Clinical trial NCT04179929: Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults
Official title: Treatment of BCR-ABL Negative ALL in Adults According to MRD and Genetics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Keywords: ALL
adult
Ph-negative
minimal residual disease
transplantation
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Complete remission (CR) rate
timeFrame: 4 or 8 weeks after treatment onset
measure: MRD status after induction and consolidation
timeFrame: After induction (4-8 weeks) and consolidation (16-20 weeks)
Other outcomes:
measure: alloSCT realization
timeFrame: Early alloHSCT: 15-20 weeks from diagnosis. Delayed: 30-35 weeks from diagnosis.
Locations:
city: Badalona
country: Spain
facility: Ico-Hugtip
state: Barcelona
city: Albacete
country: Spain
facility: H Albacete
city: Alicante
country: Spain
facility: H. General Univ. de Alicante
city: Alicante
country: Spain
facility: H. General Univ. de Alicante
city: Barcelona
country: Spain
facility: Clínica Teknon
city: Barcelona
country: Spain
facility: H del Mar
city: Barcelona
country: Spain
facility: H. Clínic de Barcelona
city: Barcelona
country: Spain
facility: H. del Mar
city: Barcelona
country: Spain
facility: H. Sant Pau
city: Barcelona
country: Spain
facility: H. Vall d'Hebron
city: Barcelona
country: Spain
facility: H. Vall d'Hebron
city: Bellvitge
country: Spain
facility: ICO-Duran i Reynals
city: Bilbao
country: Spain
facility: H Basurto
city: Bilbao
country: Spain
facility: Hu Basurto
city: Cadiz
country: Spain
facility: H. Jerez
city: Cadiz
country: Spain
facility: H. Puerta del Mar
city: Castelló
country: Spain
facility: H. General de Castellón
city: Cáceres
country: Spain
facility: H. San Pedro de Alcántara
city: Córdoba
country: Spain
facility: H. Reina Sofía
city: Fuenlabrada
country: Spain
facility: H. Fuenlabrada
city: Galdakao
country: Spain
facility: H Galdakao
city: Getafe
country: Spain
facility: H. Univ. De Getafe
city: Girona
country: Spain
facility: ICO-Dr.Josep Trueta
city: Guadalajara
country: Spain
facility: H. Guadalajara
city: Huelva
country: Spain
facility: H Juan Ramón Jiménez
city: Jaén
country: Spain
facility: Complejo Hospitalario Ciudad de Jaén
city: Jerez De La Frontera
country: Spain
facility: H. Jerez de la Frontera
city: La Coruña
country: Spain
facility: H. A Coruña
city: Lanzarote
country: Spain
facility: H. General Lanzarote
city: Las Palmas De Gran Canaria
country: Spain
facility: H Dr. Negrín
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Insular de Gran Canaria
city: Las Palmas De Gran Canaria
country: Spain
facility: Hu Gran Canarias Dr Negrin
city: Lleida
country: Spain
facility: H. Arnau De Vilanova
city: Lugo
country: Spain
facility: H. Lucus Augusti
city: Lugo
country: Spain
facility: H. Lucus Augusti
city: Lugo
country: Spain
facility: H. Lucus Augusti
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: H La Zarzuela
city: Madrid
country: Spain
facility: H Puerta de Hierro
city: Madrid
country: Spain
facility: H Puerta de Hierro
city: Madrid
country: Spain
facility: H. 12 de Octubre
city: Madrid
country: Spain
facility: H. 12 de Octubre
city: Madrid
country: Spain
facility: H. 12 de Octubre
city: Madrid
country: Spain
facility: H. 12 de Octubre
city: Madrid
country: Spain
facility: H. 12 de Octubre
city: Madrid
country: Spain
facility: H. Clínico de Madrid
city: Madrid
country: Spain
facility: H. Clínico de Madrid
city: Madrid
country: Spain
facility: H. Gregorio Marañón
city: Madrid
country: Spain
facility: H. Gregorio Marañón
city: Madrid
country: Spain
facility: H. Infanta Sofía
city: Madrid
country: Spain
