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

NCT ID: NCT04179929

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-25

Study Completion Date

2027-02-28

Brief Summary

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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.

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PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

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Detailed Description

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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

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CHEMOTHERAPY

Pediatric-type of chemotherapy

Group Type OTHER

Pediatric-type of chemotherapy

Intervention Type DRUG

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

Group Type OTHER

allogeneic HSCT

Intervention Type PROCEDURE

allogeneic HSCT

Interventions

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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)

Intervention Type DRUG

allogeneic HSCT

allogeneic HSCT

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PETHEMA Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ico-Hugtip

Badalona, Barcelona, Spain

Site Status RECRUITING

H. A Coruña

A Coruña, , Spain

Site Status NOT_YET_RECRUITING

H Albacete

Albacete, , Spain

Site Status NOT_YET_RECRUITING

H. General Univ. de Alicante

Alicante, , Spain

Site Status RECRUITING

H. General Univ. de Alicante

Alicante, , Spain

Site Status NOT_YET_RECRUITING

Hospital Nuestra Señora de Sonsoles

Ávila, , Spain

Site Status RECRUITING

Clínica Teknon

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

H del Mar

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

H. Clínic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

H. del Mar

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

H. Sant Pau

Barcelona, , Spain

Site Status RECRUITING

H. Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

H. Vall d'Hebron

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

ICO-Duran i Reynals

Bellvitge, , Spain

Site Status NOT_YET_RECRUITING

H Basurto

Bilbao, , Spain

Site Status NOT_YET_RECRUITING

Hu Basurto

Bilbao, , Spain

Site Status RECRUITING

H. Jerez

Cadiz, , Spain

Site Status NOT_YET_RECRUITING

H. Puerta del Mar

Cadiz, , Spain

Site Status NOT_YET_RECRUITING

H. General de Castellón

Castelló, , Spain

Site Status NOT_YET_RECRUITING

H. San Pedro de Alcántara

Cáceres, , Spain

Site Status NOT_YET_RECRUITING

H. Reina Sofía

Córdoba, , Spain

Site Status NOT_YET_RECRUITING

H. Fuenlabrada

Fuenlabrada, , Spain

Site Status NOT_YET_RECRUITING

H Galdakao

Galdakao, , Spain

Site Status NOT_YET_RECRUITING

H. Univ. De Getafe

Getafe, , Spain

Site Status NOT_YET_RECRUITING

ICO-Dr.Josep Trueta

Girona, , Spain

Site Status RECRUITING

H. Guadalajara

Guadalajara, , Spain

Site Status NOT_YET_RECRUITING

H Juan Ramón Jiménez

Huelva, , Spain

Site Status NOT_YET_RECRUITING

Complejo Hospitalario Ciudad de Jaén

Jaén, , Spain

Site Status RECRUITING

H. Jerez de la Frontera

Jerez de la Frontera, , Spain

Site Status RECRUITING

H. General Lanzarote

Lanzarote, , Spain

Site Status NOT_YET_RECRUITING

H Dr. Negrín

Las Palmas de Gran Canaria, , Spain

Site Status RECRUITING

Hospital Insular de Gran Canaria

Las Palmas de Gran Canaria, , Spain

Site Status NOT_YET_RECRUITING

Hu Gran Canarias Dr Negrin

Las Palmas de Gran Canaria, , Spain

Site Status NOT_YET_RECRUITING

H. Arnau De Vilanova

Lleida, , Spain

Site Status RECRUITING

H. Lucus Augusti

Lugo, , Spain

Site Status NOT_YET_RECRUITING

H. Lucus Augusti

Lugo, , Spain

Site Status NOT_YET_RECRUITING

H. Lucus Augusti

Lugo, , Spain

Site Status NOT_YET_RECRUITING

Fundación Jiménez Díaz

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H La Zarzuela

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H Puerta de Hierro

Madrid, , Spain

Site Status RECRUITING

H Puerta de Hierro

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H. 12 de Octubre

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H. 12 de Octubre

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H. 12 de Octubre

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H. 12 de Octubre

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H. 12 de Octubre

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H. Clínico de Madrid

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H. Clínico de Madrid

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H. Gregorio Marañón

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H. Gregorio Marañón

