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CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

2014年3月21日更新者：National Cancer Institute (NCI)

A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma

This phase II trial is studying how well giving CCI-779 together with rituximab works in treating patients with relapsed or refractory mantle cell lymphoma. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving CCI-779 together with rituximab may kill more cancer cells

研究概览

地位

完全的

条件

复发性套细胞淋巴瘤

干预/治疗

详细说明

PRIMARY OBJECTIVES:

I. Determine the overall response rate in patients with relapsed or refractory mantle cell lymphoma treated with CCI-779 and rituximab.

II. Determine the tolerability of this regimen in these patients by assessing toxicity.

SECONDARY OBJECTIVES:

I. Determine the time to disease progression and overall survival of patients treated with this regimen.

II. Determine the duration of response in patients treated with this regimen.

OUTLINE: Patients are stratified according to prior response to rituximab (sensitive [partial response (PR) or complete response (CR) that lasted ≥ 6 months after the last treatment with rituximab alone or in combination with chemotherapy] vs refractory [stable or progressive disease OR a PR or CR that lasted < 6 months after the last treatment with rituximab alone or in combination with chemotherapy]).

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.

研究类型

介入性

注册 (实际的)

阶段

阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Alabama
  - Mobile、Alabama、美国、36607
    - Mobile Infirmary Medical Center
- Colorado
  - Aurora、Colorado、美国、80012
    - The Medical Center of Aurora
  - Boulder、Colorado、美国、80301
    - Boulder Community Hospital
  - Colorado Springs、Colorado、美国、80907
    - Penrose-Saint Francis Healthcare
  - Denver、Colorado、美国、80210
    - Porter Adventist Hospital
  - Denver、Colorado、美国、80218
    - Presbyterian - Saint Lukes Medical Center - Health One
  - Denver、Colorado、美国、80220
    - Rose Medical Center
  - Denver、Colorado、美国、80218
    - Exempla Saint Joseph Hospital
  - Denver、Colorado、美国、80224-2522
    - Colorado Cancer Research Program CCOP
  - Denver、Colorado、美国、80204
    - Saint Anthony Central Hospital
  - Englewood、Colorado、美国、80110
    - Swedish Medical Center
  - Grand Junction、Colorado、美国、81502
    - Saint Mary's Hospital and Regional Medical Center
  - Greeley、Colorado、美国、80631
    - North Colorado Medical Center
  - Lone Tree、Colorado、美国、80124
    - Sky Ridge Medical Center
  - Longmont、Colorado、美国、80501
    - Longmont United Hospital
  - Loveland、Colorado、美国、80539
    - McKee Medical Center
  - Pueblo、Colorado、美国、81004
    - Saint Mary Corwin Medical Center
  - Thornton、Colorado、美国、80229
    - North Suburban Medical Center
  - Wheat Ridge、Colorado、美国、80033
    - Exempla Lutheran Medical Center
- Illinois
  - Aurora、Illinois、美国、60504
    - Rush - Copley Medical Center
  - Bloomington、Illinois、美国、61701
    - Saint Joseph Medical Center
  - Canton、Illinois、美国、61520
    - Graham Hospital Association
  - Carthage、Illinois、美国、62321
    - Memorial Hospital
  - Eureka、Illinois、美国、61530
    - Eureka Hospital
  - Galesburg、Illinois、美国、61401
    - Galesburg Cottage Hospital
  - Galesburg、Illinois、美国、61401
    - Galesburg Clinic
  - Havana、Illinois、美国、62644
    - Mason District Hospital
