Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults
Treatment of BCR-ABL Negative ALL in Adults According to MRD and Genetics
1 other identifier
interventional
300
1 country
108
Brief Summary
After consolidation therapy adult patients (≥18 yr) with Ph-negative ALL will be treated with continuation chemotherapy or allogeneic hematopoietic stem cell transplantation (alloHSCT) according to both measurable residual disease (MRD) and results of genetic study performed at baseline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
Longer than P75 for not_applicable
108 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
First Submitted
Initial submission to the registry
November 20, 2019
CompletedStudy Start
First participant enrolled
November 25, 2019
CompletedFirst Posted
Study publicly available on registry
November 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
February 18, 2022
February 1, 2022
6.9 years
November 20, 2019
February 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Time from diagnosis to death or last follow-up
3 years
Secondary Outcomes (2)
Complete remission (CR) rate
4 or 8 weeks after treatment onset
MRD status after induction and consolidation
After induction (4-8 weeks) and consolidation (16-20 weeks)
Other Outcomes (1)
alloSCT realization
Early alloHSCT: 15-20 weeks from diagnosis. Delayed: 30-35 weeks from diagnosis.
Study Arms (2)
CHEMOTHERAPY
OTHERPediatric-type of chemotherapy
allogeneic HSCT
OTHERallogeneic HSCT
Interventions
Pediatric type chemotherapy (induction, early and delayed consolidation, reinduction, maintenance). Induction (VCR,PDN,PegASP,DNR). Early and delayed consolidation (high-dose Methotrexate, high-dose Cytarabine, PegASP). Reinduction (VCR, PDN, PegASP, DNR). Maintenance (Methotrexate, Mercaptopurine)
Eligibility Criteria
You may qualify if:
- Patients 18-60 yr with de novo Ph-neg ALL
- Eastern Cooperative Oncology Group (ECOG) 0-2 (or \>2 if due to ALL)
- Informed consent
You may not qualify if:
- Mature B-ALL, Ph+ ALL or blast crisis of chronic myeloid leukemia (CML), ALL of ambiguous lineage
- ECOG \>2 not due to ALL
- Impaired cardiac, respiratory, hepatic or renal function not due to ALL
- Pregnancy
- HIV positivity
- Severe psychiatric disease
- Negative to sign informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (108)
Ico-Hugtip
Badalona, Barcelona, 08916, Spain
H. A Coruña
A Coruña, Spain
H Albacete
Albacete, Spain
H. General Univ. de Alicante
Alicante, Spain
H. General Univ. de Alicante
Alicante, Spain
Hospital Nuestra Señora de Sonsoles
Ávila, Spain
Clínica Teknon
Barcelona, Spain
H del Mar
Barcelona, Spain
H. Clínic de Barcelona
Barcelona, Spain
H. del Mar
Barcelona, Spain
H. Sant Pau
Barcelona, Spain
H. Vall d'Hebron
Barcelona, Spain
H. Vall d'Hebron
Barcelona, Spain
ICO-Duran i Reynals
Bellvitge, Spain
H Basurto
Bilbao, Spain
Hu Basurto
Bilbao, Spain
H. Jerez
Cadiz, Spain
H. Puerta del Mar
Cadiz, Spain
H. General de Castellón
Castelló, Spain
H. San Pedro de Alcántara
Cáceres, Spain
H. Reina Sofía
Córdoba, Spain
H. Fuenlabrada
Fuenlabrada, Spain
H Galdakao
Galdakao, Spain
H. Univ. De Getafe
Getafe, Spain
ICO-Dr.Josep Trueta
Girona, Spain
H. Guadalajara
Guadalajara, Spain
H Juan Ramón Jiménez
Huelva, Spain
Complejo Hospitalario Ciudad de Jaén
Jaén, Spain
