Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation

Acute Graft-versus-host Disease Clinical Trial

Official title:

Prophylaxis Roles of Low Dose of IL-2 Treatment on GVHD After Haploidentical Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02659657
• Other study ID #: 2016PHB006-01
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: December 2021

Study information

• Verified date: September 2020
• Source: Peking University People's Hospital
• Contact: Xiangyu Zhao
• Phone: +861088324576
• Email: zhao_xy[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Graft-versus-host Disease
• Graft vs Host Disease

Intervention

Drug:
• Interleukin-2
Interleukin-2 (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)

Locations

Country	Name	City	State
China	Peking University Institute of Hematology	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	II-IV acute graft-versus-host disease (aGVHD) post transplantation	cumultive incidence of II-IV acute graft-versus-host disease (aGVHD) post transplantation	Day 100 post transplantation
Secondary	Severe chronic GVHD post transplantation	cumulative incidence of severe chronic GVHD post transplantation	1 year post transplantation
Secondary	CMV infection post transplantation	cumulative incidence of CMV infection post transplantation	Day 100 post transplantation
Secondary	Measureable residual disease (MRD)-positive test post transplantation	cumulative incidence of MRD+ post transplantation	1 year
Secondary	Hematological relapse post transplantation	Cumulative incidence of hematological relapse post transplantation	1 year
Secondary	Disease-free free survival post transplantation	Cumulative incidence of DFS post transplantation	1 year
Secondary	Overall survival post transplantation	Cumulative incidence of OS post transplantation	1 year