NCT03297528

Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant

Multiple Consolidation Chemotherapy and DLI Prevent Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant and Achieving Complete Remission After Induction Chemotherapy and DLI

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Patients with acute leukemia relapsing after allotransplant and who respond to anti-leukaemia interventions are at high-risk of a second relapse. Previous studies from investigators reported an association between a positive minimal residual disease (MRD)-test after transplant and an increased risk of subsequent relapse. Also, patients developing chronic graft-versus-host disease (GvHD) after receiving DLI (donor lymphocyte infusion)for leukemia relapse after a first allotransplant have a lower likelihood of a second relapse compared with similar patients not developing chronic GvHD. And, our previous study also reported patients with chronic GvHD after DLI was associated with a greater frequency of a negative MRD-test and lower likelihood of subsequent relapse compared with similar persons not developing chronic GvHD. Based on these data the investigators designed a randomized control study to determine whether giving additional consolidation chemotherapy and DLI might decrease likelihood of second relapse in persons without chronic GvHD or with a positive MRD-test after initial post-relapse therapy with induction chemotherapy and DLI.

Conditions

• Donor Lymphocyte Infusion
• Allogeneic Hematopoietic Stem Cell Transplantation
• Acute Leukemia
• Minimal Residual Disease
• Graft-versus-host Disease
• Relapse

Interventions

Type	Name	Description
DRUG	donor lymphocyte infusion	Participants in study group receive chemotherapy and donor lymphocyte infusion based on the state of GvHD, even they have a negative result of MRD. If participants in study group have no GvHD, they will receive chemotherapy and donor lymphocyte infusion until they develop GvHD. If the participants in study group have GvHD, they will be observed. But, the participants in control group don't receive chemotherapy and donor lymphocyte infusion as long as they have a negative result of MRD, in despite of whether or not GvHD.

Timeline

• Start date: 2017-03-01
• Primary completion: 2020-10-01
• Completion: 2021-10-01
• First posted: 2017-09-29
• Last updated: 2020-03-10

Locations

1 site across 1 country: China