Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
A Phase II Trial of Bortezomib (NSC #681239) + Lenalidomide (Revlimid™, CC-5013) (NSC #703813) for Relapsed/Refractory Mantle Cell Lymphoma
調査の概要
詳細な説明
PRIMARY OBJECTIVES:
I. To determine the overall response (complete response [CR] and partial response [PR]) rate and the complete response (CR) rate to bortezomib + lenalidomide therapy in patients with relapsed or refractory mantle cell lymphoma.
SECONDARY OBJECTIVES:
I. To determine the time to progression after therapy with bortezomib + lenalidomide in patients with relapsed or refractory mantle cell lymphoma.
II. To determine the disease-free survival and overall survival after therapy with bortezomib + lenalidomide in patients with relapsed or refractory mantle cell lymphoma.
OUTLINE:
Patients receive induction therapy comprising bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide orally (PO) once daily (QD) on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib IV on days 1 and 8 and lenalidomide PO QD on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, 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
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California
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Anaheim、California、アメリカ、92806
- Kaiser Permanente-Anaheim
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Baldwin Park、California、アメリカ、91706
- Kaiser Permanente-Baldwin Park
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Bellflower、California、アメリカ、90706
- Kaiser Permanente-Bellflower
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Fontana、California、アメリカ、92335
- Kaiser Permanente-Fontana
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Harbor City、California、アメリカ、90710
- Kaiser Permanente - Harbor City
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Irvine、California、アメリカ、92618
- Kaiser Permanente-Irvine
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Los Angeles、California、アメリカ、90027
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles、California、アメリカ、90034
- Kaiser Permanente-Cadillac
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Panorama City、California、アメリカ、91402
- Kaiser Permanente - Panorama City
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Riverside、California、アメリカ、92505
- Kaiser Permanente-Riverside
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San Diego、California、アメリカ、92120
- Kaiser Permanente-San Diego Zion
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San Diego、California、アメリカ、92108
- Kaiser Permanente-San Diego Mission
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San Marcos、California、アメリカ、92078
- Kaiser Permanente-San Marcos
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Woodland Hills、California、アメリカ、91367
- Kaiser Permanente-Woodland Hills
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Connecticut
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Hartford、Connecticut、アメリカ、06102
- Hartford Hospital
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Delaware
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Lewes、Delaware、アメリカ、19958
- Beebe Medical Center
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Newark、Delaware、アメリカ、19718
- Christiana Care Health System-Christiana Hospital
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District of Columbia
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Washington、District of Columbia、アメリカ、20007
- MedStar Georgetown University Hospital
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Illinois
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Canton、Illinois、アメリカ、61520
- Graham Hospital Association
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Carthage、Illinois、アメリカ、62321
- Memorial Hospital
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Chicago、Illinois、アメリカ、60637
- University of Chicago Comprehensive Cancer Center
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Decatur、Illinois、アメリカ、62526
- Heartland Cancer Research NCORP
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Eureka、Illinois、アメリカ、61530
- Eureka Hospital
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Galesburg、Illinois、アメリカ、61401
- Western Illinois Cancer Treatment Center
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Galesburg、Illinois、アメリカ、61401
- Illinois CancerCare-Galesburg
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Galesburg、Illinois、アメリカ、61401
- Galesburg Cottage Hospital
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Havana、Illinois、アメリカ、62644
- Mason District Hospital
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Hopedale、Illinois、アメリカ、61747
- Hopedale Medical Complex - Hospital
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Macomb、Illinois、アメリカ、61455
- Mcdonough District Hospital
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Normal、Illinois、アメリカ、61761
- Community Cancer Center Foundation
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Normal、Illinois、アメリカ、61761
- Bromenn Regional Medical Center
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Ottawa、Illinois、アメリカ、61350
- Illinois CancerCare-Ottawa Clinic
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Ottawa、Illinois、アメリカ、61350
- Ottawa Regional Hospital and Healthcare Center
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Pekin、Illinois、アメリカ、61554
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
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Pekin、Illinois、アメリカ、61554
- Pekin Hospital
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Peoria、Illinois、アメリカ、61636
- Methodist Medical Center of Illinois
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Peoria、Illinois、アメリカ、61615
- Illinois CancerCare-Peoria
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Peoria、Illinois、アメリカ、61614
- Proctor Hospital
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Peru、Illinois、アメリカ、61354
- Valley Radiation Oncology
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Peru、Illinois、アメリカ、61354
- Illinois Valley Hospital
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Princeton、Illinois、アメリカ、61356
- Perry Memorial Hospital
