Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Graft-versus-host Disease
• Intervention / Treatment: Drug: Interleukin-2

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University Institute of Hematology
      • Contact: Xiangyu Zhao, M.D., PhD; Phone Number: +861088325949; Email: xyz80421@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interleukin-2 interventions; 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).	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); Other Names: IL-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Xiaojun Huang, Peking University Intitute of Hematology

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2015
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: January 15, 2016
• First Posted (ESTIMATE): January 20, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antineoplastic Agents; Interleukin-2
• Other Study ID Numbers: 2016PHB006-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO