Trial Information

Low Dose of Interleukin-2 Following Allogeneic Unmanipulated Blood and Marrow Transplantation in Treating Patients With Standard Risk Hematologic Malignancy

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