NCT02659657

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

6.3 years

First QC Date

January 8, 2016

Last Update Submit

September 30, 2020

Conditions

Acute Graft-versus-host Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Severe chronic GVHD post transplantation

    1 year post transplantation

  • CMV infection post transplantation

    Day 100 post transplantation

  • Measureable residual disease (MRD)-positive test post transplantation

    1 year

  • Hematological relapse post transplantation

    1 year

  • Disease-free free survival post transplantation

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Interleukin-2 interventions

EXPERIMENTAL

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

Interventions

Interleukin-2DRUG

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)

Also known as: IL-2
Interleukin-2 interventions

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Institute of Hematology

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Interventions

Interleukin-2

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • Xiaojun Huang

    Peking University Intitute of Hematology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangyu Zhao

CONTACT

+861088324576zhao_xy@bjmu.edu.cn

Xiaosu Zhao

CONTACT

+861088324576zhao.xiaosu@outlook.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Peking University Institute of Hematology

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 20, 2016

Study Start

March 1, 2015

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

October 1, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)