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

NCT04179929 · tracked via the Priya Life Science Spain tracker

Sponsor

PETHEMA Foundation

Phase

Not applicable

Started

2019-11-25

Last updated

2022-02-18

Condition(s) studied

Acute Lymphoblastic Leukemia

Investigational drug(s) / intervention(s)

Pediatric-type of chemotherapyallogeneic HSCT

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)

allogeneic HSCT: allogeneic HSCT

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

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

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.

Primary outcome measure(s)

Overall survival — 3 years
Time from diagnosis to death or last follow-up

Trial sites (108)

Facility	City	Region	Status
Ico-Hugtip	Badalona	Barcelona	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

+ 68 more sites — see the full list on the official registry below.

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Other trials for the same condition

Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia Recruiting

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Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL Active, not recruiting

Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04179929 on ClinicalTrials.gov ↗ ← All trials in Spain