H. Jerez de la Frontera
Jerez de la Frontera, Spain
H. General Lanzarote
Lanzarote, Spain
H Dr. Negrín
Las Palmas de Gran Canaria, Spain
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, Spain
Hu Gran Canarias Dr Negrin
Las Palmas de Gran Canaria, Spain
H. Arnau De Vilanova
Lleida, Spain
H. Lucus Augusti
Lugo, Spain
H. Lucus Augusti
Lugo, Spain
H. Lucus Augusti
Lugo, Spain
Fundación Jiménez Díaz
Madrid, Spain
H La Zarzuela
Madrid, Spain
H Puerta de Hierro
Madrid, Spain
H Puerta de Hierro
Madrid, Spain
H. 12 de Octubre
Madrid, Spain
H. 12 de Octubre
Madrid, Spain
H. 12 de Octubre
Madrid, Spain
H. 12 de Octubre
Madrid, Spain
H. 12 de Octubre
Madrid, Spain
H. Clínico de Madrid
Madrid, Spain
H. Clínico de Madrid
Madrid, Spain
H. Gregorio Marañón
Madrid, Spain
H. Gregorio Marañón
Madrid, Spain
H. Infanta Sofía
Madrid, Spain
H. Madrid-Norte Sanchinarro
Madrid, Spain
H. Ramón y Cajal
Madrid, Spain
H. Ramón y Cajal
Madrid, Spain
H. Univ La Paz
Madrid, Spain
Hu Infanta Leonor
Madrid, Spain
Hu La Princesa
Madrid, Spain
H. Carlos Haya
Málaga, Spain
H. Clínico Univ. Virgen de la Victoria
Málaga, Spain
H. Regional de Málaga
Málaga, Spain
H. Morales Meseguer
Murcia, Spain
H. Virgen de la Arrixaca
Murcia, Spain
H. Virgen de la Arrixaca
Murcia, Spain
H. Virgen de la Arrixaca
Murcia, Spain
Complejo Hosp. Univ. de Orense
Ourense, Spain
Complejo Hosp. Univ. de Orense
Ourense, Spain
Complejo Hosp. Univ. de Orense
Ourense, Spain
Complejo Hosp. Univ. de Orense
Ourense, Spain
H. Central de Asturias
Oviedo, Spain
H Río Carrión
Palencia, Spain
H. Son Espases
Palma de Mallorca, Spain
H. Son Llàtzer
Palma de Mallorca, Spain
Complejo Hospitalario Navarra
Pamplona, Spain
H. Clínico Univ. de Navarra
Pamplona, Spain
H. Virgen del Camino
Pamplona, Spain
Complejo Hospitalario Pontevedra - Hospital Montecelo
Pontevedra, Spain
H. Parc Taulí
Sabadell, Spain
H. Clínico Univ. de Salamanca
Salamanca, Spain
H. Clínico Univ. de Salamanca
Salamanca, Spain
H Donostia
San Sebastián, Spain
H Donostia
San Sebastián, Spain
H Donostia
San Sebastián, Spain
H Donostia
San Sebastián, Spain
H. Univ. de Canarias
Santa Cruz de Tenerife, Spain
H. Marqués de Valdecilla
Santander, Spain
H. Marqués de Valdecilla
Santander, Spain
Complejo Hosp. Univ. Santiago de Compostela
Santiago de Compostela, Spain
Complejo Hosp. Univ. Santiago de Compostela
Santiago de Compostela, Spain
H. General de Segovia
Segovia, Spain
H. Universitario de Valme
Seville, Spain
H. Virgen del Rocío
Seville, Spain
ICO-Joan XXIII
Tarragona, Spain
Mútua de Terrassa
Terrassa, Spain
H Torrejón
Torrejón de Ardoz, Spain
H. Verge de la Cinta
Tortosa, Spain
H. Arnau de Vilanova
Valencia, Spain
H. Clínico Univ. de Valencia
Valencia, Spain
H. Dr. Peset
Valencia, Spain
H. Dr. Peset
Valencia, Spain
H. General Univ. de Valencia
Valencia, Spain
H. la Fe
Valencia, Spain
H. Clínico Universitario de Valladolid
Valladolid, Spain
H. Río Hortega
Valladolid, Spain
H. Xeral-Cíes Vigo
Vigo, Spain
H. Xeral-Cíes Vigo
Vigo, Spain
H. Virgen de la Concha
Zamora, Spain
H. Lozano Blesa
Zaragoza, Spain
H. Miguel Servet
Zaragoza, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2019
First Posted
November 27, 2019
Study Start
November 25, 2019
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
February 18, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share