Clinical trial Recruiting at 23 sites Interventional Ages 18 to 60

Treatment for adults with a specific type of leukemia

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

Run by PETHEMA Foundation · NCT04179929 · Data updated 2026-11-12

This study is testing a new treatment plan for adults with a specific type of leukemia to see if it helps them stay healthy after their initial therapy.

Quick facts

Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment300 (estimated)
SponsorPETHEMA Foundation
Academic / other
Drugs / interventionschemotherapy, fludarabine, prednisone
Locations108 sites (Badalona, Barcelona and 107 other locations)
StatusRecruiting
StartedNovember 25, 2019
Main results expectedNovember 2026
Study endsFebruary 2027
Registry record updatedFebruary 18, 2022
Trial IDNCT04179929 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-60 with newly diagnosed Ph-negative ALL and an ECOG performance status of 0-2.

Probably not a fit

Patients with other types of leukemia, severe comorbidities, or those unable to provide informed consent may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on treating adult patients aged 18-60 with Ph-negative Acute Lymphoblastic Leukemia (ALL) after initial consolidation therapy. Participants will receive a standardized four-drug induction chemotherapy regimen, followed by additional treatments based on measurable residual disease (MRD) clearance and genetic testing results. Those with adequate MRD clearance may undergo further consolidation and maintenance therapy, while others may be considered for allogeneic hematopoietic stem cell transplantation. The study aims to optimize treatment strategies for this challenging condition.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for adults with Ph-negative ALL.

How similar studies have gone: Previous studies have shown promise in treating Ph-negative ALL with similar chemotherapy regimens, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Ico-Hugtip
    Badalona, Barcelona, Spain
    Recruiting
  • H. General Univ. de Alicante
    Alicante, Spain
    Recruiting
  • Hospital Nuestra Señora de Sonsoles
    Ávila, Spain
    Recruiting
  • H. Clínic de Barcelona
    Barcelona, Spain
    Recruiting
  • H. Sant Pau
    Barcelona, Spain
    Recruiting
  • H. Vall d'Hebron
    Barcelona, Spain
    Recruiting
Show 44 more locations
  • Hu Basurto
    Bilbao, Spain
    Recruiting
  • ICO-Dr.Josep Trueta
    Girona, Spain
    Recruiting
  • Complejo Hospitalario Ciudad de Jaén
    Jaén, Spain
    Recruiting
  • H. Jerez de la Frontera
    Jerez de la Frontera, Spain
    Recruiting
  • H Dr. Negrín
    Las Palmas de Gran Canaria, Spain
    Recruiting
  • H. Arnau De Vilanova
    Lleida, Spain
    Recruiting
  • H Puerta de Hierro
    Madrid, Spain
    Recruiting
  • H. Madrid-Norte Sanchinarro
    Madrid, Spain
    Recruiting
  • H. Ramón y Cajal
    Madrid, Spain
    Recruiting
  • H. Clínico Univ. Virgen de la Victoria
    Málaga, Spain
    Recruiting
  • H. Regional de Málaga
    Málaga, Spain
    Recruiting
  • H. Central de Asturias
    Oviedo, Spain
    Recruiting
  • H. Son Espases
    Palma de Mallorca, Spain
    Recruiting
  • Complejo Hospitalario Navarra
    Pamplona, Spain
    Recruiting
  • Complejo Hosp. Univ. Santiago de Compostela
    Santiago de Compostela, Spain
    Recruiting
  • H. Virgen del Rocío
    Seville, Spain
    Recruiting
  • H. la Fe
    Valencia, Spain
    Recruiting
  • H. A Coruña
    A Coruña, Spain
    Not yet recruiting
  • H Albacete
    Albacete, Spain
    Not yet recruiting
  • H. General Univ. de Alicante
    Alicante, Spain
    Not yet recruiting
  • Clínica Teknon
    Barcelona, Spain
    Not yet recruiting
  • H del Mar
    Barcelona, Spain
    Not yet recruiting
  • H. del Mar
    Barcelona, Spain
    Not yet recruiting
  • H. Vall d'Hebron
    Barcelona, Spain
    Not yet recruiting
  • ICO-Duran i Reynals
    Bellvitge, Spain
    Not yet recruiting
  • H Basurto
    Bilbao, Spain
    Not yet recruiting
  • H. Jerez
    Cadiz, Spain
    Not yet recruiting
  • H. Puerta del Mar
    Cadiz, Spain
    Not yet recruiting
  • H. General de Castellón
    Castelló, Spain
    Not yet recruiting
  • H. San Pedro de Alcántara
    Cáceres, Spain
    Not yet recruiting
  • H. Reina Sofía
    Córdoba, Spain
    Not yet recruiting
  • H. Fuenlabrada
    Fuenlabrada, Spain
    Not yet recruiting
  • H Galdakao
    Galdakao, Spain
    Not yet recruiting
  • H. Univ. De Getafe
    Getafe, Spain
    Not yet recruiting
  • H. Guadalajara
    Guadalajara, Spain
    Not yet recruiting
  • H Juan Ramón Jiménez
    Huelva, Spain
    Not yet recruiting
  • H. General Lanzarote
    Lanzarote, Spain
    Not yet recruiting
  • Hospital Insular de Gran Canaria
    Las Palmas de Gran Canaria, Spain
    Not yet recruiting
  • Hu Gran Canarias Dr Negrin
    Las Palmas de Gran Canaria, Spain
    Not yet recruiting
  • H. Lucus Augusti
    Lugo, Spain
    Not yet recruiting
  • H. Lucus Augusti
    Lugo, Spain
    Not yet recruiting
  • H. Lucus Augusti
    Lugo, Spain
    Not yet recruiting
  • Fundación Jiménez Díaz
    Madrid, Spain
    Not yet recruiting
  • H La Zarzuela
    Madrid, Spain
    Not yet recruiting

+58 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.