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 type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | PETHEMA Foundation Academic / other |
| Drugs / interventions | chemotherapy, fludarabine, prednisone |
| Locations | 108 sites (Badalona, Barcelona and 107 other locations) |
| Status | Recruiting |
| Started | November 25, 2019 |
| Main results expected | November 2026 |
| Study ends | February 2027 |
| Registry record updated | February 18, 2022 |
| Trial ID | NCT04179929 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
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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
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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
- Study coordinator: Josep Maria Ribera, Ph
- Email: jribera@iconcologia.net
- Phone: 934978987
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.