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Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation

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ClinicalTrials.gov Identifier: NCT02659657
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaojun Huang,MD, 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.

Condition or disease Intervention/treatment Phase
Acute Graft-versus-host Disease Drug: Interleukin-2 Phase 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylaxis Roles of Low Dose of IL-2 Treatment on GVHD After Haploidentical Transplantation
Actual Study Start Date : March 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021


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 Name: IL-2




Primary Outcome Measures :
  1. II-IV acute graft-versus-host disease (aGVHD) post transplantation [ Time Frame: Day 100 post transplantation ]
    cumultive incidence of II-IV acute graft-versus-host disease (aGVHD) post transplantation


Secondary Outcome Measures :
  1. Severe chronic GVHD post transplantation [ Time Frame: 1 year post transplantation ]
    cumulative incidence of severe chronic GVHD post transplantation

  2. CMV infection post transplantation [ Time Frame: Day 100 post transplantation ]
    cumulative incidence of CMV infection post transplantation

  3. Measureable residual disease (MRD)-positive test post transplantation [ Time Frame: 1 year ]
    cumulative incidence of MRD+ post transplantation

  4. Hematological relapse post transplantation [ Time Frame: 1 year ]
    Cumulative incidence of hematological relapse post transplantation

  5. Disease-free free survival post transplantation [ Time Frame: 1 year ]
    Cumulative incidence of DFS post transplantation

  6. Overall survival post transplantation [ Time Frame: 1 year ]
    Cumulative incidence of OS post transplantation



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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659657


Contacts
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Contact: Xiangyu Zhao +861088324576 zhao_xy@bjmu.edu.cn
Contact: Xiaosu Zhao +861088324576 zhao.xiaosu@outlook.com

Locations
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China, Beijing
Peking University Institute of Hematology Recruiting
Beijing, Beijing, China, 100044
Contact: Xiangyu Zhao, M.D., PhD    +861088325949    xyz80421@126.com   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Xiaojun Huang Peking University Intitute of Hematology
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Responsible Party: Xiaojun Huang,MD, Chief of Peking University Institute of Hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02659657    
Other Study ID Numbers: 2016PHB006-01
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs