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

  • STATUS
    Recruiting
  • End date
    Feb 22, 2027
  • participants needed
    300
  • sponsor
    PETHEMA Foundation
Updated on 22 February 2021
cell transplantation
residual tumor
consolidation therapy

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.

Details
Condition childhood ALL, Lymphocytic Leukemia, Acute, acute lymphoblastic leukemia, leukemia, acute lymphoblastic, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all)
Treatment allogeneic HSCT, Pediatric-type of chemotherapy
Clinical Study IdentifierNCT04179929
SponsorPETHEMA Foundation
Last Modified on22 February 2021

Eligibility

Yes No Not Sure

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
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