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Spring Valley、Illinois、アメリカ、61362
- Saint Margaret's Hospital
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Indiana
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Fort Wayne、Indiana、アメリカ、46845
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
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Iowa
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Bettendorf、Iowa、アメリカ、52722
- University of Iowa Healthcare Cancer Services Quad Cities
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Iowa City、Iowa、アメリカ、52242
- University of Iowa/Holden Comprehensive Cancer Center
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Maine
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Augusta、Maine、アメリカ、04330
- Harold Alfond Center for Cancer Care
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Bangor、Maine、アメリカ、04401
- Eastern Maine Medical Center
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Maryland
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Elkton、Maryland、アメリカ、21921
- Union Hospital of Cecil County
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Dana-Farber Cancer Institute
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Boston、Massachusetts、アメリカ、02115
- Brigham and Women's Hospital
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital Cancer Center
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Newton、Massachusetts、アメリカ、02462
- Newton-Wellesley Hospital
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Michigan
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Battle Creek、Michigan、アメリカ、49017
- Bronson Battle Creek
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Big Rapids、Michigan、アメリカ、49307
- Spectrum Health Big Rapids Hospital
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Grand Rapids、Michigan、アメリカ、49503
- Spectrum Health at Butterworth Campus
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Grand Rapids、Michigan、アメリカ、49503
- Mercy Health Saint Mary's
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Grand Rapids、Michigan、アメリカ、49503
- Cancer Research Consortium of West Michigan NCORP
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Muskegon、Michigan、アメリカ、49444
- Mercy Health Mercy Campus
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Traverse City、Michigan、アメリカ、49684
- Munson Medical Center
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Wyoming、Michigan、アメリカ、49519
- Metro Health Hospital
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota/Masonic Cancer Center
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Minneapolis、Minnesota、アメリカ、55417
- Minneapolis Veterans Medical Center
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Missouri
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Columbia、Missouri、アメリカ、65212
- University of Missouri - Ellis Fischel
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Columbia、Missouri、アメリカ、65201
- Veterans Administration
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Saint Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
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New Hampshire
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Lebanon、New Hampshire、アメリカ、03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Camden、New Jersey、アメリカ、08103
- Cooper Hospital University Medical Center
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New York
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Buffalo、New York、アメリカ、14263
- Roswell Park Cancer Institute
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East Syracuse、New York、アメリカ、13057
- Hematology Oncology Associates of Central New York-East Syracuse
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Syracuse、New York、アメリカ、13210
- State University of New York Upstate Medical University
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North Carolina
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Asheville、North Carolina、アメリカ、28801
- Mission Hospital Inc-Memorial Campus
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Charlotte、North Carolina、アメリカ、28203
- Carolinas Medical Center/Levine Cancer Institute
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Charlotte、North Carolina、アメリカ、28204
- Novant Health Presbyterian Medical Center
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Goldsboro、North Carolina、アメリカ、27534
- Wayne Memorial Hospital
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Kinston、North Carolina、アメリカ、28501
- Vidant Oncology-Kinston
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Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest University Health Sciences
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Ohio
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Columbus、Ohio、アメリカ、43210
- Ohio State University Comprehensive Cancer Center
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South Carolina
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Florence、South Carolina、アメリカ、29506
- McLeod Regional Medical Center
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Vermont
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Berlin、Vermont、アメリカ、05602
- Central Vermont Medical Center/National Life Cancer Treatment
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Burlington、Vermont、アメリカ、05405
- University of Vermont College of Medicine
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Virginia
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Danville、Virginia、アメリカ、24541
- Danville Regional Medical Center
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Martinsville、Virginia、アメリカ、24115
- Sovah Health Martinsville
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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 documented mantle cell lymphoma, with the following immunophenotypic characteristics: cluster of differentiation (CD)5+, CD23-, cyclin D1+; this may be from an initial diagnostic biopsy, or one obtained at time of relapse
- Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine needle aspirates are not acceptable
- Failure to submit pathology specimens within 60 days of patient registration will be considered a major protocol violation
