ISRCTN59346371已完成3 期
A phase III, prospective randomised comparison of imatinib (STI571, Glivec/Gleevec) 400 mg daily versus imatinib 800 mg daily versus imatinib plus PEG interferon-alpha 2a (Pegasys) in patients with newly-diagnosed chronic phasechronic myeloid leukaemia
ewcastle upon Tyne Hospitals Trust (UK)0 个研究点目标入组 2,466 人开始时间: 2001年5月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,466
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female patients 18years or older
- •2. Patients must have all of the following:
- •a. Be enrolled within three months of initial diagnosis of CML-CP (date of initial diagnosis is the date of first cytogenetic analysis)
- •b. Be previously untreated for CML with the exception of hydroxyurea and/or anagrelide
- •c. Cytogenetic confirmation of the Philadelphia chromosome or variants of (9;22) translocations, patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome
- •d. Less than 15% blasts in peripheral blood and bone marrow
- •e. Less than 30% blasts plus promyelocytes in peripheral blood and bone marrow
- •f. Less than 20% basophils in peripheral blood
- •g. More than or equal to 100 x 10^9 l platelets
- •h. No evidence of extramedullary leukaemic involvement, with the exception of the hepatosplenomegaly
- •3. Written voluntary informed consent
排除标准
- •1. Patients with Ph-negative, BCR-ABL-positive, disease are NOT eligible for the study
- •2. Any prior treatment for CML with busulphan, interferon-alpha, imatinib, homoharringtonine, cytosine arabinoside, or any other investigational agents (hydroxyurea and anagrelide are the only drugs permitted)
- •N.B. patients will be ineligible for SPIRIT if they have received ANY prior therapy with interferon-alpha or imatinib. NO exceptions
- •3. Patients who received prior chemotherapy, including regimens used in Peripheral Blood Progenitor Cells (PBPCs) mobilization for haematopoietic progenitor-cell transplantation. It is allowable to collect unmobilized PBPCs at diagnosis
- •4. Patients who have had any form of prior haemopoietic stem cell transplant, eitherautograft or allograft
- •5. Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status Score more than or equal to three
- •6. Patients with serum bilirubin, Serum Glutamic Oxaloacetic Transaminase (SGOT)/aspartate aminotransferase (AST), Serum Glutamic Pyruvic Transaminase (SGPT)/alanine aminotransferase (ALT), or creatinine concentrations more than 2.0 x the Institutional Upper Limit of the Normal range (IULN)
- •7. Patients with International Normalised Ratio (INR) or Partial Thromboplastin Time (PTT) more than 1.5 x IULN, with the exception of patients on treatment with oralanticoagulants
- •8. Patients with uncontrolled medical disease such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders, infection, angina, or Grade three/four cardiac problems as defined by the New York Heart Association Criteria
- •9. Patients with a prior history of significant psychiatric illness, particularly depression
- •10. Patients with known positivity for Human Immunodeficiency Virus (HIV); baseline testing for HIV is not required
- •11. Patients who have undergone major surgery within four weeks of Study Day one, or who have not recovered from prior major surgery
- •12. Patients who are:
- •a. Pregnant
- •b. Breast feeding
- •c. Of childbearing potential without a negative pregnancy test prior to Study Day one
- •d. Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential)
- •13. Patients with a history of another malignancy either currently or within the past five years, with the exception of basal cell skin carcinoma or cervical carcinoma in situ
- •14. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable
研究者
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