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

NCT01517347 | Terminated DMC

• 1 other identifier: PUPH IRB [2012] (09）
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 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

Conditions

Leukemia

Keywords

IL2; relapse; GVHD; survival; allogeneic stem cell transplantation; MRD; CR

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• To assess the immunologic impact of ultra-low dose subcutaneous IL-2 in patients after transplantation

  2 years

Study Arms (2)

Interleukin-2

EXPERIMENTAL

Interleukin-2 post-transplantation to prevent relapse of standard risk leukemia

Drug: Interleukin-2

controlled group

NO INTERVENTION

controlled standard risk leukemia received regular transplantation without IL-2 intervention

Interventions

Interleukin-2 DRUG

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.

Also known as: IL-2

Interleukin-2

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• No serious infection

You may not qualify if:

• Exposure to any other clinical trials prior to enrollment
• Active malignant disease relapse
• Active, uncontrolled infection
• Inability to comply with IL-2 treatment regimen

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Xiaosu Zhao

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Leukemia; Recurrence

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Xiaojun Huang, MD

  Peking University Institute of Hematology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Peking University Institute of Hematology

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 25, 2012
• Study Start: January 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 24, 2016

Record last verified: 2016-10

Locations

CN (1)