LeukemiaNCT01517347
Efficiency Study of Low Dose of IL-2 to Prevent Relapse in Standard Risk Leukemia After Transplantation
A study testing Interleukin-2 in people with Leukemia, run by Peking University People's Hospital at 1 site in China.
Trial summary
Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, relapse rate was still the key question to influence the overall survival after transplantation, even in standard risk leukemia.There were good evidences that natural killer cells… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Leukemia
- What is being tested?
- Interleukin-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Aug 2015
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Standard risk of Recipients (CR1 or CR 2 of AML/ALL before transplantation except Ph+ ALL and T-ALL) of allogeneic stem cell transplantation with myeloablative conditioning regimens
- Standard risk of Recipients: CR1 or CR 2 of AML/ALL before transplantation
- Ph+ ALL, AML with t(8;21) and T-ALL were excepted
- Patients were at least 60 days post-transplantation
- Bone marrow monitoring was still Complete Remission (CR) and minor residual disease (MRD) was negative
- 15 years of age or older
- No serious infection
Who cannot join
- Exposure to any other clinical trials prior to enrollment
- Active malignant disease relapse
- Active, uncontrolled infection
- Inability to comply with IL-2 treatment regimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose of Interleukin-2 Following Allogeneic Unmanipulated Blood and Marrow Transplantation in Treating Patients With Standard Risk Hematologic Malignancy
Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, relapse rate was still the key question to influence the overall survival after transplantation, even in standard risk leukemia.There were good evidences that natural killer cells and T regulatory cells, which were expanded and stimulated by the application of IL-2, could mediate protection against GvHD while maintaining graft anti-tumor activity as a positive side effect. Meanwhile, it was found in our previous pilot study that low-dose IL-2 subcutaneous administration from 100 days for a prolonged period could be a safe and effective strategy to prevent relapse in acute lymphoblastic malignancy patients with high risk of recurrence after unmanipulated allo-HSCT.
The study hypothesis:
Read more
Prevention of relapse using low dose IL-2 following hematopoietic stem cell transplantation in patients with standard risk acute leukemia can
- reduce relapse rate
- improve survival
Read the detailed description
Standard risk patients over 15 years old(except Ph+ ALL, AML t(8;21) and T-ALL) undergone unmanipulated blood and marrow transplantation following day 60 post-transplantation were randomized into treated group (with low dose IL-2 treatment) or controlled group (without any intervention post-transplantation). The end points were safety and clinical and immunologic response.Following time is 24 months.
Primary Outcome Measures:
*To determine the feasibility and efficacy of administering an 6 course of subcutaneous IL-2 in this patient population. [ Time Frame: 2 years ]
Secondary Outcome Measures:
*To assess the immunologic impact of ultra-low dose subcutaneous IL-2 in patients after transplantation [ Time Frame: 2 years ] Estimated Enrollment:360 Study Start Date:Jan 2012 Estimated Study Completion Date:Jan 2016
Intervention Details Description:
*Drug: Interleukin-2 Dose will vary depending upon when participant enters the trial: Given as a daily injection under the skin for 8 weeks.
Detailed Description:
- Patients receive low dose interleukin-2(Daily 1×106 IU per square meter of body-surface area) on days 60 after unmanipulated blood and marrow transplantation. Interleukin-2 treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- Participants will be seen periodically while they are receiving IL-2. Physical exams and blood tests will be performed weekly for the first two weeks and then every other week until the completion of 6 course therapy.
Eligibility Ages Eligible for Study:15 Years and older Genders Eligible for Study:Both Accepts Healthy Volunteers:No Criteria
Inclusion Criteria:
- Standard risk of Recipients of allogeneic stem cell transplantation with myeloablative conditioning regimens
- Standard risk of Recipients: CR1 or CR 2 of AML/ALL before transplantation
- Ph+ ALL，AML with t(8;21) and T-ALL were excepted
- Patients were at least 60 days post-transplantation
- Bone marrow monitoring was still Complete Remission (CR) and minor residual disease (MRD) was negative
- 15 years of age or older
- No serious infection
Exclusion Criteria:
- Exposure to any other clinical trials prior to enrollment
- Active malignant disease relapse
- Active, uncontrolled infection
- Inability to comply with IL-2 treatment regimen
- Conditions
- Leukemia
- Being tested
- Interleukin-2
- Keywords
- IL2, relapse, GVHD, survival, allogeneic stem cell transplantation, MRD, CR
- Medical subject headings
- Leukemia, Recurrence
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
Patients receive low dose interleukin-2(Daily 1×106 IU per square meter of body-surface area) on days 60 after unmanipulated blood and marrow transplantation. Interleukin-2 treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Interleukin-2 | Experimental | Interleukin-2 post-transplantation to prevent relapse of standard risk leukemia Receives: Drug: Interleukin-2 |
| controlled group | No intervention | controlled standard risk leukemia received regular transplantation without IL-2 intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility and efficiency of administering 6 courses of subcutaneous IL-2 in these patients population.
investigate the incidences of severe GVHD and pancytopenia after IL-2 application to evaluate the safety of this drug.
observe the drug toxicity based on common toxicity criteria (CTC,version 3.0). compare the relapse rate and incidence of positive MRD between two groups to evaluate the efficiency of IL-2 application.
Measured: 2 years
Secondary outcomes (1)
To assess the immunologic impact of ultra-low dose subcutaneous IL-2 in patients after transplantation
examine the immune reconstitution of subgroups of T cells after IL-2 application and compare with that of controlled group of patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Because the conditional power was 0.083, the Data and Safety Monitoring Board recommended halting the study due to futility after the 1st interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Huang, Peking University People's Hospital
- Investigators
- Xiaojun Huang, MD, Principal investigator, Peking University Institute of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517347
- Sponsor's protocol ID
- PUPH IRB [2012] (09）
- Status last verified
- Oct 2016
- First submitted
- 10 Jan 2012
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose of Interleukin-2 Following Allogeneic Unmanipulated Blood and Marrow Transplantation in Treating Patients With Standard Risk Hematologic Malignancy
- ClinicalTrials.gov ID
- NCT01517347
- Acronym / sponsor ID
- PUPH IRB [2012] (09）
- Conditions
- Leukemia
- Keywords
- IL2, relapse, GVHD, survival, allogeneic stem cell transplantation, MRD, CR
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because the conditional power was 0.083, the Data and Safety Monitoring Board recommended halting the study due to futility after the 1st interim analysis.
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Jan 2012 (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.
Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, relapse rate was still the key question to influence the overall survival after transplantation, even in standard risk leukemia.There were good evidences that natural killer cells and T regulatory cells, which were expanded and stimulated by the application of IL-2, could mediate protection against GvHD while maintaining graft anti-tumor activity as a positive side effect. Meanwhile, it was found in our previous pilot study that low-dose IL-2 subcutaneous administration from 100 days for a prolonged period could be a safe and effective strategy to prevent relapse in acute lymphoblastic malignancy patients with high risk of recurrence after unmanipulated allo-HSCT.
The study hypothesis:
Prevention of relapse using low dose IL-2 following hematopoietic stem cell transplantation in patients with standard risk acute leukemia can
- reduce relapse rate
- improve survival
Detailed description
Standard risk patients over 15 years old(except Ph+ ALL, AML t(8;21) and T-ALL) undergone unmanipulated blood and marrow transplantation following day 60 post-transplantation were randomized into treated group (with low dose IL-2 treatment) or controlled group (without any intervention post-transplantation). The end points were safety and clinical and immunologic response.Following time is 24 months.
