Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation

NCT ID: NCT02659657

Last Updated: 2020-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Acute Graft-versus-host Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Interleukin-2

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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IL-2

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiaojun Huang,MD

Chief of Peking University Institute of Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaojun Huang

Role: PRINCIPAL_INVESTIGATOR

Peking University Intitute of Hematology

Locations

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Peking University Institute of Hematology

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangyu Zhao

Role: CONTACT

+861088324576

Xiaosu Zhao

Role: CONTACT

+861088324576

Facility Contacts

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Xiangyu Zhao, M.D., PhD

Role: primary

+861088325949

Other Identifiers

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2016PHB006-01

Identifier Type: -

Identifier Source: org_study_id

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