Acute Lymphoblastic LeukemiaNCT04179929

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

A study testing Pediatric-type of chemotherapy and allogeneic HSCT in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 108 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Acute Lymphoblastic Leukemia
What is being tested?: Pediatric-type of chemotherapy and allogeneic HSCT
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 108 sitesSpain
Study dates: 25 Nov 2019to Feb 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

108 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Josep Maria Ribera, Ph contact

934978987

jribera@iconcologia.net

City, postcode or hospital

Sites recruiting now only

108 sites in 1 country

Spain108 sites, 108 recruiting

H. A Coruña
A Coruña
Víctor Noriega Concepción
Not yet recruiting
H Albacete
Albacete
José Santiago Bermón
Not yet recruiting
H. General Univ. de Alicante
Alicante
Cristina Gil
Recruiting
H. General Univ. de Alicante
Alicante
Pascual Fernández Abellán
Not yet recruiting
Hospital Nuestra Señora de Sonsoles
Ávila
Miguel Cabezudo
Recruiting
Ico-Hugtip
Badalona, Barcelona, 08916
Jose Maria Ribera Santasusana, 934978987, jribera@iconcologia.net
Recruiting
Clínica Teknon
Barcelona
Pilar Vivancos
Not yet recruiting
H del Mar
Barcelona
Eva Gimeno
Not yet recruiting
H. Clínic de Barcelona
Barcelona
Jordi Esteve
Recruiting
H. del Mar
Barcelona
Eugènia Abella Monreal
Not yet recruiting
H. Sant Pau
Barcelona
Irene García-Cadenas
Recruiting
H. Vall d'Hebron
Barcelona
Pere Barba
Recruiting
H. Vall d'Hebron
Barcelona
Pau Abrisqueta
Not yet recruiting
ICO-Duran i Reynals
Bellvitge
Santiago Mercadal
Not yet recruiting
H Basurto
Bilbao
Olga Arce Fernández
Not yet recruiting
Hu Basurto
Bilbao
Cristina Barrenetxea
Recruiting
H. San Pedro de Alcántara
Cáceres
Juan Bergua
Not yet recruiting
H. Jerez
Cadiz
Carmen Muñoz García
Not yet recruiting
H. Puerta del Mar
Cadiz
Victoria Martín Reina
Not yet recruiting
H. General de Castellón
Castelló
Raimundo García Boyero
Not yet recruiting
H. Reina Sofía
Córdoba
Josefina Serrano López
Not yet recruiting
H. Fuenlabrada
Fuenlabrada
Pilar Bravo
Not yet recruiting
H Galdakao
Galdakao
Matxalen Olivares
Not yet recruiting
H. Univ. De Getafe
Getafe
Carmen Monteserín
Not yet recruiting
ICO-Dr.Josep Trueta
Girona
Nazly Santos
Recruiting
H. Guadalajara
Guadalajara
Miguel Díaz Morfa
Not yet recruiting
H Juan Ramón Jiménez
Huelva
Encarni Gil Espárraga
Not yet recruiting
Complejo Hospitalario Ciudad de Jaén
Jaén
Angela Baena
Recruiting
H. Jerez de la Frontera
Jerez de la Frontera
Lourdes Hermosín
Recruiting
H. General Lanzarote
Lanzarote
Azueg Hong
Not yet recruiting
H Dr. Negrín
Las Palmas de Gran Canaria
Carlos Rodríguez
Recruiting
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria
Rosa Fernández
Not yet recruiting
Hu Gran Canarias Dr Negrin
Las Palmas de Gran Canaria
Carlos Rodríguez Medina
Not yet recruiting
H. Arnau De Vilanova
Lleida
Antoni García Guiñón
Recruiting
H. Lucus Augusti
Lugo
Esperanza Lavilla
Not yet recruiting
H. Lucus Augusti
Lugo
Maria José Sánchez Sánchez
Not yet recruiting
H. Lucus Augusti
Lugo
Jesús Arias Sampedro
Not yet recruiting
Fundación Jiménez Díaz
Madrid
José Luis López Lorenzo
Not yet recruiting
H La Zarzuela
Madrid
Daniel García Belmonte
Not yet recruiting
H Puerta de Hierro
Madrid
Irene Romera
Recruiting
H Puerta de Hierro
Madrid
Rafael Forés
Not yet recruiting
H. 12 de Octubre
Madrid
Carlos Grande
Not yet recruiting
H. 12 de Octubre
Madrid
Pilar Martínez Sánchez
Not yet recruiting
H. 12 de Octubre
Madrid
José María Sánchez Pina
Not yet recruiting
H. 12 de Octubre
Madrid
María Calbacho
Not yet recruiting
H. 12 de Octubre
Madrid
Mario Rodríguez Rodríguez
Not yet recruiting
H. Clínico de Madrid
Madrid
Eloy del Potro
Not yet recruiting
H. Clínico de Madrid
Madrid
Mónica Sánchez
Not yet recruiting
H. Gregorio Marañón
Madrid
Silvia Monsalvo
Not yet recruiting
H. Gregorio Marañón
Madrid
Mariana Bastos Oreiro
Not yet recruiting
H. Infanta Sofía
