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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Alabama
-
Mobile、Alabama、アメリカ、36607
- Mobile Infirmary Medical Center
-
-
Colorado
-
Aurora、Colorado、アメリカ、80012
- The Medical Center of Aurora
-
Boulder、Colorado、アメリカ、80301
- Boulder Community Hospital
-
Colorado Springs、Colorado、アメリカ、80907
- Penrose-Saint Francis Healthcare
-
Denver、Colorado、アメリカ、80210
- Porter Adventist Hospital
-
Denver、Colorado、アメリカ、80218
- Presbyterian - Saint Lukes Medical Center - Health One
-
Denver、Colorado、アメリカ、80220
- Rose Medical Center
-
Denver、Colorado、アメリカ、80218
- Exempla Saint Joseph Hospital
-
Denver、Colorado、アメリカ、80224-2522
- Colorado Cancer Research Program CCOP
-
Denver、Colorado、アメリカ、80204
- Saint Anthony Central Hospital
-
Englewood、Colorado、アメリカ、80110
- Swedish Medical Center
-
Grand Junction、Colorado、アメリカ、81502
- Saint Mary's Hospital and Regional Medical Center
-
Greeley、Colorado、アメリカ、80631
- North Colorado Medical Center
-
Lone Tree、Colorado、アメリカ、80124
- Sky Ridge Medical Center
-
Longmont、Colorado、アメリカ、80501
- Longmont United Hospital
-
Loveland、Colorado、アメリカ、80539
- McKee Medical Center
-
Pueblo、Colorado、アメリカ、81004
- Saint Mary Corwin Medical Center
-
Thornton、Colorado、アメリカ、80229
- North Suburban Medical Center
-
Wheat Ridge、Colorado、アメリカ、80033
- Exempla Lutheran Medical Center
-
-
Illinois
-
Aurora、Illinois、アメリカ、60504
- Rush - Copley Medical Center
-
Bloomington、Illinois、アメリカ、61701
- Saint Joseph Medical Center
-
Canton、Illinois、アメリカ、61520
- Graham Hospital Association
-
Carthage、Illinois、アメリカ、62321
- Memorial Hospital
-
Eureka、Illinois、アメリカ、61530
- Eureka Hospital
-
Galesburg、Illinois、アメリカ、61401
- Galesburg Cottage Hospital
-
Galesburg、Illinois、アメリカ、61401
- Galesburg Clinic
-
Havana、Illinois、アメリカ、62644
- Mason District Hospital
-
Hopedale、Illinois、アメリカ、61747
- Hopedale Medical Complex - Hospital
-
Joliet、Illinois、アメリカ、60435
- Joliet Oncology-Hematology Associates Limited
-
Kewanee、Illinois、アメリカ、61443
- Kewanee Hospital
-
Macomb、Illinois、アメリカ、61455
- Mcdonough District Hospital
-
Normal、Illinois、アメリカ、61761
- Community Cancer Center Foundation
-
Normal、Illinois、アメリカ、61761
- Bromenn Regional Medical Center
-
Ottawa、Illinois、アメリカ、61350
- Illinois CancerCare-Ottawa Clinic
-
Ottawa、Illinois、アメリカ、61350
- Ottawa Regional Hospital and Healthcare Center
-
Pekin、Illinois、アメリカ、61554
- Pekin Cancer Treatment Center
-
Pekin、Illinois、アメリカ、61554
- Pekin Hospital
-
Peoria、Illinois、アメリカ、61637
- OSF Saint Francis Medical Center
-
Peoria、Illinois、アメリカ、61615
- Illinois CancerCare-Peoria
-
Peoria、Illinois、アメリカ、61614
- Proctor Hospital
-
Peoria、Illinois、アメリカ、61603
- Methodist Medical Center of Illinois
-
Peoria、Illinois、アメリカ、61615
- Illinois Oncology Research Association CCOP
-
Peru、Illinois、アメリカ、61354
- Illinois Valley Hospital
-
Princeton、Illinois、アメリカ、61356
- Perry Memorial Hospital
-
Spring Valley、Illinois、アメリカ、61362
- Saint Margaret's Hospital
-
Urbana、Illinois、アメリカ、61801
- Carle Clinic-Urbana Main
-
Urbana、Illinois、アメリカ、61801
- Carle Foundation dba Carle Cancer Center
-
-
Indiana
-
Beech Grove、Indiana、アメリカ、46107
- Saint Francis Hospital and Health Centers
-
Michigan City、Indiana、アメリカ、46360
- Saint Anthony Memorial Health Center
-
Richmond、Indiana、アメリカ、47374
- Reid Hospital and Health Care Services
-
-
Iowa
-
Ames、Iowa、アメリカ、50010
- McFarland Clinic
-
Cedar Rapids、Iowa、アメリカ、52403
- Mercy Hospital
-
Cedar Rapids、Iowa、アメリカ、52402
- Saint Luke's Hospital
-
Cedar Rapids、Iowa、アメリカ、52403
- Cedar Rapids Oncology Association
-
Cedar Rapids、Iowa、アメリカ、52403
- Oncology Associates
-
Clive、Iowa、アメリカ、50325
- Medical Oncology and Hematology Associates-West Des Moines
-
Des Moines、Iowa、アメリカ、50309
- Iowa Methodist Medical Center
-
Des Moines、Iowa、アメリカ、50314
- Mercy Medical Center - Des Moines
-
Des Moines、Iowa、アメリカ、50309
- Medical Oncology and Hematology Associates-Des Moines
-
Des Moines、Iowa、アメリカ、50316
- Iowa Lutheran Hospital
-
Des Moines、Iowa、アメリカ、50307
- Mercy Capitol
-
Des Moines、Iowa、アメリカ、50309
- Iowa Oncology Research Association CCOP
-
Des Moines、Iowa、アメリカ、50314
- Medical Oncology and Hematology Associates
-
Mason City、Iowa、アメリカ、50401
- Mercy Medical Center - North Iowa
-
Sioux City、Iowa、アメリカ、51104
- Saint Luke's Regional Medical Center
-
Sioux City、Iowa、アメリカ、51101-1733
- Siouxland Regional Cancer Center
-
Sioux City、Iowa、アメリカ、51104
- Mercy Medical Center-Sioux City
-
Sioux City、Iowa、アメリカ、51101
- Siouxland Hematology - Oncology Associates
-
-
Kansas
-
Anthony、Kansas、アメリカ、67003
- Hospital District Sixth of Harper County
-
Chanute、Kansas、アメリカ、66720
- Cancer Center of Kansas - Chanute
-
Dodge City、Kansas、アメリカ、67801
- Cancer Center of Kansas - Dodge City
-
El Dorado、Kansas、アメリカ、67042
- Cancer Center of Kansas - El Dorado
-
Fort Scott、Kansas、アメリカ、66701
- Cancer Center of Kansas - Fort Scott
-
Independence、Kansas、アメリカ、67301
- Cancer Center of Kansas-Independence
-
Kingman、Kansas、アメリカ、67068
- Cancer Center of Kansas-Kingman
-
Lawrence、Kansas、アメリカ、66044
- Lawrence Memorial Hospital
-
Newton、Kansas、アメリカ、67114
- Cancer Center of Kansas - Newton
-
Parsons、Kansas、アメリカ、67357
- Cancer Center of Kansas - Parsons
-
Pratt、Kansas、アメリカ、67124
- Cancer Center of Kansas - Pratt
-
Salina、Kansas、アメリカ、67401
- Cancer Center of Kansas - Salina
-
Wellington、Kansas、アメリカ、67152
- Cancer Center of Kansas - Wellington
-
Wichita、Kansas、アメリカ、67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
-
Wichita、Kansas、アメリカ、67208
- Associates In Womens Health
-
Wichita、Kansas、アメリカ、67214
- Cancer Center of Kansas - Main Office
-
Wichita、Kansas、アメリカ、67214
- Via Christi Regional Medical Center
-
Wichita、Kansas、アメリカ、67214
- Wichita CCOP
-
Winfield、Kansas、アメリカ、67156
- Cancer Center of Kansas - Winfield
-
-
Michigan
-
Adrian、Michigan、アメリカ、49221
- Bixby Medical Center
-
Adrian、Michigan、アメリカ、49221
- Hickman Cancer Center
-
Ann Arbor、Michigan、アメリカ、48106-0995
- Saint Joseph Mercy Hospital
-
Ann Arbor、Michigan、アメリカ、48106
- Michigan Cancer Research Consortium Community Clinical Oncology Program
-
Dearborn、Michigan、アメリカ、48123
- Oakwood Hospital
-
Detroit、Michigan、アメリカ、48236
- Saint John Hospital and Medical Center
-
Flint、Michigan、アメリカ、48502
- Hurley Medical Center
-
Flint、Michigan、アメリカ、48532
- Genesys Regional Medical Center
-
Jackson、Michigan、アメリカ、49201
- Allegiance Health
-
Lansing、Michigan、アメリカ、48912
- Sparrow Hospital
-
Livonia、Michigan、アメリカ、48154
- Saint Mary Mercy Hospital
-
Monroe、Michigan、アメリカ、48162
- Mercy Memorial Hospital
-
Monroe、Michigan、アメリカ、48162
- Community Cancer Center of Monroe
-
Pontiac、Michigan、アメリカ、48341-2985
- Saint Joseph Mercy Oakland
-
Port Huron、Michigan、アメリカ、48060
- Saint Joseph Mercy Port Huron
