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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04179929
• Other study ID #: PETHEMA LAL-2019
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: February 2027

Study information

• Verified date: February 2022
• Source: PETHEMA Foundation
• Contact: Josep Maria Ribera, Ph
• Phone: 934978987
• Email: jribera[@]iconcologia.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• 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)

Procedure:
• allogeneic HSCT
allogeneic HSCT

Locations

Country	Name	City	State
Spain	H Albacete	Albacete
Spain	H. General Univ. de Alicante	Alicante
Spain	H. General Univ. de Alicante	Alicante
Spain	Hospital Nuestra Señora de Sonsoles	Ávila
Spain	Ico-Hugtip	Badalona	Barcelona
Spain	Clínica Teknon	Barcelona
Spain	H del Mar	Barcelona
Spain	H. Clínic de Barcelona	Barcelona
Spain	H. del Mar	Barcelona
Spain	H. Sant Pau	Barcelona
Spain	H. Vall d'Hebron	Barcelona
Spain	H. Vall d'Hebron	Barcelona
Spain	ICO-Duran i Reynals	Bellvitge
Spain	H Basurto	Bilbao
Spain	Hu Basurto	Bilbao
Spain	H. San Pedro de Alcántara	Cáceres
Spain	H. Jerez	Cadiz
Spain	H. Puerta del Mar	Cadiz
Spain	H. General de Castellón	Castelló
Spain	H. Reina Sofía	Córdoba
Spain	H. Fuenlabrada	Fuenlabrada
Spain	H Galdakao	Galdakao
Spain	H. Univ. De Getafe	Getafe
Spain	ICO-Dr.Josep Trueta	Girona
Spain	H. Guadalajara	Guadalajara
Spain	H Juan Ramón Jiménez	Huelva
Spain	Complejo Hospitalario Ciudad de Jaén	Jaén
Spain	H. Jerez de la Frontera	Jerez De La Frontera
Spain	H. A Coruña	La Coruña
Spain	H. General Lanzarote	Lanzarote
Spain	H Dr. Negrín	Las Palmas De Gran Canaria
Spain	Hospital Insular de Gran Canaria	Las Palmas De Gran Canaria
Spain	Hu Gran Canarias Dr Negrin	Las Palmas De Gran Canaria
Spain	H. Arnau De Vilanova	Lleida
Spain	H. Lucus Augusti	Lugo
Spain	H. Lucus Augusti	Lugo
Spain	H. Lucus Augusti	Lugo
Spain	Fundación Jiménez Díaz	Madrid
Spain	H La Zarzuela	Madrid
Spain	H Puerta de Hierro	Madrid
Spain	H Puerta de Hierro	Madrid
Spain	H. 12 de Octubre	Madrid
Spain	H. 12 de Octubre	Madrid
Spain	H. 12 de Octubre	Madrid
Spain	H. 12 de Octubre	Madrid
Spain	H. 12 de Octubre	Madrid
Spain	H. Clínico de Madrid	Madrid
Spain	H. Clínico de Madrid	Madrid
Spain	H. Gregorio Marañón	Madrid
Spain	H. Gregorio Marañón	Madrid
Spain	H. Infanta Sofía	Madrid
Spain	H. Madrid-Norte Sanchinarro	Madrid
Spain	H. Ramón y Cajal	Madrid
Spain	H. Ramón y Cajal	Madrid
Spain	H. Univ La Paz	Madrid
Spain	Hu Infanta Leonor	Madrid
Spain	Hu La Princesa	Madrid
Spain	H. Carlos Haya	Málaga
Spain	H. Clínico Univ. Virgen de la Victoria	Málaga
Spain	H. Regional de Málaga	Málaga
Spain	H. Morales Meseguer	Murcia
Spain	H. Virgen de la Arrixaca	Murcia
Spain	H. Virgen de la Arrixaca	Murcia
Spain	H. Virgen de la Arrixaca	Murcia
Spain	Complejo Hosp. Univ. de Orense	Orense
Spain	Complejo Hosp. Univ. de Orense	Orense
Spain	Complejo Hosp. Univ. de Orense	Orense
Spain	Complejo Hosp. Univ. de Orense	Orense
Spain	H. Central de Asturias	Oviedo
Spain	H Río Carrión	Palencia
Spain	H. Son Espases	Palma De Mallorca
Spain	H. Son Llàtzer	Palma De Mallorca
Spain	Complejo Hospitalario Navarra	Pamplona
Spain	H. Clínico Univ. de Navarra	Pamplona
Spain	H. Virgen del Camino	Pamplona
Spain	Complejo Hospitalario Pontevedra - Hospital Montecelo	Pontevedra
Spain	H. Parc Taulí	Sabadell
Spain	H. Clínico Univ. de Salamanca	Salamanca
Spain	H. Clínico Univ. de Salamanca	Salamanca
Spain	H Donostia	San Sebastián
Spain	H Donostia	San Sebastián
Spain	H Donostia	San Sebastián
Spain	H Donostia	San Sebastián
Spain	H. Univ. de Canarias	Santa Cruz De Tenerife
Spain	H. Marqués de Valdecilla	Santander
Spain	H. Marqués de Valdecilla	Santander
Spain	Complejo Hosp. Univ. Santiago de Compostela	Santiago De Compostela
Spain	Complejo Hosp. Univ. Santiago de Compostela	Santiago De Compostela
Spain	H. General de Segovia	Segovia
Spain	H. Universitario de Valme	Sevilla
Spain	H. Virgen del Rocío	Sevilla
Spain	ICO-Joan XXIII	Tarragona
Spain	Mútua de Terrassa	Terrassa
Spain	H Torrejón	Torrejón De Ardoz
Spain	H. Verge de la Cinta	Tortosa
Spain	H. Arnau de Vilanova	Valencia
Spain	H. Clínico Univ. de Valencia	Valencia
Spain	H. Dr. Peset	Valencia
Spain	H. Dr. Peset	Valencia
Spain	H. General Univ. de Valencia	Valencia
Spain	H. la Fe	Valencia
Spain	H. Clínico Universitario de Valladolid	Valladolid
Spain	H. Río Hortega	Valladolid
Spain	H. Xeral-Cíes Vigo	Vigo
Spain	H. Xeral-Cíes Vigo	Vigo
Spain	H. Virgen de la Concha	Zamora
Spain	H. Lozano Blesa	Zaragoza
Spain	H. Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	alloSCT realization	Proportion of patients who receive early or delayed alloHSCT	Early alloHSCT: 15-20 weeks from diagnosis. Delayed: 30-35 weeks from diagnosis.
Primary	Overall survival	Time from diagnosis to death or last follow-up	3 years
Secondary	Complete remission (CR) rate	Proportion of patients who achieve CR with or 2 induction therapy lines	4 or 8 weeks after treatment onset
Secondary	MRD status after induction and consolidation	Proportion of patients who achieve and maintain the negative MRD status (<10-4)	After induction (4-8 weeks) and consolidation (16-20 weeks)

External Links

•   Web page of the sponsor of the study