Clinical Trials Logo
  1. Home
  2. Acute Lymphoblastic Leukemia
  3. NCT04179929
  4. Details
NCT04179929 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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)
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Recruiting NCT05772000 - Clinical Significance of Occult Central Nervous System Localization
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Active, not recruiting NCT03114865 - A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance Phase 1/Phase 2
Not yet recruiting NCT06308588 - Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Phase 2
Recruiting NCT05579132 - A Phase Ib/II Study of CN201 in Precursor B-cell Acute Lymphoblastic Leukemia Phase 1/Phase 2
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Terminated NCT02231853 - Phase I/II Trial of Early Infusion of Rapidly-generated Multivirus Specific T Cells (MVST) to Prevent Post Transplant Viral Infections Phase 1
Recruiting NCT04969601 - Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings Phase 1/Phase 2
Recruiting NCT06195891 - Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome Phase 1
Withdrawn NCT02815059 - Study of Pts With Philadelphia Chromosome-Pos ALL With Comb of Ibrutinib, Dasatinib, and Prednisone Phase 1
Completed NCT00390793 - Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia. Phase 2
Recruiting NCT05866887 - Insomnia Prevention in Children With Acute Lymphoblastic Leukemia N/A
Completed NCT00026780 - Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Completed NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer
Not yet recruiting NCT06350994 - Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Withdrawn NCT04282174 - CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies Phase 2
Not yet recruiting NCT04488237 - Vitamin D and Methotrexate Adverse Effects
Completed NCT02544438 - Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Phase 1/Phase 2

External Links