Clinical trial · Interventional
Prophylactic Donor Lymphocyte Infusion After Allo-PBSCT for Patients With Very High-risk Hematologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Unmanipulated allogenic peripheral blood stem cell transplantation (allo-PBSCT) has been an established treatment to cure high-risk leukemia/lymphoma. Relapse is the main cause of treatment failure for patients with relapsed/refractory disease or with very high-risk gene mutations such as TP53, TET2 and DNMT3a. Donor lymphocyte infusion (DLI) is an option to reduce relapse after allo-PBSCT for very high-risk disease without effective targeted therapy. In this study, the investigators aimed to compare the safety and efficacy of prophylactic DLI with G-CSF-primed peripheral blood progenitors for prevention of relapse after allo-PBSCT in patients with very high-risk leukemia/lymphoma.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Decitabine | — | UNRESOLVED | — |
| Donor Lymphocyte Infusion | — | UNRESOLVED | — |
| Graft-versus-host Disease | — | UNRESOLVED | — |
| Peripheral Blood Stem Cell Transplantation | — | UNRESOLVED | — |
| Relapse | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic DLI | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prophylactic DLI
- description
- The scheduled time of the first prophylactic DLI was +30 \~ +60 days after transplantation for HLA-matched sibling donors (MSD)-PBSCT recipients and +60 \~ +90 days after transplantation for HLA-haploidentical sibling donors (HID)-PBSCT recipients.
- interventionNames
- Biological: Prophylactic DLI
- type
- NO_INTERVENTION
- label
- No prophylactic DLI
Primary outcomes (2)
- measure
- Cumulative incidence of relapse at 1 year after randomization
- timeFrame
- 1 year
- description
- Relapse was defined as hematologic recurrence of malignancies after transplantation. Cumulative incidence of relapse was analyzed in a competing risk framework using Gray's method.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * disease in the non-remission (NR) state prior to transplantation, including primary induction failure, relapse untreated or refractory to reinduction chemotherapy. * achieving CR1 with ≥3 cycles of induction of chemotherapy. * carrying TP53, DNMT3a, TET2 or FLT3-ITD gene mutation. Exclusion Criteria: * early relapse, either molecular relapse or hematological relapse. * primary or secondary graft failure. * concomitant uncontrolled disease and/or organ dysfunction (infection, severe heart, renal, respiratory or hepatic failure…).
References
Publications (0)
Data not yet available