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

February 17, 2022 updated by: PETHEMA Foundation

Treatment of BCR-ABL Negative ALL in Adults According to MRD and Genetics

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Albacete, Spain
        • Not yet recruiting
        • H Albacete
        • Contact:
          • José Santiago Bermón
      • Alicante, Spain
        • Recruiting
        • H. General Univ. de Alicante
        • Contact:
          • Cristina Gil
      • Alicante, Spain
        • Not yet recruiting
        • H. General Univ. de Alicante
        • Contact:
          • Pascual Fernández Abellán
      • Barcelona, Spain
        • Recruiting
        • H. Vall d'Hebron
        • Contact:
          • Pere Barba
      • Barcelona, Spain
        • Not yet recruiting
        • Clínica Teknon
        • Contact:
          • Pilar Vivancos
      • Barcelona, Spain
        • Not yet recruiting
        • H Del Mar
        • Contact:
          • Eva Gimeno
      • Barcelona, Spain
        • Recruiting
        • H. Clinic de Barcelona
        • Contact:
          • Jordi Esteve
      • Barcelona, Spain
        • Not yet recruiting
        • H. del Mar
        • Contact:
          • Eugènia Abella Monreal
      • Barcelona, Spain
        • Recruiting
        • H. Sant Pau
        • Contact:
          • Irene Garcia-Cadenas
      • Barcelona, Spain
        • Not yet recruiting
        • H. Vall d'Hebron
        • Contact:
          • Pau Abrisqueta
      • Bellvitge, Spain
        • Not yet recruiting
        • ICO-Duran i Reynals
        • Contact:
          • Santiago Mercadal
      • Bilbao, Spain
        • Not yet recruiting
        • H Basurto
        • Contact:
          • Olga Arce Fernández
      • Bilbao, Spain
        • Recruiting
        • Hu Basurto
        • Contact:
          • Cristina Barrenetxea
      • Cadiz, Spain
        • Not yet recruiting
        • H. Jerez
        • Contact:
          • Carmen Muñoz García
      • Cadiz, Spain
        • Not yet recruiting
        • H. Puerta del Mar
        • Contact:
          • Victoria Martín Reina
      • Castelló, Spain
        • Not yet recruiting
        • H. General de Castellón
        • Contact:
          • Raimundo García Boyero
      • Cáceres, Spain
        • Not yet recruiting
        • H. San Pedro de Alcántara
        • Contact:
          • Juan Bergua
      • Córdoba, Spain
        • Not yet recruiting
        • H. Reina Sofia
        • Contact:
          • Josefina Serrano López
      • Fuenlabrada, Spain
        • Not yet recruiting
        • H. Fuenlabrada
        • Contact:
          • Pilar Bravo
      • Galdakao, Spain
        • Not yet recruiting
        • H Galdakao
        • Contact:
          • Matxalen Olivares
      • Getafe, Spain
        • Not yet recruiting
        • H. Univ. de Getafe
        • Contact:
          • Carmen Monteserín
      • Girona, Spain
        • Recruiting
        • ICO-Dr.Josep Trueta
        • Contact:
          • Nazly Santos
      • Guadalajara, Spain
        • Not yet recruiting
        • H. Guadalajara
        • Contact:
          • Miguel Díaz Morfa
      • Huelva, Spain
        • Not yet recruiting
        • H Juan Ramón Jiménez
        • Contact:
          • Encarni Gil Espárraga
      • Jaén, Spain
        • Recruiting
        • Complejo Hospitalario Ciudad De Jaen
        • Contact:
          • Angela Baena
      • Jerez De La Frontera, Spain
        • Recruiting
        • H. Jerez de la Frontera
        • Contact:
          • Lourdes Hermosín
      • La Coruña, Spain
        • Not yet recruiting
        • H. A Coruña
        • Contact:
          • Víctor Noriega Concepción
      • Lanzarote, Spain
        • Not yet recruiting
        • H. General Lanzarote
        • Contact:
          • Azueg Hong
      • Las Palmas De Gran Canaria, Spain
        • Recruiting
        • H Dr. Negrín
        • Contact:
          • Carlos Rodríguez
      • Las Palmas De Gran Canaria, Spain
        • Not yet recruiting
        • Hospital Insular de Gran Canaria
        • Contact:
          • Rosa Fernandez
      • Las Palmas De Gran Canaria, Spain
        • Not yet recruiting
        • Hu Gran Canarias Dr Negrin
        • Contact:
          • Carlos Rodríguez Medina
      • Lleida, Spain
        • Recruiting
        • H. Arnau de Vilanova
        • Contact:
          • Antoni García Guiñón
      • Lugo, Spain
