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

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

Recruiting
18-60 years
All
Phase N/A

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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.

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.

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 details
    Acute Lymphoblastic Leukemia

NCT04179929

PETHEMA Foundation

26 January 2024

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