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Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation

Primary Purpose

Acute Graft-versus-host Disease

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Interleukin-2
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Graft-versus-host Disease

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Peking University Institute of HematologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interleukin-2 interventions

Arm Description

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).

Outcomes

Primary Outcome Measures

II-IV acute graft-versus-host disease (aGVHD) post transplantation
cumultive incidence of II-IV acute graft-versus-host disease (aGVHD) post transplantation

Secondary Outcome Measures

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

Full Information

First Posted
January 8, 2016
Last Updated
September 30, 2020
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02659657
Brief Title
Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation
Official Title
Prophylaxis Roles of Low Dose of IL-2 Treatment on GVHD After Haploidentical Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Graft-versus-host Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interleukin-2 interventions
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Interleukin-2
Other Intervention Name(s)
IL-2
Intervention Description
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)
Primary Outcome Measure Information:
Title
II-IV acute graft-versus-host disease (aGVHD) post transplantation
Description
cumultive incidence of II-IV acute graft-versus-host disease (aGVHD) post transplantation
Time Frame
Day 100 post transplantation
Secondary Outcome Measure Information:
Title
Severe chronic GVHD post transplantation
Description
cumulative incidence of severe chronic GVHD post transplantation
Time Frame
1 year post transplantation
Title
CMV infection post transplantation
Description
cumulative incidence of CMV infection post transplantation
Time Frame
Day 100 post transplantation
Title
Measureable residual disease (MRD)-positive test post transplantation
Description
cumulative incidence of MRD+ post transplantation
Time Frame
1 year
Title
Hematological relapse post transplantation
Description
Cumulative incidence of hematological relapse post transplantation
Time Frame
1 year
Title
Disease-free free survival post transplantation
Description
Cumulative incidence of DFS post transplantation
Time Frame
1 year
Title
Overall survival post transplantation
Description
Cumulative incidence of OS post transplantation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 15-65 years old Acute leukemia in complete remission (CR1/CR2) who received myeloablative haploidentical allo-HSCT WBC engraftment (ANC>500/ul for continuous 3 days) At least +7d Less than or equal to +15d non T-ALL no active II-IV aGVHD no severe infections Karnofsky score greater than or equal to 90% Haploidentical donor from sibling, children or father Ensure that informed consent signed and faxed to Research Coordinator Exclusion Criteria: Exposure to any other clinical trials prior to enrollment Active malignant disease relapses or MRD positive Active, uncontrolled infection Inability to comply with IL-2 treatment regimen Active, uncontrolled II-IV aGVHD Haploidentical donor from mother or collateral donors Clinical Signs of severe pulmonary dysfunction Clinical Signs of sever cardiac dysfunction Receiving corticosteroids as GVHD treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangyu Zhao
Phone
+861088324576
Email
zhao_xy@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaosu Zhao
Phone
+861088324576
Email
zhao.xiaosu@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojun Huang
Organizational Affiliation
Peking University Intitute of Hematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Institute of Hematology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangyu Zhao, M.D., PhD
Phone
+861088325949
Email
xyz80421@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation

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