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.
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
Drug | Synonyms | Arms |
---|
Pediatric-type of chemotherapy | | CHEMOTHERAPY |
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
Name | Type | Description | Interventions |
---|
CHEMOTHERAPY | Other | Pediatric-type of chemotherapy | - Pediatric-type of chemotherapy
|
allogeneic HSCT | Other | allogeneic 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: | Recruiting |
Lead Sponsor: | PETHEMA Foundation |
Trial Keywords
- ALL
- adult
- Ph-negative
- minimal residual disease
- transplantation
Last Updated
February 16, 2021