  - Hopedale、Illinois、美国、61747
    - Hopedale Medical Complex - Hospital
  - Joliet、Illinois、美国、60435
    - Joliet Oncology-Hematology Associates Limited
  - Kewanee、Illinois、美国、61443
    - Kewanee Hospital
  - Macomb、Illinois、美国、61455
    - Mcdonough District Hospital
  - Normal、Illinois、美国、61761
    - Community Cancer Center Foundation
  - Normal、Illinois、美国、61761
    - Bromenn Regional Medical Center
  - Ottawa、Illinois、美国、61350
    - Illinois CancerCare-Ottawa Clinic
  - Ottawa、Illinois、美国、61350
    - Ottawa Regional Hospital and Healthcare Center
  - Pekin、Illinois、美国、61554
    - Pekin Cancer Treatment Center
  - Pekin、Illinois、美国、61554
    - Pekin Hospital
  - Peoria、Illinois、美国、61637
    - OSF Saint Francis Medical Center
  - Peoria、Illinois、美国、61615
    - Illinois CancerCare-Peoria
  - Peoria、Illinois、美国、61614
    - Proctor Hospital
  - Peoria、Illinois、美国、61603
    - Methodist Medical Center of Illinois
  - Peoria、Illinois、美国、61615
    - Illinois Oncology Research Association CCOP
  - Peru、Illinois、美国、61354
    - Illinois Valley Hospital
  - Princeton、Illinois、美国、61356
    - Perry Memorial Hospital
  - Spring Valley、Illinois、美国、61362
    - Saint Margaret's Hospital
  - Urbana、Illinois、美国、61801
    - Carle Clinic-Urbana Main
  - Urbana、Illinois、美国、61801
    - Carle Foundation dba Carle Cancer Center
- Indiana
  - Beech Grove、Indiana、美国、46107
    - Saint Francis Hospital and Health Centers
  - Michigan City、Indiana、美国、46360
    - Saint Anthony Memorial Health Center
  - Richmond、Indiana、美国、47374
    - Reid Hospital and Health Care Services
- Iowa
  - Ames、Iowa、美国、50010
    - McFarland Clinic
  - Cedar Rapids、Iowa、美国、52403
    - Mercy Hospital
  - Cedar Rapids、Iowa、美国、52402
    - Saint Luke's Hospital
  - Cedar Rapids、Iowa、美国、52403
    - Cedar Rapids Oncology Association
  - Cedar Rapids、Iowa、美国、52403
    - Oncology Associates
  - Clive、Iowa、美国、50325
    - Medical Oncology and Hematology Associates-West Des Moines
  - Des Moines、Iowa、美国、50309
    - Iowa Methodist Medical Center
  - Des Moines、Iowa、美国、50314
    - Mercy Medical Center - Des Moines
  - Des Moines、Iowa、美国、50309
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines、Iowa、美国、50316
    - Iowa Lutheran Hospital
  - Des Moines、Iowa、美国、50307
    - Mercy Capitol
  - Des Moines、Iowa、美国、50309
    - Iowa Oncology Research Association CCOP
  - Des Moines、Iowa、美国、50314
    - Medical Oncology and Hematology Associates
  - Mason City、Iowa、美国、50401
    - Mercy Medical Center - North Iowa
  - Sioux City、Iowa、美国、51104
    - Saint Luke's Regional Medical Center
  - Sioux City、Iowa、美国、51101-1733
    - Siouxland Regional Cancer Center
  - Sioux City、Iowa、美国、51104
    - Mercy Medical Center-Sioux City
  - Sioux City、Iowa、美国、51101
    - Siouxland Hematology - Oncology Associates
- Kansas
  - Anthony、Kansas、美国、67003
    - Hospital District Sixth of Harper County
  - Chanute、Kansas、美国、66720
    - Cancer Center of Kansas - Chanute
  - Dodge City、Kansas、美国、67801
    - Cancer Center of Kansas - Dodge City
  - El Dorado、Kansas、美国、67042
    - Cancer Center of Kansas - El Dorado
  - Fort Scott、Kansas、美国、66701
    - Cancer Center of Kansas - Fort Scott
  - Independence、Kansas、美国、67301
    - Cancer Center of Kansas-Independence
  - Kingman、Kansas、美国、67068
    - Cancer Center of Kansas-Kingman
  - Lawrence、Kansas、美国、66044
    - Lawrence Memorial Hospital
