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

PETHEMA Foundation

Status: Enrolling

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: Pediatric-type of chemotherapy; Procedure: allogeneic HSCT

Study type: Interventional

Funder types: Other

Identifiers

NCT04179929

PETHEMA LAL-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

CHEMOTHERAPY

Other group

Description:

Pediatric-type of chemotherapy

Treatment:

Drug: Pediatric-type of chemotherapy

allogeneic HSCT

Other group

Description:

allogeneic HSCT

Treatment:

Procedure: allogeneic HSCT