A RANDOMIZED PHASE 2/3 TRIAL OF SCH 54031 PEG12000 INTERFERON ALFA-2b (PEG INTRON, SCH 54031) VS. INTRON A (SCH 30500) IN SUBJECTS WITH NEWLY DIAGNOSED CML (PROTOCOL NOS. C/I98-026)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 344
- 主要终点
- Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months
研究概览
简要总结
The primary purpose of this study is to compare the efficacy of polyethylene glycol (PEG; pegylated) interferon alfa-2b (PEG Intron, C98026) versus interferon alfa-2b (Intron® A) in the treatment of participants with newly diagnosed CML.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Has accelerated phase CML as defined by any of the following criteria.
- •peripheral blood myeloblasts >/=15%
- •peripheral blood basophils >/= 20%
- •peripheral blood myeloblasts plus promyelocytes >/=30%
- •platelets <100,000/microl, unrelated to therapy
- •Has blastic phase CML (30% myeloblasts in peripheral blood or bone marrow)
- •Is a candidate for and is planning to receive allogeneic, syngeneic, or autologous bone marrow transplantation within the next 12 months
- •Has received prior treatment for their CML, except for hydroxyurea (collection of stem cells without using high dose chemotherapy for mobilization is acceptable)
- •Has severe cardiovascular disease (i. e., arrhythmias requiring chronic treatment, congestive heart failure [New York Heart Association (NYHA) Class III or IV], or symptomatic ischemic heart disease)
- •Has a history of a neuropsychiatric disorder requiring hospitalization
- •Has thyroid dysfunction not responsive to therapy
- •Has uncontrolled diabetes mellitus
- •Has a history of seropositivity for human immunodeficiency virus
- •Has active and/or uncontrolled infection, including active hepatitis
- •Has a medical condition requiring chronic systemic corticosteroids
- •Has a history of prior malignancies within the last 5 years, except for surgically cured non-melanoma skin cancer, or cervical carcinoma in situ
- •Has received any experimental therapy within 30 days prior to enrollment in this study
- •Is known to be actively abusing alcohol or drugs
- •Is pregnant, nursing, or of reproductive potential and is not practicing an effective means of contraception
研究组 & 干预措施
Pegylated interferon alfa-2b
Participants received pegylated interferon alfa-2b (PEG Intron) at a dose of 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Participants may have received hydroxyurea therapy as needed prior to randomization to reduce or keep the white blood cell (WBC) count ≤50,000/μl. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
干预措施: Pegylated interferon alfa-2b (Biological)
Interferon alfa-2b
Participants received interferon alfa-2b (Intron^® A), recombinant for injection, at a dose of 5 million international units (MIU)/m^2, administered daily by SC injection. Participants may have received hydroxyurea therapy as needed prior to randomization to reduce or keep the WBC count ≤50,000/μl. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
干预措施: Interferon alfa-2b (Biological)
结局指标
主要结局
Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months
时间窗: Up to 12 months
Cytogenetic response (CR) was defined by the degree of suppression of Philadelphia chromosome (Ph\^1) achieved during study treatment. For all participants continuing treatment after study conclusion, cytogenetic assessments were conducted locally as per standard of care. Determination of CR at 12 months were based on cytogenetic analysis of bone marrow aspirate samples. The CR criteria were based on the percentage (%) of PH\^1-positive cells during study treatment. Protocol-defined CR criteria were Complete Response (0%), Partial Response (1-34%), Minor Response (35-90%), or No Response (\>90%). Data for the analysis population was based on the intent-to-treat principle. Participants who were treatment failures at 6 months were considered cytogenetic non-responders. Recording of CR was independent of hematologic responses.
次要结局
- Number of Participants With Cytogenetic Response (CR) to PEG Intron and Intron A at 6 Months(6 months)
- Number of Participants With Hematologic Responses to PEG Intron and Intron A at 6 Months(6 months)
- Number of Participants With Overall Survival(Up to 2 years (24 months), and beyond)