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Recruiting NCT04179929

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

No phase Interventional Acute Lymphoblastic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pediatric-type of chemotherapy, allogeneic HSCT.
Who it may be relevant to
Registry conditions: Acute Lymphoblastic Leukemia. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Overall survival [Time frame: 3 years]
Secondary outcome measures (2)
  • Complete remission (CR) rate [Time frame: 4 or 8 weeks after treatment onset]
  • MRD status after induction and consolidation [Time frame: After induction (4-8 weeks) and consolidation (16-20 weeks)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 108 centers
  • Ico-Hugtip — Badalona
  • H. A Coruña — A Coruña
  • H Albacete — Albacete
  • H. General Univ. de Alicante — Alicante
  • H. General Univ. de Alicante — Alicante
  • Hospital Nuestra Señora de Sonsoles — Ávila
  • Clínica Teknon — Barcelona
  • H del Mar — Barcelona
  • … and 100 more centers

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-C PMID 42081455

Identifiers

NCT: NCT04179929 · PETHEMA LAL-2019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