Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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

Condition Intervention
Leukemia
Drug: Interleukin-2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Low Dose of Interleukin-2 Following Allogeneic Unmanipulated Blood and Marrow Transplantation in Treating Patients With Standard Risk Hematologic Malignancy

Resource links provided by NLM:


Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 360
Study Start Date: January 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interleukin-2
Interleukin-2 post-transplantation to prevent relapse of standard risk 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
No Intervention: controlled group
controlled standard risk leukemia received regular transplantation without IL-2 intervention

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
  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517347

Contacts
Contact: Xiaosu Zhao, PhD and MD +861088324577 zhao.xiaosu@gmail.com
Contact: Xiangyu Zhao, PHD and MD +861088324671 zhao_xy@bjmu.edu.cn

Locations
China, Beijing
Xiaosu Zhao Recruiting
Beijing, Beijing, China, 100044
Contact: Xiaosu Zhao, PhD and MD    +861088324577    zhao.xiaosu@gmail.com   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
Principal Investigator: Xiaojun Huang, MD Peking University Institute of Hematology
  More Information

No publications provided

Responsible Party: Xiaojun Huang, Chief of Peking University Institute of Hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01517347     History of Changes
Other Study ID Numbers: PUPH IRB [2012] (09)
Study First Received: January 10, 2012
Last Updated: June 7, 2014
Health Authority: China: Ministry of Health

Keywords provided by Peking University People's Hospital:
IL2
relapse
GVHD
survival
allogeneic stem cell transplantation
MRD
CR

Additional relevant MeSH terms:
Leukemia
Neoplasms
Neoplasms by Histologic Type
Interleukin-2
Analgesics
Analgesics, Non-Narcotic
Antineoplastic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014