Primary Outcome Measures:
*To determine the feasibility and efficacy of administering an 6 course of subcutaneous IL-2 in this patient population. [ Time Frame: 2 years ]
Secondary Outcome Measures:
*To assess the immunologic impact of ultra-low dose subcutaneous IL-2 in patients after transplantation [ Time Frame: 2 years ] Estimated Enrollment:360 Study Start Date:Jan 2012 Estimated Study Completion Date:Jan 2016
Intervention Details Description:
*Drug: Interleukin-2 Dose will vary depending upon when participant enters the trial: Given as a daily injection under the skin for 8 weeks.
Detailed Description:
- Patients receive low dose interleukin-2(Daily 1×106 IU per square meter of body-surface area) on days 60 after unmanipulated blood and marrow transplantation. Interleukin-2 treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- Participants will be seen periodically while they are receiving IL-2. Physical exams and blood tests will be performed weekly for the first two weeks and then every other week until the completion of 6 course therapy.
Eligibility Ages Eligible for Study:15 Years and older Genders Eligible for Study:Both Accepts Healthy Volunteers:No Criteria
Inclusion Criteria:
- Standard risk of Recipients of allogeneic stem cell transplantation with myeloablative conditioning regimens
- Standard risk of Recipients: CR1 or CR 2 of AML/ALL before transplantation
- Ph+ ALL，AML with t(8;21) and T-ALL were excepted
- Patients were at least 60 days post-transplantation
- Bone marrow monitoring was still Complete Remission (CR) and minor residual disease (MRD) was negative
- 15 years of age or older
- No serious infection
Exclusion Criteria:
- Exposure to any other clinical trials prior to enrollment
- Active malignant disease relapse
- Active, uncontrolled infection
- Inability to comply with IL-2 treatment regimen
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interleukin-2 | Experimental | Drug: Interleukin-2Interleukin-2 post-transplantation to prevent relapse of standard risk leukemia |
| controlled group | No intervention | –controlled standard risk leukemia received regular transplantation without IL-2 intervention |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Standard risk of Recipients (CR1 or CR 2 of AML/ALL before transplantation except Ph+ ALL and T-ALL) of allogeneic stem cell transplantation with myeloablative conditioning regimens
- Standard risk of Recipients: CR1 or CR 2 of AML/ALL before transplantation
- Ph+ ALL, AML with t(8;21) and T-ALL were excepted
- Patients were at least 60 days post-transplantation
- Bone marrow monitoring was still Complete Remission (CR) and minor residual disease (MRD) was negative
Key exclusion criteria (4 listed)
- Exposure to any other clinical trials prior to enrollment
- Active malignant disease relapse
- Active, uncontrolled infection
- Inability to comply with IL-2 treatment regimen
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-2Patients receive low dose interleukin-2(Daily 1×106 IU per square meter of body-surface area) on days 60 after unmanipulated blood and marrow transplantation. Interleukin-2 treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. | Drug | Interleukin-2 |
Primary outcome
To determine the feasibility and efficiency of administering 6 courses of subcutaneous IL-2 in these patients population.
Time frame: 2 years
investigate the incidences of severe GVHD and pancytopenia after IL-2 application to evaluate the safety of this drug. observe the drug toxicity based on common toxicity criteria (CTC,version 3.0). compare the relapse rate and incidence of positive MRD between two groups to evaluate the efficiency of IL-2 application.
1 secondary outcome
To assess the immunologic impact of ultra-low dose subcutaneous IL-2 in patients after transplantation
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Because the conditional power was 0.083, the Data and Safety Monitoring Board recommended halting the study due to futility after the 1st interim analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
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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, MD principal investigator
Peking University Institute of Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interleukin-2 in people with Leukemia, 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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 24 Oct 2016. 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.
Are results available for this study?
The study was stopped early (reason given: Because the conditional power was 0.083, the Data and Safety Monitoring Board recommended halting the study due to futility after the 1st interim analysis.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the feasibility and efficiency of administering 6 courses of subcutaneous IL-2 in these patients population. (time frame: 2 years). 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 24 Oct 2016.