Minimal Residual Disease,Acute Leukemia, Hypomethylating Agents, Donor Lymphocyte Infusion, Allogeneic Hematopoietic Cell Transplantation
Conditions
Brief summary
Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse is the most common problem affecting long-term survivors of allo-HSCT. Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI) or combination therapy. In this prospective randomized controlled study, the safety and efficacy of hypomethylating agents (HMA) + DLI and DLI preemptive therapy based on minimal residual disease in acute leukemia undergoing allo-HSCT are evaluated.
Detailed description
Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse is the most common problem affecting long-term survivors of allo-HSCT. Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI) or combination therapy. One method of solving relapse is to intervene before hematologic or pathologic relapse occurs based on minimal residual disease (MRD) . DLI is an effective post-transplantation therapy based on MRD for relapse. Whether combination of hypomethylating agents (HMA) and DLI could improve outcomes remains unclear. In this prospective randomized controlled study, the safety and efficacy of HMA+DLI and DLI preemptive therapy based on minimal residual disease in acute leukemia undergoing allo-HSCT are evaluated.
Interventions
COMBINATION_PRODUCTHMA+DLI
HMA: Decitabine was administered at 20mg/m2/day for five consecutive days or Ara-C was administered at 75mg/m2/day for seven consecutive days. DLI was administered at a median dose of 1.0 (range 0.7-1.4) ×10\*8 mononuclear cells/kg.
BIOLOGICALDLI
DLI was administered at a median dose of 1.0 (range 0.7-1.4) ×10\*8 mononuclear cells/kg.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- A patient age of 14-65 years. AL patients who achieved CR at pre-transplantation undergoing allo-HSCT. Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion criteria
* AL patients who were in NR at pre-transplantation undergoing allo-HSCT. 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 | Description |
|---|---|---|
| Relapse | 2 years | Relapse was defined by reappearance of blasts in the peripheral blood, recurrence of BM blasts \>5%, or development of extramedullary disease infiltrates at any site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival (DFS) | 2 years | DFS was defined as the time from transplantation to relapse or death in remission |
| Overall survival (OS) | 2 years | OS was defined as the time from transplantation to death from all causes |
| Transplant-related mortality (TRM) | 2 years | TRM was defined as death from any cause except relapse |
| Incidence of acute GVHD | 100 days | Acute GVHD was graded according to standard criteria |
| Incidence of chronic GVHD | 2 years | Chronic GVHD was assessed in patients alive after day 100 |
Countries
China
Contacts
Primary ContactHua Jin
Outcome results
None listed