Efficiency Study of Low Dose of IL-2 to Prevent Relapse in Standard Risk Leukemia After Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Peking University People's Hospital
Sponsor:
Information provided by (Responsible Party):
Xiaojun Huang, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01517347
First received: January 10, 2012
Last updated: June 7, 2014
Last verified: June 2014

January 10, 2012
June 7, 2014
January 2012
January 2015   (final data collection date for 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 ] [ Designated as safety issue: Yes ]

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.

To determine the feasibility and efficiency of administering 6 courses of subcutaneous IL-2 in these patients population. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01517347 on ClinicalTrials.gov Archive Site
To assess the immunologic impact of ultra-low dose subcutaneous IL-2 in patients after transplantation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
examine the immune reconstitution of subgroups of T cells after IL-2 application and compare with that of controlled group of patients.
To assess the immunologic impact of ultra-low dose subcutaneous IL-2 in patients after transpantation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficiency Study of Low Dose of IL-2 to Prevent Relapse in Standard Risk Leukemia After Transplantation
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:

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

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Leukemia
Drug: Interleukin-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.
Other Name: IL-2
  • Experimental: Interleukin-2
    Interleukin-2 post-transplantation to prevent relapse of standard risk leukemia
    Intervention: Drug: Interleukin-2
  • No Intervention: controlled group
    controlled standard risk leukemia received regular transplantation without IL-2 intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
January 2017
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

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
Both
15 Years to 65 Years
No
Contact: Xiaosu Zhao, PhD and MD +861088324577 zhao.xiaosu@gmail.com
Contact: Xiangyu Zhao, PHD and MD +861088324671 zhao_xy@bjmu.edu.cn
China
 
NCT01517347
PUPH IRB [2012] (09)
Yes
Xiaojun Huang, Peking University People's Hospital
Peking University People's Hospital
Not Provided
Principal Investigator: Xiaojun Huang, MD Peking University Institute of Hematology
Peking University People's Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP