Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults
- Conditions
- Acute Lymphoblastic Leukemia
- Interventions
- Drug: Pediatric-type of chemotherapyProcedure: allogeneic HSCT
- Registration Number
- NCT04179929
- Lead Sponsor
- PETHEMA Foundation
- 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.
- Detailed Description
Patients will be uniformly treated with four drug-induction: vincristine (VCR), prednisone (PDN), pegylated asparaginase (PegASP), daunorubicin (DNR).
Resistant patients will receive a second induction with fludarabine, Ara-C, G-Colony-Stimulating Factor (G-CSF) and idarubicin (FLAG-IDA).
Patients with adequate MRD clearance after induction will receive 3 blocks of early consolidation. If adequate MRD clearance and good genetic background, the patients will proceed to delayed intensification, reinduction and maintenance. The remaining patients will receive early or delayed alloHSCT.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CHEMOTHERAPY Pediatric-type of chemotherapy Pediatric-type of chemotherapy allogeneic HSCT allogeneic HSCT allogeneic HSCT
- Primary Outcome Measures
Name Time Method Overall survival 3 years Time from diagnosis to death or last follow-up
- Secondary Outcome Measures
Name Time Method Complete remission (CR) rate 4 or 8 weeks after treatment onset Proportion of patients who achieve CR with or 2 induction therapy lines
MRD status after induction and consolidation After induction (4-8 weeks) and consolidation (16-20 weeks) Proportion of patients who achieve and maintain the negative MRD status (\<10-4)
Trial Locations
- Locations (83)
ICO-Duran i Reynals
🇪🇸Bellvitge, Spain
H. Clínic de Barcelona
🇪🇸Barcelona, Spain
H. General Univ. de Alicante
🇪🇸Alicante, Spain
H Albacete
🇪🇸Albacete, Spain
H del Mar
🇪🇸Barcelona, Spain
H. Sant Pau
🇪🇸Barcelona, Spain
H. General de Castellón
🇪🇸Castelló, Spain
H. Reina Sofía
🇪🇸Córdoba, Spain
ICO-Dr.Josep Trueta
🇪🇸Girona, Spain
H. General Lanzarote
🇪🇸Lanzarote, Spain
Hospital Insular de Gran Canaria
🇪🇸Las Palmas De Gran Canaria, Spain
H. 12 de Octubre
🇪🇸Madrid, Spain
H Puerta de Hierro
🇪🇸Madrid, Spain
H. Regional de Málaga
🇪🇸Málaga, Spain
H. Univ La Paz
🇪🇸Madrid, Spain
Hu La Princesa
🇪🇸Madrid, Spain
H. Infanta Sofía
🇪🇸Madrid, Spain
H. Carlos Haya
🇪🇸Málaga, Spain
H. Clínico Univ. de Navarra
🇪🇸Pamplona, Spain
H. Virgen del Camino
🇪🇸Pamplona, Spain
H. Son Espases
🇪🇸Palma De Mallorca, Spain
H. Parc Taulí
🇪🇸Sabadell, Spain
H. Clínico Univ. de Salamanca
🇪🇸Salamanca, Spain
H Donostia
🇪🇸San Sebastián, Spain
H. Dr. Peset
🇪🇸Valencia, Spain
H Torrejón
🇪🇸Torrejón De Ardoz, Spain
H. Río Hortega
🇪🇸Valladolid, Spain
H. Arnau de Vilanova
🇪🇸Valencia, Spain
H. Clínico Univ. de Valencia
🇪🇸Valencia, Spain
Mútua de Terrassa
🇪🇸Terrassa, Spain
H. la Fe
🇪🇸Valencia, Spain
H. General Univ. de Valencia
🇪🇸Valencia, Spain
H. Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Hospital Nuestra Señora de Sonsoles
🇪🇸Ávila, Spain
H Basurto
🇪🇸Bilbao, Spain
H. Jerez
🇪🇸Cadiz, Spain
H. Puerta del Mar
🇪🇸Cadiz, Spain
H. Fuenlabrada
🇪🇸Fuenlabrada, Spain
H Galdakao
🇪🇸Galdakao, Spain
H. Univ. De Getafe
🇪🇸Getafe, Spain
H Juan Ramón Jiménez
🇪🇸Huelva, Spain
Complejo Hospitalario Ciudad de Jaén
🇪🇸Jaén, Spain
H. Guadalajara
🇪🇸Guadalajara, Spain
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
H. A Coruña
🇪🇸La Coruña, Spain
H. Arnau De Vilanova
🇪🇸Lleida, Spain
H La Zarzuela
🇪🇸Madrid, Spain
H. Gregorio Marañón
🇪🇸Madrid, Spain
H. Madrid-Norte Sanchinarro
🇪🇸Madrid, Spain
H. Ramón y Cajal
🇪🇸Madrid, Spain
H. Central de Asturias
🇪🇸Oviedo, Spain
Hu Infanta Leonor
🇪🇸Madrid, Spain
H. Morales Meseguer
🇪🇸Murcia, Spain
H. Marqués de Valdecilla
🇪🇸Santander, Spain
H. Virgen de la Arrixaca
🇪🇸Murcia, Spain
H. Univ. de Canarias
🇪🇸Santa Cruz De Tenerife, Spain
H. General de Segovia
🇪🇸Segovia, Spain
H. Virgen de la Concha
🇪🇸Zamora, Spain
Ico-Hugtip
🇪🇸Badalona, Barcelona, Spain
Clínica Teknon
🇪🇸Barcelona, Spain
H. del Mar
🇪🇸Barcelona, Spain
H. Vall d'Hebron
🇪🇸Barcelona, Spain
H. San Pedro de Alcántara
🇪🇸Cáceres, Spain
Hu Basurto
🇪🇸Bilbao, Spain
H. Jerez de la Frontera
🇪🇸Jerez De La Frontera, Spain
H Dr. Negrín
🇪🇸Las Palmas De Gran Canaria, Spain
H. Lucus Augusti
🇪🇸Lugo, Spain
H. Clínico de Madrid
🇪🇸Madrid, Spain
H. Clínico Univ. Virgen de la Victoria
🇪🇸Málaga, Spain
H. Son Llàtzer
🇪🇸Palma De Mallorca, Spain
Complejo Hosp. Univ. de Orense
🇪🇸Orense, Spain
Complejo Hospitalario Navarra
🇪🇸Pamplona, Spain
H Río Carrión
🇪🇸Palencia, Spain
Complejo Hospitalario Pontevedra - Hospital Montecelo
🇪🇸Pontevedra, Spain
Complejo Hosp. Univ. Santiago de Compostela
🇪🇸Santiago De Compostela, Spain
H. Virgen del Rocío
🇪🇸Sevilla, Spain
ICO-Joan XXIII
🇪🇸Tarragona, Spain
H. Universitario de Valme
🇪🇸Sevilla, Spain
H. Verge de la Cinta
🇪🇸Tortosa, Spain
H. Xeral-Cíes Vigo
🇪🇸Vigo, Spain
H. Lozano Blesa
🇪🇸Zaragoza, Spain
Hu Gran Canarias Dr Negrin
🇪🇸Las Palmas De Gran Canaria, Spain
H. Miguel Servet
🇪🇸Zaragoza, Spain