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

Conditions

Acute Lymphoblastic Leukemia

Keywords

ALL, adult, Ph-negative, minimal residual disease, transplantation

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.

Anna Torrent, Mireia Morgades, Susana Barrera, Jordi Ribera, Eulàlia Genescà et al. (50 authors)

Blood2025-11-03

10.1182/blood-2025-1564

Combination of genetics at baseline and clearance of MRD to assign the post-remission treatment of patients with Philadelphia-negative ACUTE lymphoblastic leukemia. FINAL results of pethema LAL19 trial

Anna Torrent, Mireia Morgades, Susana Barrera, Jordi Ribera, Eulàlia Genescà et al. (50 authors)

Blood2025-11-03

10.1182/blood-2025-5121

Dissecting the Role of Acquired Regions of Homozygosity Detected By Microarray Along the Genome of a Large Cohort of Adult Patients with B-Cell Precursor Acute Lymphoblastic Leukemia

Gianfranco Lapietra, Jordi Ribera, Mireia Morgades, Neus Ruiz Xiville, Anna Torrent et al. (15 authors)

Blood2024-11-05

10.1182/blood-2024-208425

IKZF1 Deletions Are Markers of Treatment Resistance in Adult Ph-Negative B-Cell Acute Lymphoblastic Leukemia Patients Treated within the Ongoing Risk-Adapted Pethema LAL19 Trial

Jordi Ribera, Isabel Granada, Teresa González, Mireia Morgades, Olga García et al. (23 authors)

Blood2022-11-151 citations

10.1182/blood-2022-162159

Interventions

DRUGPediatric-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)

PROCEDUREallogeneic HSCT

allogeneic HSCT

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Overall survival	3 years	Time from diagnosis to death or last follow-up

Secondary

Measure	Time frame	Description
Complete remission (CR) rate	4 or 8 weeks after treatment onset	Proportion of patients who achieve CR with or 2 induction therapy lines
MRD status after induction and consolidation	After induction (4-8 weeks) and consolidation (16-20 weeks)	Proportion of patients who achieve and maintain the negative MRD status (\<10-4)

Other

Measure	Time frame	Description
alloSCT realization	Early alloHSCT: 15-20 weeks from diagnosis. Delayed: 30-35 weeks from diagnosis.	Proportion of patients who receive early or delayed alloHSCT

Countries

Spain

Contacts

Primary ContactJosep Maria Ribera, Ph

jribera@iconcologia.net934978987

Outcome results

None listed