Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults
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.
| Condition(s) | Acute Lymphoblastic Leukemia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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. |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Lead sponsor | PETHEMA Foundation |
| Locations | Badalona, Barcelona, Spain; A Coruña, Spain; Albacete, Spain; Alicante, Spain; Alicante, Spain; Ávila, Spain (+102 more sites) |
| Start date | 2019-11-25 |
| NCT ID | NCT04179929 |
| Official listing | https://clinicaltrials.gov/study/NCT04179929 |