Acute Graft-versus-host DiseasePhase 2NCT02659657
Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation
A Phase 2 study testing Interleukin-2 in people with Acute Graft-versus-host Disease, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Graft-versus-host Disease
- What is being tested?
- Interleukin-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Clinical Signs of severe pulmonary dysfunction
- Clinical Signs of sever cardiac dysfunction
- Receiving corticosteroids as GVHD treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Institute of Hematology
Beijing, Beijing Municipality, 100044
Xiangyu Zhao, M.D., PhD, +861088325949, xyz80421@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Graft-versus-host Disease
- Being tested
- Interleukin-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-2Drug
Also called IL-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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
II-IV acute graft-versus-host disease (aGVHD) post transplantation
cumultive incidence of II-IV acute graft-versus-host disease (aGVHD) post transplantation
Measured: Day 100 post transplantation
Secondary outcomes (6)
Severe chronic GVHD post transplantation
cumulative incidence of severe chronic GVHD post transplantation
Measured: 1 year post transplantation
CMV infection post transplantation
cumulative incidence of CMV infection post transplantation
Measured: Day 100 post transplantation
Measureable residual disease (MRD)-positive test post transplantation
cumulative incidence of MRD+ post transplantation
Measured: 1 year
Hematological relapse post transplantation
Cumulative incidence of hematological relapse post transplantation
Measured: 1 year
Disease-free free survival post transplantation
Cumulative incidence of DFS post transplantation
Measured: 1 year
Overall survival post transplantation
Cumulative incidence of OS post transplantation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startMar 2015
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft-versus-host DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Huang,MD, Peking University People's Hospital
- Investigators
- Xiaojun Huang, Principal investigator, Peking University Intitute of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659657
- Sponsor's protocol ID
- 2016PHB006-01
- Status last verified
- Sep 2020
- First submitted
- 8 Jan 2016
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis Roles of Low Dose of IL-2 Treatment on GVHD After Haploidentical Transplantation
- ClinicalTrials.gov ID
- NCT02659657
- Acronym / sponsor ID
- 2016PHB006-01
- Conditions
- Acute Graft-versus-host Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interleukin-2 interventions | Experimental | Drug: Interleukin-2Patients 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). |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interleukin-2Also: IL-2Interleukin-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) | Drug | Interleukin-2 interventions |
Primary outcome
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
6 secondary outcomes
Severe chronic GVHD post transplantation
Time frame: 1 year post transplantation
CMV infection post transplantation
Time frame: Day 100 post transplantation
Measureable residual disease (MRD)-positive test post transplantation
Time frame: 1 year
Hematological relapse post transplantation
Time frame: 1 year
Disease-free free survival post transplantation
Time frame: 1 year
Overall survival post transplantation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaojun Huang principal investigator
Peking University Intitute of Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interleukin-2 in people with Acute Graft-versus-host Disease, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangyu Zhao (+861088324576, zhao_xy@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
II-IV acute graft-versus-host disease (aGVHD) post transplantation (time frame: Day 100 post transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.