EUCTR2005-004630-41-GR进行中（未招募）不适用
A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin - PRELUDE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 459
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •[1] have had a histologically confirmed diagnosis of DLBCL by the World
- •Health Organization classification (Harris et al. 1999) at the time of
- •original diagnosis. Pathology must be reviewed and confirmed prior
- •to enrollment at the investigational site where the patient is entered.
- •Patients may be entered and randomized based on local pathology;
- •however, an independent centralized pathology review will be
- •performed on all enrolled patients (see Section 6.4.1). Commonly
- •accepted histological variants of DLBCL, such as immunoblastic
- •lymphoma, primary mediastinal B-cell lymphoma, and T-cell rich Bcell
- •lymphoma are allowed.
- •[2] if any gallium scan was performed, the most recent gallium scan must
- •be negative. However, gallium scans are not a required study
- •[3] if any PET scan was performed, the most recent PET scan must be
- •negative, as judged by local radiologist and/or physician (an
- •independent centralized radiology review will also be performed on
- •these patients). Exceptions may be made (after consultation with the
- •Lilly clinical research physician) for patients with PET-positive lesions
- •in which a subsequent confirmation procedure (for instance, biopsy)
- •reveals the lesion is not due to DLBCL. However, PET scans are not a
- •required study procedure. (See Section 6.1.1 for more information.)
- •[4] have completed six to eight 21-day cycles of R-CHOP, or six to eight
- •14-day cycles of R-CHOP as first-line therapy for DLBCL. (Refer to
- •Section 5.5 for recommended regimens.) The patient must have
- •achieved a CR or CRu (and have not subsequently progressed)
- •according to International Workshop criteria (Cheson et al. 1999), or
- •must be PET scan negative (according to Juweid et al. 2007), as
- •judged by local radiologist and/or physician (an independent
- •centralized radiology review will also be performed on these patients).
- •Exceptions may be made (after consultation with the Lilly clinical
- •research physician) for patients with PET-positive lesions in which a
- •subsequent confirmation procedure (for instance, biopsy) reveals the
- •lesion is not due to DLBCL.
- •[5] have an IPI score =3 at time of original diagnosis (refer to Protocol
- •Attachment JCBJ.4).
- •[6] have had Stage 3 or 4 disease, or have had Stage 2 with bulky disease
- •(defined as =10 cm), at time of original diagnosis.
- •[7] have given informed consent.
- •[8] have an estimated life expectancy of at least 12 weeks.
- •[9] have a performance status of 0, 1, or 2 on the Eastern Cooperative
- •Oncology Group (ECOG) scale (see Protocol Attachment JCBJ.7;
- •Oken et al. 1982).
- •[10] exhibit patient compliance and geographic proximity that allow for
- •adequate follow-up.
- •[11] have adequate organ function as follows:
- •Hepatic: total bilirubin =1.5 times upper limit of normal (ULN);
- •alanine transaminase (ALT) and aspartate transaminase (AST)
- •=2.5 times ULN
- •Renal: serum creatinine <1.5 times ULN
- •Adequate bone marrow reserve: platelets =50 x 109/L, absolute
- •neutrophil count (ANC) =1.0 x 109/L, hemoglobin =8 g/dL.
- 另有 9 项未显示
排除标准
- •[15] have received treatment within the last 30 days with a drug that has not
- •received regulatory approval for any indication at the time of study
- •[16] receive concurrent administration of any other systemic anticancer
- •therapy. Patients who had been receiving chronic therapy such as
- •hormonal therapy (for example, tamoxifen), low-dose (7.5 mg/week)
- •methotrexate, or corticosteroids prior to the diagnosis and treatment of
- •DLBCL, may continue to receive these therapies while on study, after
- •agreement with the Lilly clinical research physician; however,
- •initiation of these medications while the patient is on study is not
- •allowed. Intrathecal prophylaxis is allowed.
- •[17] have received radiation therapy to more than one targeted lesion (local
- •residual disease) for treatment of lymphoma or have not recovered
- •from the acute effects of radiation therapy prior to study entry.
- •[18] are pregnant or breastfeeding.
- •[19] have central nervous system (CNS) metastases (unless the patient has
- •completed successful local therapy for CNS metastases and has been
- •off of corticosteroids for at least 4 weeks before starting study
- •therapy). In the absence of a clinical suspicion of brain metastases, no
- •screening computed tomography (CT) or magnetic resonance imaging
- •(MRI) scan before enrollment is required.
- •[20] have serious concomitant disorder, including active bacterial, fungal,
- •or viral infection, incompatible with the study (at the discretion of the
- •investigator).
- •[21] are known to be HIV positive.
- •[22] have a second primary malignancy (except adequately treated nonmelanomatous
- •skin cancer, or other cancer that is considered cured by
- •surgical resection or radiation). Patients who had another malignancy
- •in the past, but have been disease-free for more than 5 years, are
- •[23] have a serious cardiac condition, such as myocardial infarction within
- •6 months, angina, or heart disease, as defined by the New York Heart
- •Association Class III or IV (see Protocol Attachment JCBJ.5).
- •[24] are unable to swallow tablets.
- •[25] requires use of carbamazepine, phenobarbital, or phenytoin (refer to
- •Section 5.7).
- •[26] prior stem cell or bone marrow transplantation.
- •[27] a prior clinical history of an indolent lymphoma.
研究者
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