interferon α for the therapy of minimal residual disease

Conditions: Leukemia

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.

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 1. severe toxicity occurrence 2. cumulative incidence of relapse increased) (≥ 30%) 3. cumulative incidence of mortality increased (≥ 30%) 4. cumulative incidence of severe graft-versus-host disease increased (≥ 30%) 5. although large enough sample had been enrolled, it did not reach statistical significance

Eligibility criteria:
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

Keywords: relapse minimal residual disease graft-versus-host disease acute leukemia interferon alfa-2b