        • Not yet recruiting
        • H. Lucus Augusti
        • Contact:
          • Jesús Arias Sampedro
      • Madrid, Spain
        • Not yet recruiting
        • H. Gregorio Maranon
        • Contact:
          • Mariana Bastos Oreiro
      • Madrid, Spain
        • Not yet recruiting
        • Fundacion jimenez diaz
        • Contact:
          • José Luis López Lorenzo
      • Madrid, Spain
        • Not yet recruiting
        • H La Zarzuela
        • Contact:
          • Daniel García Belmonte
      • Madrid, Spain
        • Recruiting
        • H Puerta de Hierro
        • Contact:
          • Irene Romera
      • Madrid, Spain
        • Not yet recruiting
        • H Puerta de Hierro
        • Contact:
          • Rafael Forés
      • Madrid, Spain
        • Not yet recruiting
        • H. 12 de Octubre
        • Contact:
          • Mario Rodríguez Rodríguez
      • Madrid, Spain
        • Not yet recruiting
        • H. Clínico de Madrid
        • Contact:
          • Mónica Sánchez
      • Madrid, Spain
        • Not yet recruiting
        • H. Infanta Sofia
        • Contact:
          • Pilar Massó
      • Madrid, Spain
        • Recruiting
        • H. Madrid-Norte Sanchinarro
        • Contact:
          • Alfons Serrano
      • Madrid, Spain
        • Recruiting
        • H. Ramon y Cajal
        • Contact:
          • Alberto González
      • Madrid, Spain
        • Not yet recruiting
        • H. Ramon y Cajal
        • Contact:
          • Anabelle Chinea
      • Madrid, Spain
        • Not yet recruiting
        • H. Univ La Paz
        • Contact:
          • Dolores Hernández Maraver
      • Madrid, Spain
        • Not yet recruiting
        • Hu Infanta Leonor
        • Contact:
          • María José Penalva Moreno
      • Madrid, Spain
        • Not yet recruiting
        • Hu La Princesa
        • Contact:
          • Reyes Arranz
      • Murcia, Spain
        • Not yet recruiting
        • H. Morales Meseguer
        • Contact:
          • Maria Luz Amigo Lozano
      • Murcia, Spain
        • Not yet recruiting
        • H. Virgen de la Arrixaca
        • Contact:
          • Maria Carmen Garcia Garay
      • Málaga, Spain
        • Not yet recruiting
        • H. Carlos Haya
        • Contact:
          • Concha Bethencourt
      • Málaga, Spain
        • Recruiting
        • H. Clínico Univ. Virgen de la Victoria
        • Contact:
          • MªPaz Queipo de Llano
      • Málaga, Spain
        • Recruiting
        • H. Regional de Málaga
        • Contact:
          • Alejandro Contento
      • Orense, Spain
        • Not yet recruiting
        • Complejo Hosp. Univ. de Orense
        • Contact:
          • José Angel Méndez Sánchez
      • Oviedo, Spain
        • Recruiting
        • H. Central de Asturias
        • Contact:
          • Teresa Bernal
      • Palencia, Spain
        • Not yet recruiting
        • H Río Carrión
        • Contact:
          • José María Alonso Alonso
      • Palma De Mallorca, Spain
        • Recruiting
        • H. Son Espases
        • Contact:
          • Andrés Novo
      • Palma De Mallorca, Spain
        • Not yet recruiting
        • H. Son Llàtzer
        • Contact:
          • Antònia Cladera
      • Pamplona, Spain
        • Recruiting
        • Complejo Hospitalario Navarra
        • Contact:
          • M Carmen Mateos
      • Pamplona, Spain
        • Not yet recruiting
        • H. Clínico Univ. de Navarra
        • Contact:
          • José Rifón
      • Pamplona, Spain
        • Not yet recruiting
        • H. Virgen del Camino
        • Contact:
          • Maria Carmen Mateos Rodríguez
      • Pontevedra, Spain
        • Not yet recruiting
        • Complejo Hospitalario Pontevedra - Hospital Montecelo
        • Contact:
          • Maria Lourdes Amador
      • Sabadell, Spain
        • Not yet recruiting
        • H. Parc Tauli
        • Contact:
          • Sonia Piernas
      • Salamanca, Spain
        • Not yet recruiting
        • H. Clínico Univ. de Salamanca
        • Contact:
          • Jesús Mª Hernández Rivas
      • San Sebastián, Spain
        • Not yet recruiting
        • H Donostia
        • Contact:
          • Maialen Sirvent Auzmendi
      • Santa Cruz De Tenerife, Spain
        • Not yet recruiting
        • H. Univ. de Canarias
        • Contact:
          • Beatriz Soria Santa Bárbara
      • Santander, Spain