-
Saginaw、Michigan、アメリカ、48601
- Saint Mary's of Michigan
-
Warren、Michigan、アメリカ、48093
- Saint John Macomb-Oakland Hospital
-
-
Minnesota
-
Bemidji、Minnesota、アメリカ、56601
- Merit Care Clinic Bemidji
-
Burnsville、Minnesota、アメリカ、55337
- Fairview Ridges Hospital
-
Coon Rapids、Minnesota、アメリカ、55433
- Mercy Hospital
-
Duluth、Minnesota、アメリカ、55805
- Miller-Dwan Hospital
-
Duluth、Minnesota、アメリカ、55805
- Saint Mary's Medical Center
-
Duluth、Minnesota、アメリカ、55805
- Duluth Clinic CCOP
-
Edina、Minnesota、アメリカ、55435
- Fairview-Southdale Hospital
-
Fridley、Minnesota、アメリカ、55432
- Unity Hospital
-
Maplewood、Minnesota、アメリカ、55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis、Minnesota、アメリカ、55407
- Abbott-Northwestern Hospital
-
Robbinsdale、Minnesota、アメリカ、55422
- North Memorial Medical Health Center
-
Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
-
Saint Louis Park、Minnesota、アメリカ、55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Louis Park、Minnesota、アメリカ、55416
- Metro-Minnesota CCOP
-
Saint Paul、Minnesota、アメリカ、55102
- United Hospital
-
Shakopee、Minnesota、アメリカ、55379
- Saint Francis Regional Medical Center
-
Waconia、Minnesota、アメリカ、55387
- Ridgeview Medical Center
-
Woodbury、Minnesota、アメリカ、55125
- Minnesota Oncology and Hematology PA-Woodbury
-
-
Montana
-
Billings、Montana、アメリカ、59101
- Saint Vincent Healthcare
-
Billings、Montana、アメリカ、59101
- Northern Rockies Radiation Oncology Center
-
Billings、Montana、アメリカ、59101
- Montana Cancer Consortium CCOP
-
Billings、Montana、アメリカ、59107-7000
- Billings Clinic
-
Billings、Montana、アメリカ、59107
- Deaconess Medical Center
-
Billings、Montana、アメリカ、59101
- Hematology-Oncology Centers of the Northern Rockies PC
-
Bozeman、Montana、アメリカ、59715
- Bozeman Deaconess Hospital
-
Bozeman、Montana、アメリカ、59715
- Bozeman Deaconess Cancer Center
-
Butte、Montana、アメリカ、59701
- Saint James Community Hospital and Cancer Treatment Center
-
Great Falls、Montana、アメリカ、59405
- Great Falls Clinic
-
Great Falls、Montana、アメリカ、59405
- Berdeaux, Donald MD (UIA Investigator)
-
Havre、Montana、アメリカ、59501
- Northern Montana Hospital
-
Helena、Montana、アメリカ、59601
- Saint Peter's Community Hospital
-
Kalispell、Montana、アメリカ、59901
- Kalispell Regional Medical Center
-
Kalispell、Montana、アメリカ、59901
- Glacier Oncology PLLC
-
Kalispell、Montana、アメリカ、59901
- Kalispell Medical Oncology
-
Missoula、Montana、アメリカ、59802
- Saint Patrick Hospital - Community Hospital
-
Missoula、Montana、アメリカ、59804
- Guardian Oncology and Center for Wellness
-
Missoula、Montana、アメリカ、59801
- Community Medical Hospital
-
Missoula、Montana、アメリカ、59802
- Montana Cancer Specialists
-
-
North Carolina
-
Rutherfordton、North Carolina、アメリカ、28139
- Rutherford Hospital
-
-
North Dakota
-
Bismarck、North Dakota、アメリカ、58501
- Bismarck Cancer Center
-
Bismarck、North Dakota、アメリカ、58501
- Mid Dakota Clinic
-
Bismarck、North Dakota、アメリカ、58501
- Saint Alexius Medical Center
-
Bismarck、North Dakota、アメリカ、58501
- Medcenter One Health Systems
-
Fargo、North Dakota、アメリカ、58122
- MeritCare Medical Group
-
Fargo、North Dakota、アメリカ、58122
- Meritcare Hospital
-
-
Ohio
-
Bowling Green、Ohio、アメリカ、43402
- Wood County Oncology Center
-
Dayton、Ohio、アメリカ、45406
- Good Samaritan Hospital - Dayton
-
Dayton、Ohio、アメリカ、45409
- Miami Valley Hospital
-
Dayton、Ohio、アメリカ、45415
- Samaritan North Health Center
-
Dayton、Ohio、アメリカ、45405
- Grandview Hospital
