Clinical trial NCT02659657: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Graft-versus-host Disease
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 70
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: II-IV acute graft-versus-host disease (aGVHD) post transplantation
timeFrame: Day 100 post transplantation
Secondary outcomes:
measure: Severe chronic GVHD post transplantation
timeFrame: 1 year post transplantation
measure: CMV infection post transplantation
timeFrame: Day 100 post transplantation
measure: Measureable residual disease (MRD)-positive test post transplantation
timeFrame: 1 year
measure: Hematological relapse post transplantation
timeFrame: 1 year
measure: Disease-free free survival post transplantation
timeFrame: 1 year
measure: Overall survival post transplantation
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Hematology
state: Beijing
Study officials:
affiliation: Peking University Intitute of Hematology
name: Xiaojun Huang
role: PRINCIPAL_INVESTIGATOR
References: