Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHEMOTHERAPY | Other | Pediatric-type of chemotherapy |
|
| allogeneic HSCT | Other | allogeneic HSCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pediatric-type of chemotherapy | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from diagnosis to death or last follow-up | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission (CR) rate | Proportion of patients who achieve CR with or 2 induction therapy lines | 4 or 8 weeks after treatment onset |
| MRD status after induction and consolidation | Proportion of patients who achieve and maintain the negative MRD status (<10-4) |
| Measure | Description | Time Frame |
|---|---|---|
| alloSCT realization | Proportion of patients who receive early or delayed alloHSCT | Early alloHSCT: 15-20 weeks from diagnosis. Delayed: 30-35 weeks from diagnosis. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josep Maria Ribera, Ph | Contact | 934978987 | jribera@iconcologia.net |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ico-Hugtip | Recruiting | Badalona | Barcelona | 08916 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42081455 | Derived | Ribera JM, Torrent A, Morgades M, Barrena S, Ribera J, Genesca E, Gonzalez-Campos J, Martinez-Cibrian N, Montesinos P, Hernandez Sanchez A, Barba P, Zapico E Sr, Sanchez R, Novo A, Sitges M, Maluquer Artigal C, Such E, Botella C, Queipo de Llano MP, Cabrero M, Vicent A, Lopez de Ugarriza P, Tormo M, Gonzalez-Gonzalez BJ, Garcia-Cadenas I, Rodriguez-Medina C, Martinez Sanchez P, Bermudez A, Gomez-Centurion I, Herrero-Garcia M, Ciudad J, Navas-Acosta J, Hermosin L, Serrano J, Raposo-Puglia JA, Solan L, Roldan-Galiacho V, de Laiglesia A, Gomez-Perez L, Sole-Rodriguez M, Casado MS Sr, Llorente Gonzalez L, Barrios Decoud D, Vall-Llovera F, Algarra JL, Amador L, Garcia-Boyero R, Cladera A, Bergua Burgues JM, Calasanz MJJ, Granada I, Feliu E, Hernandez-Rivas JM, Orfao A. Genetics and MRD for therapy allocation in adults with Philadelphia chromosome-negative acute lymphoblastic leukemia. Blood. 2026 May 4:blood.2025032645. doi: 10.1182/blood.2025032645. Online ahead of print. |
| Label | URL |
|---|---|
| Web page of the sponsor of the study | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| allogeneic HSCT | Procedure | allogeneic HSCT |
|
| After induction (4-8 weeks) and consolidation (16-20 weeks) |
| H. A Coruña | Not yet recruiting | A Coruña | Spain |
|
| H Albacete | Not yet recruiting | Albacete | Spain |
|
| H. General Univ. de Alicante | Recruiting | Alicante | Spain |
|
| H. General Univ. de Alicante | Not yet recruiting | Alicante | Spain |
|
| Hospital Nuestra Señora de Sonsoles | Recruiting | Ávila | Spain |
|
| Clínica Teknon | Not yet recruiting | Barcelona | Spain |
|
| H del Mar | Not yet recruiting | Barcelona | Spain |
|
| H. Clínic de Barcelona | Recruiting | Barcelona | Spain |
|
| H. del Mar | Not yet recruiting | Barcelona | Spain |
|
| H. Sant Pau | Recruiting | Barcelona | Spain |
|
| H. Vall d'Hebron | Recruiting | Barcelona | Spain |
|
| H. Vall d'Hebron | Not yet recruiting | Barcelona | Spain |
|
| ICO-Duran i Reynals | Not yet recruiting | Bellvitge | Spain |
|
| H Basurto | Not yet recruiting | Bilbao | Spain |
|
| Hu Basurto | Recruiting | Bilbao | Spain |
|
| H. Jerez | Not yet recruiting | Cadiz | Spain |
|
| H. Puerta del Mar | Not yet recruiting | Cadiz | Spain |
|
| H. General de Castellón | Not yet recruiting | Castelló | Spain |
|
| H. San Pedro de Alcántara | Not yet recruiting | Cáceres | Spain |
|
| H. Reina Sofía | Not yet recruiting | Córdoba | Spain |
|
| H. Fuenlabrada | Not yet recruiting | Fuenlabrada | Spain |
|
| H Galdakao | Not yet recruiting | Galdakao | Spain |
|
| H. Univ. De Getafe | Not yet recruiting | Getafe | Spain |
|
| ICO-Dr.Josep Trueta | Recruiting | Girona | Spain |
|
| H. Guadalajara | Not yet recruiting | Guadalajara | Spain |
|
| H Juan Ramón Jiménez | Not yet recruiting | Huelva | Spain |
|
| Complejo Hospitalario Ciudad de Jaén | Recruiting | Jaén | Spain |
|
| H. Jerez de la Frontera | Recruiting | Jerez de la Frontera | Spain |
|
| H. General Lanzarote | Not yet recruiting | Lanzarote | Spain |
|
| H Dr. Negrín | Recruiting | Las Palmas de Gran Canaria | Spain |
|
| Hospital Insular de Gran Canaria | Not yet recruiting | Las Palmas de Gran Canaria | Spain |
|
| Hu Gran Canarias Dr Negrin | Not yet recruiting | Las Palmas de Gran Canaria | Spain |
|
| H. Arnau De Vilanova | Recruiting | Lleida | Spain |
|
| H. Lucus Augusti | Not yet recruiting | Lugo | Spain |
|
| H. Lucus Augusti | Not yet recruiting | Lugo | Spain |
|
| H. Lucus Augusti | Not yet recruiting | Lugo | Spain |
|
| Fundación Jiménez Díaz | Not yet recruiting | Madrid | Spain |
|
| H La Zarzuela | Not yet recruiting | Madrid | Spain |
|
| H Puerta de Hierro | Recruiting | Madrid | Spain |
|
| H Puerta de Hierro | Not yet recruiting | Madrid | Spain |
|
| H. 12 de Octubre | Not yet recruiting | Madrid | Spain |
|
| H. 12 de Octubre | Not yet recruiting | Madrid | Spain |
|
| H. 12 de Octubre | Not yet recruiting | Madrid | Spain |
|
| H. 12 de Octubre | Not yet recruiting | Madrid | Spain |
|
| H. 12 de Octubre | Not yet recruiting | Madrid | Spain |
|
| H. Clínico de Madrid | Not yet recruiting | Madrid | Spain |
|
| H. Clínico de Madrid | Not yet recruiting | Madrid | Spain |
|
| H. Gregorio Marañón | Not yet recruiting | Madrid | Spain |
|
| H. Gregorio Marañón | Not yet recruiting | Madrid | Spain |
|
| H. Infanta Sofía | Not yet recruiting | Madrid | Spain |
|
| H. Madrid-Norte Sanchinarro | Recruiting | Madrid | Spain |
|
| H. Ramón y Cajal | Recruiting | Madrid | Spain |
|
| H. Ramón y Cajal | Not yet recruiting | Madrid | Spain |
|
| H. Univ La Paz | Not yet recruiting | Madrid | Spain |
|
| Hu Infanta Leonor | Not yet recruiting | Madrid | Spain |
|
| Hu La Princesa | Not yet recruiting | Madrid | Spain |
|
| H. Carlos Haya | Not yet recruiting | Málaga | Spain |
|
| H. Clínico Univ. Virgen de la Victoria | Recruiting | Málaga | Spain |
|
| H. Regional de Málaga | Recruiting | Málaga | Spain |
|
| H. Morales Meseguer | Not yet recruiting | Murcia | Spain |
|
| H. Virgen de la Arrixaca | Not yet recruiting | Murcia | Spain |
|
| H. Virgen de la Arrixaca | Not yet recruiting | Murcia | Spain |
|