facility: H. Madrid-Norte Sanchinarro
city: Madrid
country: Spain
facility: H. Ramón y Cajal
city: Madrid
country: Spain
facility: H. Ramón y Cajal
city: Madrid
country: Spain
facility: H. Univ La Paz
city: Madrid
country: Spain
facility: Hu Infanta Leonor
city: Madrid
country: Spain
facility: Hu La Princesa
city: Murcia
country: Spain
facility: H. Morales Meseguer
city: Murcia
country: Spain
facility: H. Virgen de la Arrixaca
city: Murcia
country: Spain
facility: H. Virgen de la Arrixaca
city: Murcia
country: Spain
facility: H. Virgen de la Arrixaca
city: Málaga
country: Spain
facility: H. Carlos Haya
city: Málaga
country: Spain
facility: H. Clínico Univ. Virgen de la Victoria
city: Málaga
country: Spain
facility: H. Regional de Málaga
city: Orense
country: Spain
facility: Complejo Hosp. Univ. de Orense
city: Orense
country: Spain
facility: Complejo Hosp. Univ. de Orense
city: Orense
country: Spain
facility: Complejo Hosp. Univ. de Orense
city: Orense
country: Spain
facility: Complejo Hosp. Univ. de Orense
city: Oviedo
country: Spain
facility: H. Central de Asturias
city: Palencia
country: Spain
facility: H Río Carrión
city: Palma De Mallorca
country: Spain
facility: H. Son Espases
city: Palma De Mallorca
country: Spain
facility: H. Son Llàtzer
city: Pamplona
country: Spain
facility: Complejo Hospitalario Navarra
city: Pamplona
country: Spain
facility: H. Clínico Univ. de Navarra
city: Pamplona
country: Spain
facility: H. Virgen del Camino
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Pontevedra - Hospital Montecelo
city: Sabadell
country: Spain
facility: H. Parc Taulí
city: Salamanca
country: Spain
facility: H. Clínico Univ. de Salamanca
city: Salamanca
country: Spain
facility: H. Clínico Univ. de Salamanca
city: San Sebastián
country: Spain
facility: H Donostia
city: San Sebastián
country: Spain
facility: H Donostia
city: San Sebastián
country: Spain
facility: H Donostia
city: San Sebastián
country: Spain
facility: H Donostia
city: Santa Cruz De Tenerife
country: Spain
facility: H. Univ. de Canarias
city: Santander
country: Spain
facility: H. Marqués de Valdecilla
city: Santander
country: Spain
facility: H. Marqués de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Complejo Hosp. Univ. Santiago de Compostela
city: Santiago De Compostela
country: Spain
facility: Complejo Hosp. Univ. Santiago de Compostela
city: Segovia
country: Spain
facility: H. General de Segovia
city: Sevilla
country: Spain
facility: H. Universitario de Valme
city: Sevilla
country: Spain
facility: H. Virgen del Rocío
city: Tarragona
country: Spain
facility: ICO-Joan XXIII
city: Terrassa
country: Spain
facility: Mútua de Terrassa
city: Torrejón De Ardoz
country: Spain
facility: H Torrejón
city: Tortosa
country: Spain
facility: H. Verge de la Cinta
city: Valencia
country: Spain
facility: H. Arnau de Vilanova
city: Valencia
country: Spain
facility: H. Clínico Univ. de Valencia
city: Valencia
country: Spain
facility: H. Dr. Peset
city: Valencia
country: Spain
facility: H. Dr. Peset
city: Valencia
country: Spain
facility: H. General Univ. de Valencia
city: Valencia
country: Spain
facility: H. la Fe
city: Valladolid
country: Spain
facility: H. Clínico Universitario de Valladolid
city: Valladolid
country: Spain
facility: H. Río Hortega
city: Vigo
country: Spain
facility: H. Xeral-Cíes Vigo
city: Vigo
country: Spain
facility: H. Xeral-Cíes Vigo
city: Zamora
country: Spain
facility: H. Virgen de la Concha
city: Zaragoza
country: Spain
facility: H. Lozano Blesa
city: Zaragoza
country: Spain
facility: H. Miguel Servet
city: Ávila
country: Spain
facility: Hospital Nuestra Señora de Sonsoles
Study officials:
References: