Interferon α for the Therapy of Minimal Residual Disease

Study Overview
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Brief Summary
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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 Description
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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 first two weeks and then every other week until the completion of 6 months therapy. Eligibility Ages Eligible for Study: 1-60 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria The trial will be terminated in following situation Severe toxicity occurrence Cumulative incidence of relapse increased) (≥ 30%) Cumulative incidence of mortality increased (≥ 30%) Cumulative incidence of severe graft-versus-host disease increased (≥ 30%) Although large enough sample had been enrolled, it did not reach statistical significance

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

Conditions
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Leukemia

Intervention / Treatment
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* Drug: Interferon Alfa-2b


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had standard-risk acute myeloid leukemia(CR1 or CR2) had minimal residual disease positive after hematopoietic stem cell transplantation Exclusion Criteria: Patients with t(9;22)(q34; q11), t(15;17), inv(16)(p13q22), t(16;16)(p13; q22), or t(8;21)(q22; q22) cytogenetic abnormalities;active graft-versus-host disease; active infection; organ failure; exposure to donor lymphocyte infusion prior to enrollment

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interferon Alfa-2b group<br>Acute leukemia patients who are minimal residual disease positive after hematopoietic stem cell transplantation receive interferon Alfa-2b | Drug: Interferon Alfa-2b<br>* Patients who were deemed MRD-positive after day 60 post-transplantation receive interferon α-2b (subcutaneously at dosages of 3 million units 2-3 times per week) . Interferon treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.<br>* Other names: INF α-2b;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate | number of participants with morphologic relapse at one year | participants will be followed for an expected average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The immunologic impact of subcutaneous interferon α-2b | examine the immune reconstitution of subgroups of T cells and nature killer cells after interferon α-2b application | participants will be followed for an expected average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapse, Minimal residual disease, Graft-versus-host disease, Acute leukemia, Interferon Alfa-2b