with acute lymphoblastic leukemia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hospital materno Infantil vall d'Hebrón
Barcelona, Spain
Hospital Niño Jesús
Madrid, Spain
Hospital Infantil Carlos Haya
Málaga, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bastida Pilar, Dr
Hospital Universitari Materno-Infantil Vall d'Hebron
- STUDY CHAIR
Ribera Josep Mª, Dr
Germans Trias i Pujol Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2007
First Posted
September 10, 2007
Study Start
June 1, 2005
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
October 28, 2014
Record last verified: 2014-10