- Institutional flow cytometry or immunohistochemistry must confirm CD5 antigen expression, lack of CD23 antigen expression, and expression of cyclin D1
- Prior therapy with at least one regimen, which may have been single agent or multi-agent, and consisted of traditional cytotoxic agents and/or biologic agents; patient may not have received prior bortezomib or lenalidomide therapy; patient must have progressive disease or refractory disease following that initial regimen(s); refractory disease will be defined as stable disease (SD) or progressive disease (PD) as best response to prior therapy, or CR or PR as initial response followed by disease progression within 6 months
- Prior autologous, but not allogeneic, stem cell transplant is allowed
- No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease; maintenance therapy dose may not exceed 20 mg/day prednisone or equivalent
- No prior radioimmunotherapy within 12 months of study entry
- No >= grade 3 peripheral neuropathy within a month prior to study entry
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass > 1 cm by physical exam, computed tomography (CT), magnetic resonance imaging (MRI), or conventional radiograph is acceptable; lesions that are considered non-measurable include the following:
- Bone lesions (lesions, if present, should be noted)
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis or pulmonis
- Bone marrow (involvement by non-Hodgkin lymphoma should be noted)
- No known central nervous system (CNS) involvement by lymphoma
- Patients with human immunodeficiency virus (HIV) infection are eligible, provided they meet the following: CD4+ cell count > 350/mm^3; treatment sensitive HIV and, if on anti-HIV therapy, HIV viral load < 50 copies/mm^3; no history of acquired immunodeficiency syndrome (AIDS)-defining conditions or other HIV-related illnesses; no concurrent zidovudine or stavudine
- Non-pregnant and non-nursing; females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to registration; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure; documentation of counseling is required on Cancer and Leukemia Group B (CALGB) form S-041
- Patients with a recent history (within 3 months of study entry) of deep vein thrombosis (DVT)/pulmonary embolism (PE) are not eligible; patients with a distant history (greater than 3 months before study entry) of DVT/PE are eligible, but must receive either prophylactic aspirin or low molecular weight heparin, unless contraindicated
- Left ventricular ejection fraction (LVEF) >= 45% by multigated acquisition (MUGA) scan or echocardiogram
- No New York Heart Association class III or class IV congestive heart failure at study entry
- No myocardial infarction within the past 6 months of study entry
- No known positivity for hepatitis A, B, or C
- Absolute neutrophil count (ANC) >= 1,000/uL (>= 500/uL if marrow involvement)
- Platelets >= 75,000/uL
- Creatinine =< 1.5 x upper limit of normal (ULN) (unless attributable to non-Hodgkin's lymphoma) and estimated creatinine clearance >= 30 mL/min (patients on dialysis are not eligible)
- Total bilirubin =< 2 x ULN (unless attributable to non-Hodgkin's lymphoma and Gilbert's disease)
- Urine (U)-human chorionic gonadotropin (HCG) or serum HCG negative
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:Treatment (bortezomib, lenalidomide)
Patients receive induction therapy comprising bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide PO QD on days 1-14.
Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib IV on days 1 and 8 and lenalidomide PO QD on days 1-14.
Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
|
相関研究
与えられたPO
他の名前:
与えられた 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 |
---|---|---|
Number of Participants With an Overall Response Defined as Complete Response and Partial Response
時間枠:Duration of treatment (assessed up to 6 years)
|
Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease. |
Duration of treatment (assessed up to 6 years)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Incidence of Adverse Events
時間枠:Duration of Treatment (up to 6 years)
|
Number of participants who experienced a maximum grade 3, 4 or 5 adverse event.
The grading scales found in the revised NCI CTCAE version 4.0 was utilized for adverse event reporting
|
Duration of Treatment (up to 6 years)
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Time to Progression
時間枠:Assessed up to 6 years
|
Time to progression (TTP) is defined as the time from study entry until progression or death due to any cause.
The median TTP with 95% CI was estimated using the Kaplan-Meier method.
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Assessed up to 6 years
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Overall Survival
時間枠:Assessed up to 6 years
|
Overall survival (OS) is defined as the time from study entry until death.
The median OS with 95% CI was estimated using the Kaplan-Meier method..
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Assessed up to 6 years
|
協力者と研究者
捜査官
- 主任研究者:Vicki Morrison、Alliance for Clinical Trials in Oncology
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NCI-2009-00483 (レジストリ識別子:CTRP (Clinical Trial Reporting Program))
- U10CA180821 (米国 NIH グラント/契約)
- U10CA031946 (米国 NIH グラント/契約)
- CDR0000573827
- CALGB 50501 (その他の識別子:Alliance for Clinical Trials in Oncology)
- CALGB-50501 (その他の識別子:CTEP)
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。
研究室のバイオマーカー分析の臨床試験
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ORIOL BESTARD完了腎臓移植 | CMV感染スペイン, ベルギー
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Central and North West London NHS Foundation TrustBritish HIV Association (BHIVA)まだ募集していませんHIV感染症 | B型肝炎
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Hvidovre University HospitalElsassFonden終了しました
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McGill University Health Centre/Research Institute...Northwestern University募集
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Nantes University Hospital完了
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Fundació Sant Joan de DéuStanley Medical Research Institute; Parc Sanitari Sant Joan de Déu; Hospital Sant Joan de Deu完了