Minimal Residual Disease, Donor Lymphocyte Infusion, Hematopoietic Stem Cell Transplantation, Relapse
Conditions
Brief summary
Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse remains an important problem. Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI), and another transplantation used alone or in combination. However, the efficacy of these interventions is limited. One approach to the relapse problem is to intervene before hematologic or pathologic relapse occurs based on minimal residual disease (MRD). In this study, the efficacy of MRD-directed DLI on transplantation outcomes will be evaluated in patients with acute leukemia receiving allo-HSCT.
Detailed description
Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse remains an important problem. Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI), and another transplantation used alone or in combination. However, the efficacy of these interventions is limited. One approach to the relapse problem is to intervene before hematologic or pathologic relapse occurs based on minimal residual disease (MRD) using immune or molecular techniques.DLI is an effective post-transplantation therapy for prophylaxis of leukemia relapse, but is associated with a substantial risk of GVHD. Whether MRD-directed DLI could improve outcomes remains unclear. In this study, the efficacy of MRD-directed DLI on transplantation outcomes will be evaluated in patients with acute leukemia receiving allo-HSCT.
Interventions
DLI was administered at a median dose of 1.0 (range 0.7-1.4) ×10\*8 mononuclear cells/kg.
Sponsors
Study design
Eligibility
Inclusion criteria
* patients with acute leukemia * receiving allo-HSCT
Exclusion criteria
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relapse rate | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | 1 year |
| disease-free survival | 1 year |
Countries
China