Efficiency Study of Low Dose of IL-2 to Prevent Relapse in Standard Risk Leukemia After Transplantation

• Status: Terminated
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: Interleukin-2

Criteria

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