  - Newton、Kansas、美国、67114
    - Cancer Center of Kansas - Newton
  - Parsons、Kansas、美国、67357
    - Cancer Center of Kansas - Parsons
  - Pratt、Kansas、美国、67124
    - Cancer Center of Kansas - Pratt
  - Salina、Kansas、美国、67401
    - Cancer Center of Kansas - Salina
  - Wellington、Kansas、美国、67152
    - Cancer Center of Kansas - Wellington
  - Wichita、Kansas、美国、67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita、Kansas、美国、67208
    - Associates In Womens Health
  - Wichita、Kansas、美国、67214
    - Cancer Center of Kansas - Main Office
  - Wichita、Kansas、美国、67214
    - Via Christi Regional Medical Center
  - Wichita、Kansas、美国、67214
    - Wichita CCOP
  - Winfield、Kansas、美国、67156
    - Cancer Center of Kansas - Winfield
- Michigan
  - Adrian、Michigan、美国、49221
    - Bixby Medical Center
  - Adrian、Michigan、美国、49221
    - Hickman Cancer Center
  - Ann Arbor、Michigan、美国、48106-0995
    - Saint Joseph Mercy Hospital
  - Ann Arbor、Michigan、美国、48106
    - Michigan Cancer Research Consortium Community Clinical Oncology Program
  - Dearborn、Michigan、美国、48123
    - Oakwood Hospital
  - Detroit、Michigan、美国、48236
    - Saint John Hospital and Medical Center
  - Flint、Michigan、美国、48502
    - Hurley Medical Center
  - Flint、Michigan、美国、48532
    - Genesys Regional Medical Center
  - Jackson、Michigan、美国、49201
    - Allegiance Health
  - Lansing、Michigan、美国、48912
    - Sparrow Hospital
  - Livonia、Michigan、美国、48154
    - Saint Mary Mercy Hospital
  - Monroe、Michigan、美国、48162
    - Mercy Memorial Hospital
  - Monroe、Michigan、美国、48162
    - Community Cancer Center of Monroe
  - Pontiac、Michigan、美国、48341-2985
    - Saint Joseph Mercy Oakland
  - Port Huron、Michigan、美国、48060
    - Saint Joseph Mercy Port Huron
  - Saginaw、Michigan、美国、48601
    - Saint Mary's of Michigan
  - Warren、Michigan、美国、48093
    - Saint John Macomb-Oakland Hospital
- Minnesota
  - Bemidji、Minnesota、美国、56601
    - Merit Care Clinic Bemidji
  - Burnsville、Minnesota、美国、55337
    - Fairview Ridges Hospital
  - Coon Rapids、Minnesota、美国、55433
    - Mercy Hospital
  - Duluth、Minnesota、美国、55805
    - Miller-Dwan Hospital
  - Duluth、Minnesota、美国、55805
    - Saint Mary's Medical Center
  - Duluth、Minnesota、美国、55805
    - Duluth Clinic CCOP
  - Edina、Minnesota、美国、55435
    - Fairview-Southdale Hospital
  - Fridley、Minnesota、美国、55432
    - Unity Hospital
  - Maplewood、Minnesota、美国、55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis、Minnesota、美国、55407
    - Abbott-Northwestern Hospital
  - Robbinsdale、Minnesota、美国、55422
    - North Memorial Medical Health Center
  - Rochester、Minnesota、美国、55905
    - Mayo Clinic
  - Saint Louis Park、Minnesota、美国、55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Louis Park、Minnesota、美国、55416
    - Metro-Minnesota CCOP
  - Saint Paul、Minnesota、美国、55102
    - United Hospital
  - Shakopee、Minnesota、美国、55379
    - Saint Francis Regional Medical Center
  - Waconia、Minnesota、美国、55387
    - Ridgeview Medical Center
  - Woodbury、Minnesota、美国、55125
    - Minnesota Oncology and Hematology PA-Woodbury
- Montana
  - Billings、Montana、美国、59101
    - Saint Vincent Healthcare
  - Billings、Montana、美国、59101
    - Northern Rockies Radiation Oncology Center
  - Billings、Montana、美国、59101
    - Montana Cancer Consortium CCOP
  - Billings、Montana、美国、59107-7000
    - Billings Clinic
  - Billings、Montana、美国、59107
    - Deaconess Medical Center
  - Billings、Montana、美国、59101
    - Hematology-Oncology Centers of the Northern Rockies PC
  - Bozeman、Montana、美国、59715
    - Bozeman Deaconess Hospital
  - Bozeman、Montana、美国、59715
    - Bozeman Deaconess Cancer Center
  - Butte、Montana、美国、59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls、Montana、美国、59405
    - Great Falls Clinic
  - Great Falls、Montana、美国、59405
    - Berdeaux, Donald MD (UIA Investigator)
  - Havre、Montana、美国、59501
    - Northern Montana Hospital
  - Helena、Montana、美国、59601
    - Saint Peter's Community Hospital
  - Kalispell、Montana、美国、59901
    - Kalispell Regional Medical Center
  - Kalispell、Montana、美国、59901
    - Glacier Oncology PLLC
  - Kalispell、Montana、美国、59901
    - Kalispell Medical Oncology
  - Missoula、Montana、美国、59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula、Montana、美国、59804
    - Guardian Oncology and Center for Wellness
  - Missoula、Montana、美国、59801
    - Community Medical Hospital
  - Missoula、Montana、美国、59802
    - Montana Cancer Specialists
- North Carolina
  - Rutherfordton、North Carolina、美国、28139
    - Rutherford Hospital
- North Dakota
  - Bismarck、North Dakota、美国、58501
    - Bismarck Cancer Center
  - Bismarck、North Dakota、美国、58501
    - Mid Dakota Clinic
  - Bismarck、North Dakota、美国、58501
    - Saint Alexius Medical Center
  - Bismarck、North Dakota、美国、58501
    - Medcenter One Health Systems
  - Fargo、North Dakota、美国、58122
    - MeritCare Medical Group
  - Fargo、North Dakota、美国、58122
    - Meritcare Hospital
- Ohio
  - Bowling Green、Ohio、美国、43402
    - Wood County Oncology Center
  - Dayton、Ohio、美国、45406
    - Good Samaritan Hospital - Dayton
  - Dayton、Ohio、美国、45409
    - Miami Valley Hospital
  - Dayton、Ohio、美国、45415
    - Samaritan North Health Center
  - Dayton、Ohio、美国、45405
    - Grandview Hospital
  - Dayton、Ohio、美国、45428
    - Veteran Affairs Medical Center
  - Dayton、Ohio、美国、45429
    - Dayton CCOP
  - Elyria、Ohio、美国、44035
    - Hematology Oncology Center Incorporated
  - Findlay、Ohio、美国、45840
    - Blanchard Valley Hospital
  - Franklin、Ohio、美国、45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Fremont、Ohio、美国、43420
    - Fremont Memorial Hospital
  - Greenville、Ohio、美国、45331
    - Wayne Hospital
  - Kenton、Ohio、美国、43326
    - Cole, Sharon, K. M.D. (UIA Investigator)
  - Kettering、Ohio、美国、45429
    - Kettering Medical Center
  - Lima、Ohio、美国、45804
    - Lima Memorial Hospital
  - Maumee、Ohio、美国、43537
    - Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
  - Maumee、Ohio、美国、43537-1839
    - Northwest Ohio Oncology Center
  - Maumee、Ohio、美国、43537
    - Saint Luke's Hospital
  - Oregon、Ohio、美国、43616
    - Saint Charles Hospital
  - Oregon、Ohio、美国、43616
    - Bayview Oncology Associates
  - Sandusky、Ohio、美国、44870
    - North Coast Cancer Care
  - Sandusky、Ohio、美国、44870
    - Firelands Regional Medical Center
  - Sylvania、Ohio、美国、43560
    - Flower Memorial Hospital
  - Tiffin、Ohio、美国、44883
    - Mercy Hospital of Tiffin
  - Toledo、Ohio、美国、43608
    - Saint Vincent Mercy Medical Center
  - Toledo、Ohio、美国、43614
    - University of Toledo
  - Toledo、Ohio、美国、43617
    - Toledo Community Hospital Oncology Program CCOP
  - Toledo、Ohio、美国、43606
    - The Toledo Hospital
  - Toledo、Ohio、美国、43623
    - Toledo Clinic
  - Toledo、Ohio、美国、43623
    - Stark, Michael, Edward. M.D. (UIA Investigator)
  - Toledo、Ohio、美国、43623
    - Mercy Cancer Center at Saint Anne Mercy Hospital
  - Troy、Ohio、美国、45373
    - Upper Valley Medical Center
  - Wauseon、Ohio、美国、43567
    - Fulton County Health Center
  - Wilmington、Ohio、美国、45177
    - Clinton Memorial Hospital
  - Xenia、Ohio、美国、45385
    - Greene Memorial Hospital
- Pennsylvania
  - Allentown、Pennsylvania、美国、18105
    - Lehigh Valley Hospital
  - Danville、Pennsylvania、美国、17822-2001
    - Geisinger Medical Center
  - State College、Pennsylvania、美国、16801
    - Geisinger Medical Group
  - Wilkes-Barre、Pennsylvania、美国、18711
    - Geisinger Wyoming Valley
- South Carolina
  - Anderson、South Carolina、美国、29621
    - AnMed Health Hospital
  - Spartanburg、South Carolina、美国、29303
    - Spartanburg Regional Medical Center
  - Spartanburg、South Carolina、美国、29303
    - Upstate Carolina CCOP
- South Dakota
  - Sioux Falls、South Dakota、美国、57105
    - Avera Cancer Institute
  - Sioux Falls、South Dakota、美国、57105
    - Avera McKennan Hospital and University Health Center
- Virginia
  - Fredericksburg、Virginia、美国、22401
    - Fredericksburg Oncology Inc
- Wyoming
  - Sheridan、Wyoming、美国、82801
    - Welch Cancer Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Histologically confirmed* mantle cell lymphoma (MCL)
- Relapsed, refractory, or stable disease after prior treatment
- Tumor must be cyclin D-1 by immunohistochemistry OR 11;14 translocation by fluorescent in situ hybridization or cytogenetics
Measurable disease, defined as ≥ 1 of the following:
- Unidimensionally measurable lymph node or tumor mass ≥ 2 cm by CT scan or MRI
- Splenic enlargement if spleen is palpable ≥ 3 cm below the left costal margin
- Malignant lymphocytosis if absolute lymphocytic count ≥ 5,000 AND lymphocytes confirmed to be monoclonal by flow cytometry
No known central nervous system involvement (e.g., parenchymal mass or leptomeningeal involvement)
Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
At least 3 months
No other concurrent treatment for MCL
Absolute neutrophil count ≥ 1,000/mm^3
Platelet count ≥ 75,000/mm^3
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
Direct bilirubin < 1.5 times ULN
Aspartate aminotransferase (AST) ≤ 3 times ULN (5 times ULN if liver involvement by MCL is present)
Creatinine ≤ 2 times ULN
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
Cholesterol ≤ 350 mg/dL
Fasting triglycerides < 400 mg/dL
No known HIV positivity
No ongoing or active infection
No psychiatric illness or social situation that would preclude study compliance
No other uncontrolled illness
No other active malignancy requiring treatment OR that would preclude assessment of response to study drugs
Prior biologic response modifiers allowed
Prior immunotherapy allowed
Prior high-dose therapy with stem cell support (i.e., stem cell transplantation) allowed
No concurrent prophylactic growth factor to support neutrophils
Prior chemotherapy allowed
No other concurrent chemotherapy
No concurrent corticosteroids to induce an antitumor response
- Concurrent corticosteroids (≤ 10 mg/day of prednisone or equivalent) for adrenal insufficiency or acute allergic reactions allowed
Prior radiotherapy allowed
No prior treatment with a mammalian target of rapamycin (mTOR) inhibitor
No other concurrent investigational or commercial agents or therapies for MCL
No other concurrent immunosuppressive therapy

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：不适用
介入模型：单组作业
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Arm I Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.	生物：rituximab 375 mg/m^2 Given IV 其他名称：利妥昔单抗马布泰拉 IDEC-C2B8 IDEC-C2B8单克隆抗体摩押IDEC-C2B8 药品：temsirolimus 25 mg given IV 其他名称：托利塞尔 CCI-779 细胞周期抑制剂779

参与者组/臂

干预/治疗

实验性的：Arm I

生物：rituximab

375 mg/m^2 Given IV

其他名称：

利妥昔单抗
马布泰拉
IDEC-C2B8
IDEC-C2B8单克隆抗体
摩押IDEC-C2B8

药品：temsirolimus

25 mg given IV

其他名称：

托利塞尔
CCI-779
细胞周期抑制剂779

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria 大体时间：Up to 12, 28-day cycles.	Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. Partial Response (PR) requires a >=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses. Overall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients. We report the Overall Response Rate here.	Up to 12, 28-day cycles.

次要结果测量

结果测量	措施说明	大体时间
Time to Progression 大体时间：Patients were followed up to five years after registration.	Time to progression was defined as the time from registration to the date of progression. Patients who died without disease progression were censored at the date of their last evaluation. Patients who were still receiving treatment at the time of these analyses were censored at the date of their last evaluation. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.	Patients were followed up to five years after registration.
Duration of Response 大体时间：Response duration is followed up to 5 years from registration.	Duration of response was defined as the time from the date of documented response to the date of progression. Patients who went off treatment due to other reasons (eg, adverse reactions, refusal of further treatment) were censored at that time. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.	Response duration is followed up to 5 years from registration.
Toxicity 大体时间：Assessed during treatment (up to 12, 28-day cycles)	As per the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3, toxicity was defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment by the treating physician. In this section, we report the number of participants that experienced at least one Grade 3 or higher adverse event.	Assessed during treatment (up to 12, 28-day cycles)
Overall Survival 大体时间：Patients were followed for survival status for up to 5 years.	Overall survival (OS) was defined as the time from registration to death resulting from any cause. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.	Patients were followed for survival status for up to 5 years.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Cancer Institute (NCI)

调查人员

首席研究员：Stephen Ansell、North Central Cancer Treatment Group

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Ansell SM, Tang H, Kurtin PJ, Koenig PA, Inwards DJ, Shah K, Ziesmer SC, Feldman AL, Rao R, Gupta M, Erlichman C, Witzig TE. Temsirolimus and rituximab in patients with relapsed or refractory mantle cell lymphoma: a phase 2 study. Lancet Oncol. 2011 Apr;12(4):361-8. doi: 10.1016/S1470-2045(11)70062-6.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年5月1日

初级完成 (实际的)

2009年9月1日

研究完成 (实际的)

2012年3月1日

研究注册日期

首次提交

2005年5月3日

首先提交符合 QC 标准的

2005年5月3日

首次发布 (估计)

2005年5月4日

研究记录更新

最后更新发布 (估计)

2014年4月17日

上次提交的符合 QC 标准的更新

2014年3月21日

最后验证

2013年12月1日

rituximab的临床试验

Aprea Therapeutics

终止

APR-246 联合基于 Acalabrutinib 或 Venetoclax 的疗法治疗 R/R 非霍奇金淋巴瘤 (NHL) 患者 (R/R)

套细胞淋巴瘤 | 慢性淋巴细胞白血病 | 非霍奇金淋巴瘤

美国
Laida Cuevas Palomares

招聘中

非霍奇金淋巴瘤中的超快 Truxima 输注：Txagorapid 研究

非霍奇金淋巴瘤

西班牙
Zhengzhou University

尚未招聘

泽布替尼、利妥昔单抗和来那度胺在边缘区淋巴瘤一线治疗中的应用

边缘区淋巴瘤(MZL)
Peng Liu

招聘中

ZPR 方案治疗复发/难治性弥漫性大 B 细胞淋巴瘤的前瞻性临床研究

弥漫性大 B 细胞淋巴瘤

中国
Assiut University

未知

儿童难治性癫痫饮食和免疫管理的比较研究

难治性癫痫
Johns Hopkins University
Patient-Centered Outcomes Research Institute; National Multiple Sclerosis Society

主动，不招人

多发性硬化症试验的传统与早期积极治疗 (TREAT-MS)

多发性硬化症，复发缓解

美国
Tongji Hospital
First Affiliated Hospital of Fujian Medical University; The General Hospital of Western Theater... 和其他合作者

招聘中

一项关于甲氨蝶呤、利妥昔单抗、信迪利单抗和吡托布鲁替尼治疗初治原发性中枢神经系统淋巴瘤（PCNSL）与真实世界研究者选择治疗（观察性队列）的多中心双队列研究 (PRIME-PCNSL)

原发性中枢神经系统淋巴瘤 | PCNSL

中国
Ruijin Hospital

招聘中

4R-CHOP+4R 与 6R-CHOP+2R 治疗新诊断低危 DLBCL 患者的安全性和有效性

弥漫性大 B 细胞淋巴瘤

中国
Memorial Sloan Kettering Cancer Center

完全的

利妥昔单抗、甲氨蝶呤、丙卡巴肼和长春新碱联合大剂量化疗联合自体干细胞拯救新诊断原发性中枢神经系统淋巴瘤 (PCNSL)

非霍奇金淋巴瘤 | 中枢神经系统淋巴瘤 | 中枢神经系统脑癌

美国

CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma

研究概览

地位

条件

干预/治疗

详细说明

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

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

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

出版物和有用的链接

一般刊物

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 (估计)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

rituximab的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Tunisia

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点