Clinical trial · Interventional
Efficiency Study of Low Dose of IL-2 to Prevent Relapse in Standard Risk Leukemia After Transplantation
Low Dose of Interleukin-2 Following Allogeneic Unmanipulated Blood and Marrow Transplantation in Treating Patients With Standard Risk Hematologic Malignancy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Because the conditional power was 0.083, the Data and Safety Monitoring Board recommended halting the study due to futility after the 1st interim analysis.
Summary
Brief summary (as posted)
Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, relapse rate was still the key question to influence the overall survival after transplantation, even in standard risk leukemia.There were good evidences that natural killer cells and T regulatory cells, which were expanded and stimulated by the application of IL-2, could mediate protection against GvHD while maintaining graft anti-tumor activity as a positive side effect. Meanwhile, it was found in our previous pilot study that low-dose IL-2 subcutaneous administration from 100 days for a prolonged period could be a safe and effective strategy to prevent relapse in acute lymphoblastic malignancy patients with high risk of recurrence after unmanipulated allo-HSCT. The study hypothesis: Prevention of relapse using low dose IL-2 following hematopoietic stem cell transplantation in patients with standard risk acute leukemia can * reduce relapse rate * improve survival
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interleukin-2 | Drug | Aldesleukin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interleukin-2
- description
- Interleukin-2 post-transplantation to prevent relapse of standard risk leukemia
- interventionNames
- Drug: Interleukin-2
- type
- NO_INTERVENTION
- label
- controlled group
- description
- controlled standard risk leukemia received regular transplantation without IL-2 intervention
Primary outcomes (1)
- measure
- To determine the feasibility and efficiency of administering 6 courses of subcutaneous IL-2 in these patients population.
- timeFrame
- 2 years
- description
- investigate the incidences of severe GVHD and pancytopenia after IL-2 application to evaluate the safety of this drug. observe the drug toxicity based on common toxicity criteria (CTC,version 3.0). compare the relapse rate and incidence of positive MRD between two groups to evaluate the efficiency of IL-2 application.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Standard risk of Recipients (CR1 or CR 2 of AML/ALL before transplantation except Ph+ ALL and T-ALL) of allogeneic stem cell transplantation with myeloablative conditioning regimens * Standard risk of Recipients: CR1 or CR 2 of AML/ALL before transplantation * Ph+ ALL, AML with t(8;21) and T-ALL were excepted * Patients were at least 60 days post-transplantation * Bone marrow monitoring was still Complete Remission (CR) and minor residual disease (MRD) was negative * 15 years of age or older * No serious infection Exclusion Criteria: * Exposure to any other clinical trials prior to enrollment * Active malignant disease relapse * Active, uncontrolled infection * Inability to comply with IL-2 treatment regimen
References
Publications (0)
Data not yet available