IMPACT Non Hodgkins Lymphoma (NHL) Study
A Retrospective and Prospective Observational Study Reviewing Supportive Care Management of NHL Patients Treated With CHOP-14 or 21 Chemotherapy(With or Without Rituximab) (CHOP = Cyclophosphamide, Hydroxyrubicin (Adriamycin), Oncovin (Vincristine), Prednisone Chemotherapy )
研究概览
详细说明
This is a multi-center, international observational study of subjects receiving CHOP-14 or CHOP-21 (with or without Rituximab) for the treatment of NHL. Approximately 100-150 sites will contribute information on subjects treated at their institution.
To avoid geographical bias, sites will be selected to represent the spread of subjects in each country. Each site will be initially limited to 5 retrospective subjects and 10 prospective subjects (15 subjects per site) but sites may be asked to contribute further subjects to approximately 10 retrospective subjects and 20 prospective subjects.
Retrospective subjects may include any subject that has completed all cycles of chemotherapy treatment prior to date of site initiation. Prospective subjects which may be considered for the study are any subject planned for CHOP-14 or CHOP-21 (with or without Rituximab) treatment after the site initiation visit.
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Subjects greater than or equal to 18 years old
- Subjects diagnosed with any histological type of NHL (including both chemotherapy naïve and pre-treated subjects)
- Subjects planned to receive a minimum of 3 cycles of CHOP-14 or CHOP-21 with or without Rituximab (for subjects enrolled retrospectively, eligibility should be assessed on the profile at time of planning treatment, where treatment initiates on or after 01 Jan 2005, with specific focus on planned chemotherapy and not outcome or number of delivered cycles)
- Before any study-specific procedure, the appropriate written informed consent must be obtained for countries where this is required
Exclusion Criteria:
- Subjects receiving CHOEP ((CHOP = Cytoxan, Hydroxyrubicin (Adriamycin), Oncovin (Vincristine),Etoposide, Prednisone Chemotherapy )or CNOP (Cytoxan, Novantrone, Oncovin (Vincristine),Etoposide, Prednisone) chemotherapy are not eligible for inclusion in this study
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
A
No intervention - observational study
|
No intervention as observational study
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Proportion of subjects who had an investigator assessed risk of FN ≥20% and received primary prophylaxis G-CSF
大体时间:At the end of observational period (when all subjects completed planned chemotherapy or stopped treatment)
|
At the end of observational period (when all subjects completed planned chemotherapy or stopped treatment)
|
合作者和调查者
赞助
出版物和有用的链接
一般刊物
- Haioun C, Salar A, Pettengell R, Johnsen HE, Duehrsen U, Rossi FG, Verhoef G, Schwenkglenks M, Jaeger U, Hamilton L, Pujol B, Lugtenburg PJ. Anemia and erythropoiesis-stimulating agent administration in patients with non-Hodgkin lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisolone +/- rituximab chemotherapy: results from an observational study. Leuk Lymphoma. 2011 May;52(5):796-803. doi: 10.3109/10428194.2011.557166. Epub 2011 Feb 21.
- Lugtenburg P, Silvestre AS, Rossi FG, Noens L, Krall W, Bendall K, Szabo Z, Jaeger U. Impact of age group on febrile neutropenia risk assessment and management in patients with diffuse large B-cell lymphoma treated with R-CHOP regimens. Clin Lymphoma Myeloma Leuk. 2012 Oct;12(5):297-305. doi: 10.1016/j.clml.2012.06.004.
- Pettengell R, Johnsen HE, Lugtenburg PJ, Silvestre AS, Duhrsen U, Rossi FG, Schwenkglenks M, Bendall K, Szabo Z, Jaeger U. Impact of febrile neutropenia on R-CHOP chemotherapy delivery and hospitalizations among patients with diffuse large B-cell lymphoma. Support Care Cancer. 2012 Mar;20(3):647-52. doi: 10.1007/s00520-011-1306-6. Epub 2011 Nov 20. Erratum In: Support Care Cancer. 2013 Feb;21(2):653. Johnson, Hans E [corrected to Johnsen, Hans E].
- Weycker D, Danel A, Marciniak A, Bendall K, Lipsitz M, Pettengell R. Economic costs of chemotherapy-induced febrile neutropenia among patients with non-Hodgkin's lymphoma in European and Australian clinical practice. BMC Cancer. 2012 Aug 22;12:362. doi: 10.1186/1471-2407-12-362.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
非霍奇金淋巴瘤的临床试验
-
Rutgers, The State University of New Jersey完全的
No intervention的临床试验
-
University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人
-
University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人
-
Otsuka Pharmaceutical Factory, Inc.Celerion完全的