Treatment for adults with a specific type of leukemia
Treatment of BCR-ABL Negative ALL in Adults According to MRD and Genetics
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | PETHEMA Foundation Academic / other |
| Drugs / interventions | chemotherapy, fludarabine, prednisone |
| Locations | 108 sites (Badalona, Barcelona and 107 other locations) |
| Trial ID | NCT04179929 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with newly diagnosed Ph-negative ALL and an ECOG performance status of 0-2.
Not a fit: Patients with other types of leukemia, severe comorbidities, or those unable to provide informed consent may not benefit from this study.
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 performed: Previous studies have shown promise in treating Ph-negative ALL with similar chemotherapy regimens, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Badalona, Barcelona and 107 other locations
- Ico-Hugtip — Badalona, Barcelona, 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 (Recruiting)
- H. General Univ. de Alicante — Alicante, Spain (Not_yet_recruiting)
- Hospital Nuestra Señora de Sonsoles — Ávila, Spain (Recruiting)
- Clínica Teknon — Barcelona, Spain (Not_yet_recruiting)
- H del Mar — Barcelona, Spain (Not_yet_recruiting)
- H. Clínic de Barcelona — Barcelona, Spain (Recruiting)
- H. del Mar — Barcelona, Spain (Not_yet_recruiting)
- H. Sant Pau — Barcelona, Spain (Recruiting)
- H. Vall d'Hebron — Barcelona, Spain (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)
- Hu Basurto — Bilbao, Spain (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)
- ICO-Dr.Josep Trueta — Girona, Spain (Recruiting)
- H. Guadalajara — Guadalajara, Spain (Not_yet_recruiting)
- H Juan Ramón Jiménez — Huelva, Spain (Not_yet_recruiting)
- Complejo Hospitalario Ciudad de Jaén — Jaén, Spain (Recruiting)
- H. Jerez de la Frontera — Jerez de la Frontera, Spain (Recruiting)
- H. General Lanzarote — Lanzarote, Spain (Not_yet_recruiting)
- H Dr. Negrín — Las Palmas de Gran Canaria, Spain (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. Arnau De Vilanova — Lleida, Spain (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)
- H Puerta de Hierro — Madrid, Spain (Recruiting)
- H Puerta de Hierro — Madrid, Spain (Not_yet_recruiting)
- H. 12 de Octubre — Madrid, Spain (Not_yet_recruiting)
- H. 12 de Octubre — Madrid, Spain (Not_yet_recruiting)
- H. 12 de Octubre — Madrid, Spain (Not_yet_recruiting)
- H. 12 de Octubre — Madrid, Spain (Not_yet_recruiting)
- H. 12 de Octubre — Madrid, Spain (Not_yet_recruiting)
- H. Clínico de Madrid — Madrid, Spain (Not_yet_recruiting)
- H. Clínico de Madrid — Madrid, Spain (Not_yet_recruiting)
- H. Gregorio Marañón — Madrid, Spain (Not_yet_recruiting)
- H. Gregorio Marañón — 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.