Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults
Treatment of BCR-ABL Negative ALL in Adults According to MRD and Genetics
PETHEMA Foundation
300 participants
Nov 25, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria7
- 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.
Interventions
Pediatric type chemotherapy (induction, early and delayed consolidation, reinduction, maintenance). Induction (VCR,PDN,PegASP,DNR). Early and delayed consolidation (high-dose Methotrexate, high-dose Cytarabine, PegASP). Reinduction (VCR, PDN, PegASP, DNR). Maintenance (Methotrexate, Mercaptopurine)
allogeneic HSCT
Locations(108)
View Full Details on ClinicalTrials.gov
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NCT04179929