Ignite Creation Date:
2024-05-06 @ 12:11 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01517347
Status:
TERMINATED
Last Update Posted:
2016-10-24
First Post:
2012-01-10
Brief Title:
Efficiency Study of Low Dose of IL-2 to Prevent Relapse in Standard Risk Leukemia After Transplantation
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Low Dose of Interleukin-2 Following Allogeneic Unmanipulated Blood and Marrow Transplantation in Treating Patients With Standard Risk Hematologic Malignancy
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Because the conditional power was 0083 the Data and Safety Monitoring Board recommended halting the study due to futility after the 1st interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 leukemiaThere 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
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 oldexcept Ph ALL AML t821 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 responseFollowing 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 Enrollment360 Study Start DateJan 2012 Estimated Study Completion DateJan 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-2Daily 1106 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 Study15 Years and older Genders Eligible for StudyBoth Accepts Healthy VolunteersNo 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 AMLALL before transplantation
Ph ALLAML with t821 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
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 Enrollment360 Study Start DateJan 2012 Estimated Study Completion DateJan 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-2Daily 1106 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 Study15 Years and older Genders Eligible for StudyBoth Accepts Healthy VolunteersNo 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 AMLALL before transplantation
Ph ALLAML with t821 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None