Treatment of High Risk Adult Acute Lymphoblastic Leukemia
LAL-AR/2003
1 other identifier
interventional
100
1 country
38
Brief Summary
Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in HR Ph- adult ALL patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2003
Longer than P75 for phase_4
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 25, 2009
CompletedFirst Posted
Study publicly available on registry
February 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedApril 7, 2020
April 1, 2020
9.8 years
February 25, 2009
April 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels in HR Ph- adult ALL patients.
2 years
Interventions
Vincristine (VCR): 1.5 mg/m2 (max 2 mg) IV d 1, 8, 15, 22 in induction VCR 2 mg, IV, d 1,8 in consolidation (cycle 1, 2)
Daunorubicin (DNR): 60 mg/m2 IV d 1, 8, 15, 22
Prednisone (PDN): 60 mg/m2/d IV or PO, d 1-28
Mitoxantrone:12 mg/m2, IV d 15-17 in induction 12 mg/m2, IV,d 5 in cycle 2 consolidation
ARA-C 2,000 mg/m2/12h IV, d18,19 (4 doses) in induction
Dexamethasone 20 mg/m2,IV, d 1-5,10 mg/m2,IV, d 6 and 5 mg/m2,IV, d 7 in Consolidation (3 cycles)
Methotrexate (MTX)3 g/m2,IV, d1 (24h)in consolidation, cycles 1 and 2 MTX (15 mg/m2/wk, IM)in maintenance MTX 15 mg, IT
Cytarabine 2g/m2/12h, IV d5 in cycle 1 consolidation Cytarabine 2g/m2/12h, IV d 1,2 in cycle 3 consolidation Cytarabine 30 mg, intrathecal
ASP 25,000 IU/m2, IV, d5 in consolidation (cycle 1, 2, 3)
Mercaptopurine 100 mg/m2, PO, d 1-5 in consolidation
Teniposide 150 mg/m2, IV d 3,4 in consolidation cycle 3
Hydrocortisone 20 mg, IT d 1, 28, 49, 77, 105, 175, 203, 231, 259,287, 311 intrathecal
Eligibility Criteria
You may qualify if:
- High risk ALL adult patients (age\> 15 years)no treated previously
- High-risk ALL:
- One or more of the following:
- Age 30-60 yr.
- WBC count \>25x109/L
- q23 or ALL1/AF4
- Very high-risk ALL:
- HR ALL and one or the following:
- Slow cytologic response (\>10% blasts in BM on d14 of induction therapy).
- MRD\>0.05% (by flow cytometry) at the end of consolidation
You may not qualify if:
- L3 ALL or B mature(sIg +) or t(8;14), t(2;8), t(8;22).
- ALL Ph (BCR/ABL) positive.
- Bifenotipics ALL as EGIL criteria.
- Indifferentiated ALL.
- Patients with cardiac pathology
- Patients with chronic liver disease in activity fase
- Pulmonary disease
- Renal insufficiency not due to ALL
- Neurological disorders not due to ALL
- PS (grades 3 and 4) not due to ALL.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Hospital Juan Canalejo
A Coruña, Spain
Hospital General
Alicante, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Clínica Teknon
Barcelona, Spain
Hospital Clínic i Provincial
Barcelona, Spain
Hospital de Sant Pau
Barcelona, Spain
Hospital Duran y Reynals
Barcelona, Spain
Hospital Vall d'Hebrón
Barcelona, Spain
Hospital Puerta del Mar
Cadiz, Spain
Hospital General
Castellon, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital Josep Trueta
Girona, Spain
Hospital Universitario
Guadalajara, Spain
Hospital Xeral
Lugo, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico Universitario
Madrid, Spain
Hospital de Fuenlabrada
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Carlos Haya
Málaga, Spain
Hospital Virgen de la Victoria
Málaga, Spain
Hospital Morales Messeguer
Murcia, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Son Llàtzer
Palma de Mallorca, Spain
Clínica Universitaria de Navarra
Pamplona, Spain
Hospital Parc Taulí
Sabadell, Spain
Hospital Clínico Universitario
Salamanca, Spain
Hospital Marqués de Valdecilla
Santander, Spain
Hospital Xeral
Santiago, Spain
Hospital Virgen del Rocio
Seville, Spain
Hospital Joan XXIII
Tarragona, Spain
Hospital Mútua de Terrassa
Terrassa, Spain
Hospital Clínico Universitario
Valencia, Spain
Hospital Dr Pesset
Valencia, Spain
Hospital General
Valencia, Spain
Hospital La Fe
Valencia, Spain
Hospital Clínico
Valladolid, Spain
Hospital Virgen de la Concha
Zamora, Spain
Hospital Lozano Blesa
Zaragoza, Spain
Related Publications (1)
Ribera JM, Oriol A, Morgades M, Montesinos P, Sarra J, Gonzalez-Campos J, Brunet S, Tormo M, Fernandez-Abellan P, Guardia R, Bernal MT, Esteve J, Barba P, Moreno MJ, Bermudez A, Cladera A, Escoda L, Garcia-Boyero R, Del Potro E, Bergua J, Amigo ML, Grande C, Rabunal MJ, Hernandez-Rivas JM, Feliu E. Treatment of high-risk Philadelphia chromosome-negative acute lymphoblastic leukemia in adolescents and adults according to early cytologic response and minimal residual disease after consolidation assessed by flow cytometry: final results of the PETHEMA ALL-AR-03 trial. J Clin Oncol. 2014 May 20;32(15):1595-604. doi: 10.1200/JCO.2013.52.2425. Epub 2014 Apr 21.
PMID: 24752047DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ribera Josep Mª, Dr
PETHEMA Foundation
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2009
First Posted
February 27, 2009
Study Start
January 1, 2003
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
April 7, 2020
Record last verified: 2020-04