Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults

Last updated: February 17, 2022
Sponsor: PETHEMA Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoproliferative Disorders

Leukemia

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT04179929
PETHEMA LAL-2019
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • Mature B-ALL, Ph+ ALL or blast crisis of chronic myeloid leukemia (CML), ALL ofambiguous 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

Total Participants: 300
Study Start date:
November 25, 2019
Estimated Completion Date:
February 28, 2027

Study 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.

Connect with a study center

  • Ico-Hugtip

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • H Albacete

    Albacete,
    Spain

    Site Not Available

  • H. General Univ. de Alicante

    Alicante,
    Spain

    Site Not Available

  • Clínica Teknon

    Barcelona,
    Spain

    Site Not Available

  • H del Mar

    Barcelona,
    Spain

    Site Not Available

  • H. Clínic de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • H. Sant Pau

    Barcelona,
    Spain

    Active - Recruiting

  • H. Vall d'Hebron

    Barcelona,
    Spain

    Site Not Available

  • H. del Mar

    Barcelona,
    Spain

    Site Not Available

  • ICO-Duran i Reynals

    Bellvitge,
    Spain

    Site Not Available

  • H Basurto

    Bilbao,
    Spain

    Site Not Available

  • Hu Basurto

    Bilbao,
    Spain

    Active - Recruiting

  • H. Jerez

    Cadiz,
    Spain

    Site Not Available

  • H. Puerta del Mar

    Cadiz,
    Spain

    Site Not Available

  • H. General de Castellón

    Castelló,
    Spain

    Site Not Available

  • H. San Pedro de Alcántara

    Cáceres,
    Spain

    Site Not Available

  • H. Reina Sofía

    Córdoba,
    Spain

    Site Not Available

  • H. Fuenlabrada

    Fuenlabrada,
    Spain

    Site Not Available

  • H Galdakao

    Galdakao,
    Spain

    Site Not Available

  • H. Univ. De Getafe

    Getafe,
    Spain

    Site Not Available

  • ICO-Dr.Josep Trueta

    Girona,
    Spain

    Active - Recruiting

  • H. Guadalajara

    Guadalajara,
    Spain

    Site Not Available

  • H Juan Ramón Jiménez

    Huelva,
    Spain

    Site Not Available

  • Complejo Hospitalario Ciudad de Jaén

    Jaén,
    Spain

    Active - Recruiting

  • H. Jerez de la Frontera

    Jerez De La Frontera,
    Spain

    Active - Recruiting

  • H. A Coruña

    La Coruña,
    Spain

    Site Not Available

  • H. General Lanzarote

    Lanzarote,
    Spain

    Site Not Available

  • H Dr. Negrín

    Las Palmas De Gran Canaria,
    Spain

    Active - Recruiting

  • Hospital Insular de Gran Canaria

    Las Palmas De Gran Canaria,
    Spain

    Site Not Available

  • Hu Gran Canarias Dr Negrin

    Las Palmas De Gran Canaria,
    Spain

    Site Not Available

  • H. Arnau De Vilanova

    Lleida,
    Spain

    Active - Recruiting

  • H. Lucus Augusti

    Lugo,
    Spain

    Site Not Available

  • Fundación Jiménez Díaz

    Madrid,
    Spain

    Site Not Available

  • H La Zarzuela

    Madrid,
    Spain

    Site Not Available

  • H Puerta de Hierro

    Madrid,
    Spain

    Site Not Available

  • H. 12 de Octubre

    Madrid,
    Spain

    Site Not Available

  • H. Clínico de Madrid

    Madrid,
    Spain

    Site Not Available

  • H. Gregorio Marañón

    Madrid,
    Spain

    Site Not Available

  • H. Infanta Sofía

    Madrid,
    Spain

    Site Not Available

  • H. Madrid-Norte Sanchinarro

    Madrid,
    Spain

    Active - Recruiting

  • H. Ramón y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • H. Univ La Paz

    Madrid,
    Spain

    Site Not Available

  • Hu Infanta Leonor

    Madrid,
    Spain

    Site Not Available

  • Hu La Princesa

    Madrid,
    Spain

    Site Not Available

  • H. Morales Meseguer

    Murcia,
    Spain

    Site Not Available

  • H. Virgen de la Arrixaca

    Murcia,
    Spain

    Site Not Available

  • H. Carlos Haya

    Málaga,
    Spain

    Site Not Available

  • H. Clínico Univ. Virgen de la Victoria

    Málaga,
    Spain

    Active - Recruiting

  • H. Regional de Málaga

    Málaga,
    Spain

    Active - Recruiting

  • Complejo Hosp. Univ. de Orense

    Orense,
    Spain

    Site Not Available

  • H. Central de Asturias

    Oviedo,
    Spain

    Active - Recruiting

  • H Río Carrión

    Palencia,
    Spain

    Site Not Available

  • H. Son Espases

    Palma De Mallorca,
    Spain

    Active - Recruiting

  • H. Son Llàtzer

    Palma De Mallorca,
    Spain

    Site Not Available

  • Complejo Hospitalario Navarra

    Pamplona,
    Spain

    Active - Recruiting

  • H. Clínico Univ. de Navarra

    Pamplona,
    Spain

    Site Not Available

  • H. Virgen del Camino

    Pamplona,
    Spain

    Site Not Available

  • Complejo Hospitalario Pontevedra - Hospital Montecelo

    Pontevedra,
    Spain

    Site Not Available

  • H. Parc Taulí

    Sabadell,
    Spain

    Site Not Available

  • H. Clínico Univ. de Salamanca

    Salamanca,
    Spain

    Site Not Available

  • H Donostia

    San Sebastián,
    Spain

    Site Not Available

  • H. Univ. de Canarias

    Santa Cruz De Tenerife,
    Spain

    Site Not Available

  • H. Marqués de Valdecilla

    Santander,
    Spain

    Site Not Available

  • Complejo Hosp. Univ. Santiago de Compostela

    Santiago De Compostela,
    Spain

    Site Not Available

  • H. General de Segovia

    Segovia,
    Spain

    Site Not Available

  • H. Universitario de Valme

    Sevilla,
    Spain

    Site Not Available

  • H. Virgen del Rocío

    Sevilla,
    Spain

    Active - Recruiting

  • ICO-Joan XXIII

    Tarragona,
    Spain

    Site Not Available

  • Mútua de Terrassa

    Terrassa,
    Spain

    Site Not Available

  • H Torrejón

    Torrejón De Ardoz,
    Spain

    Site Not Available

  • H. Verge de la Cinta

    Tortosa,
    Spain

    Site Not Available

  • H. Arnau de Vilanova

    Valencia,
    Spain

    Site Not Available

  • H. Clínico Univ. de Valencia

    Valencia,
    Spain

    Site Not Available

  • H. Dr. Peset

    Valencia,
    Spain

    Site Not Available

  • H. General Univ. de Valencia

    Valencia,
    Spain

    Site Not Available

  • H. la Fe

    Valencia,
    Spain

    Active - Recruiting

  • H. Clínico Universitario de Valladolid

    Valladolid,
    Spain

    Site Not Available

  • H. Río Hortega

    Valladolid,
    Spain

    Site Not Available

  • H. Xeral-Cíes Vigo

    Vigo,
    Spain

    Site Not Available

  • H. Virgen de la Concha

    Zamora,
    Spain

    Site Not Available

  • H. Lozano Blesa

    Zaragoza,
    Spain

    Site Not Available

  • H. Miguel Servet

    Zaragoza,
    Spain

    Site Not Available

  • Hospital Nuestra Señora de Sonsoles

    Ávila,
    Spain

    Active - Recruiting

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