NCT04179929 Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults
| NCT ID | NCT04179929 |
| Status | Recruiting |
| Phase | — |
| Sponsor | PETHEMA Foundation |
| Condition | Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2019-11-25 |
| Primary Completion | 2026-11 |
Trial Parameters
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Brief 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 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.
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