Clinical Trials /

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

NCT04179929

Description:

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.

Related Conditions:
  • Acute Lymphoblastic Leukemia
Recruiting Status:

Not yet recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults
  • Official Title: Treatment of BCR-ABL Negative ALL in Adults According to MRD and Genetics

Clinical Trial IDs

  • ORG STUDY ID: PETHEMA LAL-2019
  • NCT ID: NCT04179929

Conditions

  • Acute Lymphoblastic Leukemia

Interventions

DrugSynonymsArms
Pediatric-type of chemotherapyCHEMOTHERAPY

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
CHEMOTHERAPYOtherPediatric-type of chemotherapy
  • Pediatric-type of chemotherapy
allogeneic HSCTOtherallogeneic HSCT

    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.
          
    Maximum Eligible Age:60 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Overall survival
    Time Frame:3 years
    Safety Issue:
    Description:Time from diagnosis to death or last follow-up

    Secondary Outcome Measures

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

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:PETHEMA Foundation

    Trial Keywords

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

    Last Updated

    December 4, 2019