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H. Infanta Sofía

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H. Madrid-Norte Sanchinarro

Madrid, , Spain

Site Status RECRUITING

H. Ramón y Cajal

Madrid, , Spain

Site Status RECRUITING

H. Ramón y Cajal

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H. Univ La Paz

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hu Infanta Leonor

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hu La Princesa

Madrid, , Spain

Site Status NOT_YET_RECRUITING

H. Carlos Haya

Málaga, , Spain

Site Status NOT_YET_RECRUITING

H. Clínico Univ. Virgen de la Victoria

Málaga, , Spain

Site Status RECRUITING

H. Regional de Málaga

Málaga, , Spain

Site Status RECRUITING

H. Morales Meseguer

Murcia, , Spain

Site Status NOT_YET_RECRUITING

H. Virgen de la Arrixaca

Murcia, , Spain

Site Status NOT_YET_RECRUITING

H. Virgen de la Arrixaca

Murcia, , Spain

Site Status NOT_YET_RECRUITING

H. Virgen de la Arrixaca

Murcia, , Spain

Site Status NOT_YET_RECRUITING

Complejo Hosp. Univ. de Orense

Ourense, , Spain

Site Status NOT_YET_RECRUITING

Complejo Hosp. Univ. de Orense

Ourense, , Spain

Site Status NOT_YET_RECRUITING

Complejo Hosp. Univ. de Orense

Ourense, , Spain

Site Status NOT_YET_RECRUITING

Complejo Hosp. Univ. de Orense

Ourense, , Spain

Site Status NOT_YET_RECRUITING

H. Central de Asturias

Oviedo, , Spain

Site Status RECRUITING

H Río Carrión

Palencia, , Spain

Site Status NOT_YET_RECRUITING

H. Son Espases

Palma de Mallorca, , Spain

Site Status RECRUITING

H. Son Llàtzer

Palma de Mallorca, , Spain

Site Status NOT_YET_RECRUITING

Complejo Hospitalario Navarra

Pamplona, , Spain

Site Status RECRUITING

H. Clínico Univ. de Navarra

Pamplona, , Spain

Site Status NOT_YET_RECRUITING

H. Virgen del Camino

Pamplona, , Spain

Site Status NOT_YET_RECRUITING

Complejo Hospitalario Pontevedra - Hospital Montecelo

Pontevedra, , Spain

Site Status NOT_YET_RECRUITING

H. Parc Taulí

Sabadell, , Spain

Site Status NOT_YET_RECRUITING

H. Clínico Univ. de Salamanca

Salamanca, , Spain

Site Status NOT_YET_RECRUITING

H. Clínico Univ. de Salamanca

Salamanca, , Spain

Site Status NOT_YET_RECRUITING

H Donostia

San Sebastián, , Spain

Site Status NOT_YET_RECRUITING

H Donostia

San Sebastián, , Spain

Site Status NOT_YET_RECRUITING

H Donostia

San Sebastián, , Spain

Site Status NOT_YET_RECRUITING

H Donostia

San Sebastián, , Spain

Site Status NOT_YET_RECRUITING

H. Univ. de Canarias

Santa Cruz de Tenerife, , Spain

Site Status NOT_YET_RECRUITING

H. Marqués de Valdecilla

Santander, , Spain

Site Status NOT_YET_RECRUITING

H. Marqués de Valdecilla

Santander, , Spain

Site Status NOT_YET_RECRUITING

Complejo Hosp. Univ. Santiago de Compostela

Santiago de Compostela, , Spain

Site Status NOT_YET_RECRUITING

Complejo Hosp. Univ. Santiago de Compostela

Santiago de Compostela, , Spain

Site Status RECRUITING

H. General de Segovia

Segovia, , Spain

Site Status NOT_YET_RECRUITING

H. Universitario de Valme

Seville, , Spain

Site Status NOT_YET_RECRUITING

H. Virgen del Rocío

Seville, , Spain

Site Status RECRUITING

ICO-Joan XXIII

Tarragona, , Spain

Site Status NOT_YET_RECRUITING

Mútua de Terrassa

Terrassa, , Spain

Site Status NOT_YET_RECRUITING

H Torrejón

Torrejón de Ardoz, , Spain

Site Status NOT_YET_RECRUITING

H. Verge de la Cinta

Tortosa, , Spain

Site Status NOT_YET_RECRUITING

H. Arnau de Vilanova

Valencia, , Spain

Site Status NOT_YET_RECRUITING

H. Clínico Univ. de Valencia

Valencia, , Spain

Site Status NOT_YET_RECRUITING

H. Dr. Peset

Valencia, , Spain

Site Status NOT_YET_RECRUITING

H. Dr. Peset

Valencia, , Spain

Site Status NOT_YET_RECRUITING

H. General Univ. de Valencia

Valencia, , Spain

Site Status NOT_YET_RECRUITING

H. la Fe

Valencia, , Spain

Site Status RECRUITING

H. Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status NOT_YET_RECRUITING

H. Río Hortega

Valladolid, , Spain

Site Status NOT_YET_RECRUITING

H. Xeral-Cíes Vigo

Vigo, , Spain

Site Status NOT_YET_RECRUITING

H. Xeral-Cíes Vigo

Vigo, , Spain

Site Status NOT_YET_RECRUITING

H. Virgen de la Concha

Zamora, , Spain

Site Status NOT_YET_RECRUITING

H. Lozano Blesa

Zaragoza, , Spain

Site Status NOT_YET_RECRUITING

H. Miguel Servet

Zaragoza, , Spain

Site Status NOT_YET_RECRUITING

Countries

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Spain

Central Contacts

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Josep Maria Ribera, Ph

Role: CONTACT

[email protected]
934978987

Facility Contacts

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Jose Maria Ribera Santasusana

