Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow transplantation (HBMT) on hematological malignancies are well established.The aim of this prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be decreased with IL2 therapy post HBMT.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

1. Aged 15-65 years old

2. Acute leukemia in complete remission (CR1/CR2) who received myeloablative haploidentical allo-HSCT

3. WBC engraftment (ANC>500/ul for continuous 3 days)

4. At least +7d

5. Less than or equal to +15d

6. non T-ALL

7. no active II-IV aGVHD

8. no severe infections

9. Karnofsky score greater than or equal to 90%

10. Haploidentical donor from sibling, children or father

11. Ensure that informed consent signed and faxed to Research Coordinator

Exclusion Criteria:

1. Exposure to any other clinical trials prior to enrollment

2. Active malignant disease relapses or MRD positive

3. Active, uncontrolled infection

4. Inability to comply with IL-2 treatment regimen

5. Active, uncontrolled II-IV aGVHD

6. Haploidentical donor from mother or collateral donors

7. Clinical Signs of severe pulmonary dysfunction

8. Clinical Signs of sever cardiac dysfunction

9. Receiving corticosteroids as GVHD treatment