Clinical Trial: Interferon α for the Therapy of Minimal Residual Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Interferon α for the Therapy of Minimal Residual Disease Following Hematopoietic Stem Cell Transplantation

Brief Summary:

This study aimed to evaluate the efficacy of interferon α among patients undergone unmanipulated blood and marrow transplantation following day 60 post-transplantation who were minimal residual disease positive after transplantation.

Hematopoietic stem cell transplantation (HSCT) is an effective treatment option for acute leukemia and many other hematological malignancies. However, post-transplant relapse can occur in some patients, and the prognosis of these patients is usually very poor.The persistence or recurrence of minimal residual disease (MRD) in the post-transplant period is an independent risk factor of relapse. Therefore, MRD monitoring can be used to screen patients with a high risk of relapse to provide timely intervention and prevent post-transplant relapse.Interferon α-2b exerts a relatively strong immunomodulatory effect. It can kill acute leukemia (AL) cells by regulating T-cell and/or natural killer cell functions.Consequently, interferon α-2b may have potential therapeutic value for AL patients with MRD-positive after transplantation.

The study hypothesis:

Prevention of relapse using interferon α-2b following hematopoietic stem cell transplantation in patients with standard risk acute leukemia can reduce relapse rate.


Detailed Summary:

Standard risk acute leukemia patients (except t(9;22)(q34; q11), t(15;17), inv(16)(p13q22), t(16;16)(p13; q22), or t(8;21)(q22; q22) cytogenetic abnormalities.) undergone unmanipulated blood and marrow transplantation following day 60 post-transplantation who were minimal residual disease positive after hematopoietic stem cell transplantation received interferon α-2b. The end points were safety and immunologic response. Following time is 12 months.

Primary Outcome Measures:

*The feasibility and efficacy of administering of subcutaneous interferon α-2b in this patient population. [ Time Frame: 1 years ]

Secondary Outcome Measures:

*The immunologic impact and clinical outcomes of subcutaneous interferon α-2b in patients after unmanipulated blood and marrow transplantation [ Time Frame: 1 years ] Estimated Enrollment:81 Study Start Date: Jun 2014 Estimated Study Completion Date: Jun 2016

Intervention Details Description:

*Drug:Interferon α-2b (subcutaneously at dosages of 3 million units 2-3 times per week) for 6 months in the absence of disease progression or unacceptable toxicity.

Acute leukemia patients who were MRD positive after day 60 post-transplantation receive interferon α-2b(subcutaneously at dosages of 3 million units 2-3 times per week). Interferon α-2b continues for 6 months in the absence of disease progression or unacceptable toxicity.

Participants will be seen periodically while they are receiving interferon α-2b. Physical exams and blood tests will be performed weekly for the firs
Sponsor: Peking University People's Hospital

Current Primary Outcome: relapse rate [ Time Frame: participants will be followed for an expected average of 1 year ]

number of participants with morphologic relapse at one year


Original Primary Outcome: Same as current

Current Secondary Outcome: The immunologic impact of subcutaneous interferon α-2b [ Time Frame: participants will be followed for an expected average of 1 year ]

examine the immune reconstitution of subgroups of T cells and nature killer cells after interferon α-2b application


Original Secondary Outcome: Same as current

Information By: Peking University People's Hospital

Dates:
Date Received: February 10, 2014
Date Started: June 2014
Date Completion: June 2018
Last Updated: July 6, 2014
Last Verified: July 2014