Role: primary

[email protected]
934978987

Víctor Noriega Concepción

Role: primary

José Santiago Bermón

Role: primary

Cristina Gil

Role: primary

Pascual Fernández Abellán

Role: primary

Miguel Cabezudo

Role: primary

Pilar Vivancos

Role: primary

Eva Gimeno

Role: primary

Jordi Esteve

Role: primary

Eugènia Abella Monreal

Role: primary

Irene García-Cadenas

Role: primary

Pere Barba

Role: primary

Pau Abrisqueta

Role: primary

Santiago Mercadal

Role: primary

Olga Arce Fernández

Role: primary

Cristina Barrenetxea

Role: primary

Carmen Muñoz García

Role: primary

Victoria Martín Reina

Role: primary

Raimundo García Boyero

Role: primary

Juan Bergua

Role: primary

Josefina Serrano López

Role: primary

Pilar Bravo

Role: primary

Matxalen Olivares

Role: primary

Carmen Monteserín

Role: primary

Nazly Santos

Role: primary

Miguel Díaz Morfa

Role: primary

Encarni Gil Espárraga

Role: primary

Angela Baena

Role: primary

Lourdes Hermosín

Role: primary

Azueg Hong

Role: primary

Carlos Rodríguez

Role: primary

Rosa Fernández

Role: primary

Carlos Rodríguez Medina

Role: primary

Antoni García Guiñón

Role: primary

Esperanza Lavilla

Role: primary

Maria José Sánchez Sánchez

Role: primary

Jesús Arias Sampedro

Role: primary

José Luis López Lorenzo

Role: primary

Daniel García Belmonte

Role: primary

Irene Romera

Role: primary

Rafael Forés

Role: primary

Carlos Grande

Role: primary

Pilar Martínez Sánchez

Role: primary

José María Sánchez Pina

Role: primary

María Calbacho

Role: primary

Mario Rodríguez Rodríguez

Role: primary

Eloy del Potro

Role: primary

Mónica Sánchez

Role: primary

Silvia Monsalvo

Role: primary

Mariana Bastos Oreiro

Role: primary

Pilar Massó

Role: primary

Alfons Serrano

Role: primary

Alberto González

Role: primary

Anabelle Chinea

Role: primary

Dolores Hernández Maraver

Role: primary

María José Penalva Moreno

Role: primary

Reyes Arranz

Role: primary

Concha Bethencourt

Role: primary

MªPaz Queipo de Llano

Role: primary

Alejandro Contento

Role: primary

Maria Luz Amigo Lozano

Role: primary

José Maria Moraleda

Role: primary

Andrés Sánchez Salinas

Role: primary

Maria Carmen Garcia Garay

Role: primary

María Elsa López Ansoar

Role: primary

Manuel Albors Ferreiro

Role: primary

Marta Rodríguez

Role: primary

José Angel Méndez Sánchez

Role: primary

Teresa Bernal

Role: primary

José María Alonso Alonso

Role: primary

Andrés Novo

Role: primary

Antònia Cladera

Role: primary

M Carmen Mateos

Role: primary

José Rifón

Role: primary

Maria Carmen Mateos Rodríguez

Role: primary

Maria Lourdes Amador

Role: primary

Sonia Piernas

Role: primary

Mónica Cabrero

Role: primary

Jesús Mª Hernández Rivas

Role: primary

Maria Teresa Artola

Role: primary

Nerea Caminos Uresandi

Role: primary

Izaskun Ceberio

Role: primary

Maialen Sirvent Auzmendi

Role: primary

Beatriz Soria Santa Bárbara

Role: primary

Mercedes Colorado

Role: primary

Arancha Bermúdez

Role: primary

Maria José Rabuñal Martínez

Role: primary

Natalia Alonso

Role: primary

José Antonio Queizán Hernández

Role: primary

Carmen Couto

Role: primary

José González Campos

Role: primary

Marta Cervera

Role: primary

Ferran Vall-Llovera Calmet

Role: primary

Ana Sebrango Sadia

Role: primary

Xavier Ortin Font

Role: primary

Aurelio López

Role: primary

Mar Tormo

Role: primary

María José Sayas

Role: primary

María Pedreño

Role: primary

Magdalena Sánchez

Role: primary

Pau Montesinos

Role: primary

María Jesús Peñarrubia

Role: primary

Alberto Cantalapiedra

Role: primary

Ángeles Fernández Fernández

Role: primary

Esmeralda Benítez

Role: primary

Magdalena Sierra Pacho

Role: primary

Mayte Olave

Role: primary

Beatriz de Rueda

Role: primary

Related Links

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https://www.fundacionpethema.es

Web page of the sponsor of the study

Other Identifiers

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PETHEMA LAL-2019

Identifier Type: -

Identifier Source: org_study_id

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