Madrid
Pilar Massó
Not yet recruiting
H. Madrid-Norte Sanchinarro
Madrid
Alfons Serrano
Recruiting
H. Ramón y Cajal
Madrid
Alberto González
Recruiting
H. Ramón y Cajal
Madrid
Anabelle Chinea
Not yet recruiting
H. Univ La Paz
Madrid
Dolores Hernández Maraver
Not yet recruiting
Hu Infanta Leonor
Madrid
María José Penalva Moreno
Not yet recruiting
Hu La Princesa
Madrid
Reyes Arranz
Not yet recruiting
H. Carlos Haya
Málaga
Concha Bethencourt
Not yet recruiting
H. Clínico Univ. Virgen de la Victoria
Málaga
MªPaz Queipo de Llano
Recruiting
H. Regional de Málaga
Málaga
Alejandro Contento
Recruiting
H. Morales Meseguer
Murcia
Maria Luz Amigo Lozano
Not yet recruiting
H. Virgen de la Arrixaca
Murcia
José Maria Moraleda
Not yet recruiting
H. Virgen de la Arrixaca
Murcia
Andrés Sánchez Salinas
Not yet recruiting
H. Virgen de la Arrixaca
Murcia
Maria Carmen Garcia Garay
Not yet recruiting
Complejo Hosp. Univ. de Orense
Ourense
María Elsa López Ansoar
Not yet recruiting
Complejo Hosp. Univ. de Orense
Ourense
Manuel Albors Ferreiro
Not yet recruiting
Complejo Hosp. Univ. de Orense
Ourense
Marta Rodríguez
Not yet recruiting
Complejo Hosp. Univ. de Orense
Ourense
José Angel Méndez Sánchez
Not yet recruiting
H. Central de Asturias
Oviedo
Teresa Bernal
Recruiting
H Río Carrión
Palencia
José María Alonso Alonso
Not yet recruiting
H. Son Espases
Palma de Mallorca
Andrés Novo
Recruiting
H. Son Llàtzer
Palma de Mallorca
Antònia Cladera
Not yet recruiting
Complejo Hospitalario Navarra
Pamplona
M Carmen Mateos
Recruiting
H. Clínico Univ. de Navarra
Pamplona
José Rifón
Not yet recruiting
H. Virgen del Camino
Pamplona
Maria Carmen Mateos Rodríguez
Not yet recruiting
Complejo Hospitalario Pontevedra - Hospital Montecelo
Pontevedra
Maria Lourdes Amador
Not yet recruiting
H. Parc Taulí
Sabadell
Sonia Piernas
Not yet recruiting
H. Clínico Univ. de Salamanca
Salamanca
Mónica Cabrero
Not yet recruiting
H. Clínico Univ. de Salamanca
Salamanca
Jesús Mª Hernández Rivas
Not yet recruiting
H Donostia
San Sebastián
Maria Teresa Artola
Not yet recruiting
H Donostia
San Sebastián
Nerea Caminos Uresandi
Not yet recruiting
H Donostia
San Sebastián
Izaskun Ceberio
Not yet recruiting
H Donostia
San Sebastián
Maialen Sirvent Auzmendi
Not yet recruiting
H. Univ. de Canarias
Santa Cruz de Tenerife
Beatriz Soria Santa Bárbara
Not yet recruiting
H. Marqués de Valdecilla
Santander
Mercedes Colorado
Not yet recruiting
H. Marqués de Valdecilla
Santander
Arancha Bermúdez
Not yet recruiting
Complejo Hosp. Univ. Santiago de Compostela
Santiago de Compostela
Maria José Rabuñal Martínez
Not yet recruiting
Complejo Hosp. Univ. Santiago de Compostela
Santiago de Compostela
Natalia Alonso
Recruiting
H. General de Segovia
Segovia
José Antonio Queizán Hernández
Not yet recruiting
H. Universitario de Valme
Seville
Carmen Couto
Not yet recruiting
H. Virgen del Rocío
Seville
José González Campos
Recruiting
ICO-Joan XXIII
Tarragona
Marta Cervera
Not yet recruiting
Mútua de Terrassa
Terrassa
Ferran Vall-Llovera Calmet
Not yet recruiting
H Torrejón
Torrejón de Ardoz
Ana Sebrango Sadia
Not yet recruiting
H. Verge de la Cinta
Tortosa
Xavier Ortin Font
Not yet recruiting
H. Arnau de Vilanova
Valencia
Aurelio López
Not yet recruiting
H. Clínico Univ. de Valencia
Valencia
Mar Tormo
Not yet recruiting
H. Dr. Peset
Valencia
María José Sayas
Not yet recruiting
H. Dr. Peset
Valencia
María Pedreño
Not yet recruiting
H. General Univ. de Valencia
Valencia
Magdalena Sánchez
Not yet recruiting
H. la Fe
Valencia
Pau Montesinos
Recruiting
H. Clínico Universitario de Valladolid
Valladolid
María Jesús Peñarrubia
Not yet recruiting
H. Río Hortega
Valladolid
Alberto Cantalapiedra
Not yet recruiting
H. Xeral-Cíes Vigo
Vigo
Ángeles Fernández Fernández
Not yet recruiting
H. Xeral-Cíes Vigo
Vigo
Esmeralda Benítez
Not yet recruiting
H. Virgen de la Concha
Zamora
Magdalena Sierra Pacho
Not yet recruiting
H. Lozano Blesa
Zaragoza
Mayte Olave
Not yet recruiting
H. Miguel Servet
Zaragoza
Beatriz de Rueda
Not yet recruiting