-
Dayton、Ohio、アメリカ、45428
- Veteran Affairs Medical Center
-
Dayton、Ohio、アメリカ、45429
- Dayton CCOP
-
Elyria、Ohio、アメリカ、44035
- Hematology Oncology Center Incorporated
-
Findlay、Ohio、アメリカ、45840
- Blanchard Valley Hospital
-
Franklin、Ohio、アメリカ、45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Fremont、Ohio、アメリカ、43420
- Fremont Memorial Hospital
-
Greenville、Ohio、アメリカ、45331
- Wayne Hospital
-
Kenton、Ohio、アメリカ、43326
- Cole, Sharon, K. M.D. (UIA Investigator)
-
Kettering、Ohio、アメリカ、45429
- Kettering Medical Center
-
Lima、Ohio、アメリカ、45804
- Lima Memorial Hospital
-
Maumee、Ohio、アメリカ、43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
-
Maumee、Ohio、アメリカ、43537-1839
- Northwest Ohio Oncology Center
-
Maumee、Ohio、アメリカ、43537
- Saint Luke's Hospital
-
Oregon、Ohio、アメリカ、43616
- Saint Charles Hospital
-
Oregon、Ohio、アメリカ、43616
- Bayview Oncology Associates
-
Sandusky、Ohio、アメリカ、44870
- North Coast Cancer Care
-
Sandusky、Ohio、アメリカ、44870
- Firelands Regional Medical Center
-
Sylvania、Ohio、アメリカ、43560
- Flower Memorial Hospital
-
Tiffin、Ohio、アメリカ、44883
- Mercy Hospital of Tiffin
-
Toledo、Ohio、アメリカ、43608
- Saint Vincent Mercy Medical Center
-
Toledo、Ohio、アメリカ、43614
- University of Toledo
-
Toledo、Ohio、アメリカ、43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo、Ohio、アメリカ、43606
- The Toledo Hospital
-
Toledo、Ohio、アメリカ、43623
- Toledo Clinic
-
Toledo、Ohio、アメリカ、43623
- Stark, Michael, Edward. M.D. (UIA Investigator)
-
Toledo、Ohio、アメリカ、43623
- Mercy Cancer Center at Saint Anne Mercy Hospital
-
Troy、Ohio、アメリカ、45373
- Upper Valley Medical Center
-
Wauseon、Ohio、アメリカ、43567
- Fulton County Health Center
-
Wilmington、Ohio、アメリカ、45177
- Clinton Memorial Hospital
-
Xenia、Ohio、アメリカ、45385
- Greene Memorial Hospital
-
-
Pennsylvania
-
Allentown、Pennsylvania、アメリカ、18105
- LeHigh Valley Hospital
-
Danville、Pennsylvania、アメリカ、17822-2001
- Geisinger Medical Center
-
State College、Pennsylvania、アメリカ、16801
- Geisinger Medical Group
-
Wilkes-Barre、Pennsylvania、アメリカ、18711
- Geisinger Wyoming Valley
-
-
South Carolina
-
Anderson、South Carolina、アメリカ、29621
- AnMed Health Hospital
-
Spartanburg、South Carolina、アメリカ、29303
- Spartanburg Regional Medical Center
-
Spartanburg、South Carolina、アメリカ、29303
- Upstate Carolina CCOP
-
-
South Dakota
-
Sioux Falls、South Dakota、アメリカ、57105
- Avera Cancer Institute
-
Sioux Falls、South Dakota、アメリカ、57105
- Avera McKennan Hospital and University Health Center
-
-
Virginia
-
Fredericksburg、Virginia、アメリカ、22401
- Fredericksburg Oncology Inc
-
-
Wyoming
-
Sheridan、Wyoming、アメリカ、82801
- Welch Cancer Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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.
|
375 mg/m^2 Given IV
他の名前:
25 mg given IV
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria
時間枠: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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Time to Progression
時間枠: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
時間枠: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
時間枠: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
時間枠: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.
|
協力者と研究者
捜査官
- 主任研究者:Stephen Ansell、North Central Cancer Treatment Group
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
rituximabの臨床試験
-
Aprea Therapeutics終了しましたマントル細胞リンパ腫 | 慢性リンパ性白血病 | 非ホジキンリンパ腫アメリカ