| H. Virgen de la Arrixaca | Not yet recruiting | Murcia | Spain |
|
| Complejo Hosp. Univ. de Orense | Not yet recruiting | Ourense | Spain |
|
| Complejo Hosp. Univ. de Orense | Not yet recruiting | Ourense | Spain |
|
| Complejo Hosp. Univ. de Orense | Not yet recruiting | Ourense | Spain |
|
| Complejo Hosp. Univ. de Orense | Not yet recruiting | Ourense | Spain |
|
| H. Central de Asturias | Recruiting | Oviedo | Spain |
|
| H Río Carrión | Not yet recruiting | Palencia | Spain |
|
| H. Son Espases | Recruiting | Palma de Mallorca | Spain |
|
| H. Son Llàtzer | Not yet recruiting | Palma de Mallorca | Spain |
|
| Complejo Hospitalario Navarra | Recruiting | Pamplona | Spain |
|
| H. Clínico Univ. de Navarra | Not yet recruiting | Pamplona | Spain |
|
| H. Virgen del Camino | Not yet recruiting | Pamplona | Spain |
|
| Complejo Hospitalario Pontevedra - Hospital Montecelo | Not yet recruiting | Pontevedra | Spain |
|
| H. Parc Taulí | Not yet recruiting | Sabadell | Spain |
|
| H. Clínico Univ. de Salamanca | Not yet recruiting | Salamanca | Spain |
|
| H. Clínico Univ. de Salamanca | Not yet recruiting | Salamanca | Spain |
|
| H Donostia | Not yet recruiting | San Sebastián | Spain |
|
| H Donostia | Not yet recruiting | San Sebastián | Spain |
|
| H Donostia | Not yet recruiting | San Sebastián | Spain |
|
| H Donostia | Not yet recruiting | San Sebastián | Spain |
|
| H. Univ. de Canarias | Not yet recruiting | Santa Cruz de Tenerife | Spain |
|
| H. Marqués de Valdecilla | Not yet recruiting | Santander | Spain |
|
| H. Marqués de Valdecilla | Not yet recruiting | Santander | Spain |
|
| Complejo Hosp. Univ. Santiago de Compostela | Not yet recruiting | Santiago de Compostela | Spain |
|
| Complejo Hosp. Univ. Santiago de Compostela | Recruiting | Santiago de Compostela | Spain |
|
| H. General de Segovia | Not yet recruiting | Segovia | Spain |
|
| H. Universitario de Valme | Not yet recruiting | Seville | Spain |
|
| H. Virgen del Rocío | Recruiting | Seville | Spain |
|
| ICO-Joan XXIII | Not yet recruiting | Tarragona | Spain |
|
| Mútua de Terrassa | Not yet recruiting | Terrassa | Spain |
|
| H Torrejón | Not yet recruiting | Torrejón de Ardoz | Spain |
|
| H. Verge de la Cinta | Not yet recruiting | Tortosa | Spain |
|
| H. Arnau de Vilanova | Not yet recruiting | Valencia | Spain |
|
| H. Clínico Univ. de Valencia | Not yet recruiting | Valencia | Spain |
|
| H. Dr. Peset | Not yet recruiting | Valencia | Spain |
|
| H. Dr. Peset | Not yet recruiting | Valencia | Spain |
|
| H. General Univ. de Valencia | Not yet recruiting | Valencia | Spain |
|
| H. la Fe | Recruiting | Valencia | Spain |
|
| H. Clínico Universitario de Valladolid | Not yet recruiting | Valladolid | Spain |
|
| H. Río Hortega | Not yet recruiting | Valladolid | Spain |
|
| H. Xeral-Cíes Vigo | Not yet recruiting | Vigo | Spain |
|
| H. Xeral-Cíes Vigo | Not yet recruiting | Vigo | Spain |
|
| H. Virgen de la Concha | Not yet recruiting | Zamora | Spain |
|
| H. Lozano Blesa | Not yet recruiting | Zaragoza | Spain |
|
| H. Miguel Servet | Not yet recruiting | Zaragoza | Spain |
|
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided