Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation

Phase 2

• Conditions: Acute Graft-versus-host Disease
• Interventions: Drug: Interleukin-2

• Registration Number: NCT02659657
• Lead Sponsor: Peking University People's Hospital

Brief 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.

Detailed Description

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.low dose of IL-2 (40 million U/m2) will be administered from WBC engraftment to day 90 post haploidentical transplantation. IL-2 will be administered three times a week.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-15
• Study First Posted: 2016-01-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-01
• Primary Completion: 2021-06
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interleukin-2 interventions	Interleukin-2	Patients with standard risk hematologic malignancies undergoing an unmodified haploidentical HCT will be eligible. Once patients achieved neutrophil engraftment will be given IL-2, 0.4×10E+6/M2/d, 3 times a week (separated by at least 1 day between injections) until day +90 (+/- 7 days).

Primary Outcome Measures

Name	Time	Method
II-IV acute graft-versus-host disease (aGVHD) post transplantation	Day 100 post transplantation	cumultive incidence of II-IV acute graft-versus-host disease (aGVHD) post transplantation

Secondary Outcome Measures

Name	Time	Method
Overall survival post transplantation	1 year	Cumulative incidence of OS post transplantation
CMV infection post transplantation	Day 100 post transplantation	cumulative incidence of CMV infection post transplantation
Measureable residual disease (MRD)-positive test post transplantation	1 year	cumulative incidence of MRD+ post transplantation
Disease-free free survival post transplantation	1 year	Cumulative incidence of DFS post transplantation
Severe chronic GVHD post transplantation	1 year post transplantation	cumulative incidence of severe chronic GVHD post transplantation
Hematological relapse post transplantation	1 year	Cumulative incidence of hematological relapse post transplantation

Trial Locations

Locations (1)

Peking University Institute of Hematology; 🇨🇳 Beijing, Beijing, China