Other trials in Spain

About this study

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

Read the 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.

Conditions: Acute Lymphoblastic Leukemia
Being tested: Pediatric-type of chemotherapy, allogeneic HSCT
Keywords: ALL, adult, Ph-negative, minimal residual disease, transplantation
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pediatric-type of chemotherapyDrug
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 HSCTProcedure or surgery
allogeneic HSCT

Study groups in NCT04179929
Study group	Role	What they receive
CHEMOTHERAPY	Other	Pediatric-type of chemotherapy Receives: Drug: Pediatric-type of chemotherapy
allogeneic HSCT	Other	allogeneic HSCT Receives: Procedure: allogeneic HSCT

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Complete remission (CR) rate
Proportion of patients who achieve CR with or 2 induction therapy lines
Measured: 4 or 8 weeks after treatment onset
MRD status after induction and consolidation
Proportion of patients who achieve and maintain the negative MRD status (<10-4)
Measured: After induction (4-8 weeks) and consolidation (16-20 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Nov 2019Feb 2027

First posted27 Nov 2019
Study start25 Nov 2019
Primary completionNov 2026 (estimated)
Study completionFeb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04179929
Sponsor's protocol ID: PETHEMA LAL-2019
Status last verified: Feb 2022
First submitted: 20 Nov 2019
Last updated: 18 Feb 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ribera JM, Torrent A, Morgades M, Barrena S, Ribera J, Genesca E, Gonzalez-Campos J, Martinez-Cibrian N, Montesinos P, Hernandez Sanchez A, Barba P, Zapico E Sr, Sanchez R, Novo A, Sitges M, Maluquer Artigal C, Such E, Botella C, Queipo de Llano MP, Cabrero M, Vicent A, Lopez de Ugarriza P, Tormo M, Gonzalez-Gonzalez BJ, Garcia-Cadenas I, Rodriguez-Medina C, Martinez Sanchez P, Bermudez A, Gomez-Centurion I, Herrero-Garcia M, Ciudad J, Navas-Acosta J, Hermosin L, Serrano J, Raposo-Puglia JA, Solan L, Roldan-Galiacho V, de Laiglesia A, Gomez-Perez L, Sole-Rodriguez M, Casado MS Sr, Llorente Gonzalez L, Barrios Decoud D, Vall-Llovera F, Algarra JL, Amador L, Garcia-Boyero R, Cladera A, Bergua Burgues JM, Calasanz MJJ, Granada I, Feliu E, Hernandez-Rivas JM, Orfao A. Genetics and MRD for therapy allocation in adults with Philadelphia chromosome-negative acute lymphoblastic leukemia. Blood. 2026 May 4:blood.2025032645. doi: 10.1182/blood.2025032645. Online ahead of print.
PubMed 42081455