        • Not yet recruiting
        • H. Marques De Valdecilla
        • Contact:
          • Arancha Bermúdez
      • Santiago De Compostela, Spain
        • Not yet recruiting
        • Complejo Hosp. Univ. Santiago de Compostela
        • Contact:
          • Maria José Rabuñal Martínez
      • Santiago De Compostela, Spain
        • Recruiting
        • Complejo Hosp. Univ. Santiago de Compostela
        • Contact:
          • Natalia Alonso
      • Segovia, Spain
        • Not yet recruiting
        • H. General de Segovia
        • Contact:
          • José Antonio Queizán Hernández
      • Sevilla, Spain
        • Not yet recruiting
        • H. Universitario de Valme
        • Contact:
          • Carmen Couto
      • Sevilla, Spain
        • Recruiting
        • H. Virgen del Rocio
        • Contact:
          • José González Campos
      • Tarragona, Spain
        • Not yet recruiting
        • ICO-Joan XXIII
        • Contact:
          • Marta Cervera
      • Terrassa, Spain
        • Not yet recruiting
        • Mutua de Terrassa
        • Contact:
          • Ferran Vall-Llovera Calmet
      • Torrejón De Ardoz, Spain
        • Not yet recruiting
        • H Torrejón
        • Contact:
          • Ana Sebrango Sadia
      • Tortosa, Spain
        • Not yet recruiting
        • H. Verge de la Cinta
        • Contact:
          • Xavier Ortin Font
      • Valencia, Spain
        • Not yet recruiting
        • H. Arnau de Vilanova
        • Contact:
          • Aurelio López
      • Valencia, Spain
        • Not yet recruiting
        • H. Clínico Univ. de Valencia
        • Contact:
          • Mar Tormo
      • Valencia, Spain
        • Not yet recruiting
        • H. Dr. Peset
        • Contact:
          • María Pedreño
      • Valencia, Spain
        • Not yet recruiting
        • H. General Univ. de Valencia
        • Contact:
          • Magdalena Sánchez
      • Valencia, Spain
        • Recruiting
        • H. la Fé
        • Contact:
          • Pau Montesinos
      • Valladolid, Spain
        • Not yet recruiting
        • H. Clínico Universitario de Valladolid
      • Valladolid, Spain
        • Not yet recruiting
        • H. Rio Hortega
        • Contact:
          • Alberto Cantalapiedra
      • Vigo, Spain
        • Not yet recruiting
        • H. Xeral-Cíes Vigo
        • Contact:
          • Esmeralda Benítez
      • Zamora, Spain
        • Not yet recruiting
        • H. Virgen de la Concha
        • Contact:
          • Magdalena Sierra Pacho
      • Zaragoza, Spain
        • Not yet recruiting
        • H. Lozano Blesa
        • Contact:
          • Mayte Olave
      • Zaragoza, Spain
        • Not yet recruiting
        • H. Miguel Servet
        • Contact:
          • Beatriz de Rueda
      • Ávila, Spain
        • Recruiting
        • Hospital Nuestra Señora de Sonsoles
        • Contact:
          • Miguel Cabezudo
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Ico-Hugtip
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CHEMOTHERAPY
Pediatric-type of chemotherapy
Drug: Pediatric-type of chemotherapy
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)
Other: allogeneic HSCT
Procedure: allogeneic HSCT
allogeneic HSCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
Time from diagnosis to death or last follow-up
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission (CR) rate
Time Frame: 4 or 8 weeks after treatment onset
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
Time Frame: After induction (4-8 weeks) and consolidation (16-20 weeks)
Proportion of patients who achieve and maintain the negative MRD status (<10-4)
After induction (4-8 weeks) and consolidation (16-20 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
alloSCT realization
Time Frame: Early alloHSCT: 15-20 weeks from diagnosis. Delayed: 30-35 weeks from diagnosis.
Proportion of patients who receive early or delayed alloHSCT
Early alloHSCT: 15-20 weeks from diagnosis. Delayed: 30-35 weeks from diagnosis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2019

Primary Completion (Anticipated)

November 1, 2026

Study Completion (Anticipated)

February 1, 2027

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 27, 2019

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PETHEMA LAL-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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