- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00553644
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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California
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Anaheim, California, Vereinigte Staaten, 92806
- Kaiser Permanente-Anaheim
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Baldwin Park, California, Vereinigte Staaten, 91706
- Kaiser Permanente-Baldwin Park
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Bellflower, California, Vereinigte Staaten, 90706
- Kaiser Permanente-Bellflower
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Fontana, California, Vereinigte Staaten, 92335
- Kaiser Permanente-Fontana
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Harbor City, California, Vereinigte Staaten, 90710
- Kaiser Permanente - Harbor City
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Irvine, California, Vereinigte Staaten, 92618
- Kaiser Permanente-Irvine
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Los Angeles, California, Vereinigte Staaten, 90027
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, Vereinigte Staaten, 90034
- Kaiser Permanente-Cadillac
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Panorama City, California, Vereinigte Staaten, 91402
- Kaiser Permanente - Panorama City
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Riverside, California, Vereinigte Staaten, 92505
- Kaiser Permanente-Riverside
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San Diego, California, Vereinigte Staaten, 92120
- Kaiser Permanente-San Diego Zion
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San Diego, California, Vereinigte Staaten, 92108
- Kaiser Permanente-San Diego Mission
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San Marcos, California, Vereinigte Staaten, 92078
- Kaiser Permanente-San Marcos
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Woodland Hills, California, Vereinigte Staaten, 91367
- Kaiser Permanente-Woodland Hills
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Connecticut
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Hartford, Connecticut, Vereinigte Staaten, 06102
- Hartford Hospital
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Delaware
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Lewes, Delaware, Vereinigte Staaten, 19958
- Beebe Medical Center
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Newark, Delaware, Vereinigte Staaten, 19718
- Christiana Care Health System-Christiana Hospital
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District of Columbia
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Washington, District of Columbia, Vereinigte Staaten, 20007
- MedStar Georgetown University Hospital
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Illinois
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Canton, Illinois, Vereinigte Staaten, 61520
- Graham Hospital Association
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Carthage, Illinois, Vereinigte Staaten, 62321
- Memorial Hospital
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Chicago, Illinois, Vereinigte Staaten, 60637
- University of Chicago Comprehensive Cancer Center
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Decatur, Illinois, Vereinigte Staaten, 62526
- Heartland Cancer Research NCORP
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Eureka, Illinois, Vereinigte Staaten, 61530
- Eureka Hospital
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Galesburg, Illinois, Vereinigte Staaten, 61401
- Western Illinois Cancer Treatment Center
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Galesburg, Illinois, Vereinigte Staaten, 61401
- Illinois CancerCare-Galesburg
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Galesburg, Illinois, Vereinigte Staaten, 61401
- Galesburg Cottage Hospital
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Havana, Illinois, Vereinigte Staaten, 62644
- Mason District Hospital
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Hopedale, Illinois, Vereinigte Staaten, 61747
- Hopedale Medical Complex - Hospital
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Macomb, Illinois, Vereinigte Staaten, 61455
- Mcdonough District Hospital
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Normal, Illinois, Vereinigte Staaten, 61761
- Community Cancer Center Foundation
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Normal, Illinois, Vereinigte Staaten, 61761
- Bromenn Regional Medical Center
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Ottawa, Illinois, Vereinigte Staaten, 61350
- Illinois CancerCare-Ottawa Clinic
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Ottawa, Illinois, Vereinigte Staaten, 61350
- Ottawa Regional Hospital and Healthcare Center
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Pekin, Illinois, Vereinigte Staaten, 61554
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
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Pekin, Illinois, Vereinigte Staaten, 61554
- Pekin Hospital
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Peoria, Illinois, Vereinigte Staaten, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Vereinigte Staaten, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Vereinigte Staaten, 61614
- Proctor Hospital
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Peru, Illinois, Vereinigte Staaten, 61354
- Valley Radiation Oncology
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Peru, Illinois, Vereinigte Staaten, 61354
- Illinois Valley Hospital
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Princeton, Illinois, Vereinigte Staaten, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Vereinigte Staaten, 61362
- Saint Margaret's Hospital
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Indiana
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Fort Wayne, Indiana, Vereinigte Staaten, 46845
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
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Iowa
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Bettendorf, Iowa, Vereinigte Staaten, 52722
- University of Iowa Healthcare Cancer Services Quad Cities
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Iowa City, Iowa, Vereinigte Staaten, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Maine
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Augusta, Maine, Vereinigte Staaten, 04330
- Harold Alfond Center for Cancer Care
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Bangor, Maine, Vereinigte Staaten, 04401
- Eastern Maine Medical Center
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Maryland
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Elkton, Maryland, Vereinigte Staaten, 21921
- Union Hospital of Cecil County
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General Hospital Cancer Center
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Newton, Massachusetts, Vereinigte Staaten, 02462
- Newton-Wellesley Hospital
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Michigan
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Battle Creek, Michigan, Vereinigte Staaten, 49017
- Bronson Battle Creek
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Big Rapids, Michigan, Vereinigte Staaten, 49307
- Spectrum Health Big Rapids Hospital
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Grand Rapids, Michigan, Vereinigte Staaten, 49503
- Spectrum Health at Butterworth Campus
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Grand Rapids, Michigan, Vereinigte Staaten, 49503
- Mercy Health Saint Mary's
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Grand Rapids, Michigan, Vereinigte Staaten, 49503
- Cancer Research Consortium of West Michigan NCORP
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Muskegon, Michigan, Vereinigte Staaten, 49444
- Mercy Health Mercy Campus
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Traverse City, Michigan, Vereinigte Staaten, 49684
- Munson Medical Center
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Wyoming, Michigan, Vereinigte Staaten, 49519
- Metro Health Hospital
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55455
- University of Minnesota/Masonic Cancer Center
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Minneapolis, Minnesota, Vereinigte Staaten, 55417
- Minneapolis Veterans Medical Center
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Missouri
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Columbia, Missouri, Vereinigte Staaten, 65212
- University of Missouri - Ellis Fischel
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Columbia, Missouri, Vereinigte Staaten, 65201
- Veterans Administration
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Saint Louis, Missouri, Vereinigte Staaten, 63110
- Washington University School of Medicine
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New Hampshire
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Lebanon, New Hampshire, Vereinigte Staaten, 03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Camden, New Jersey, Vereinigte Staaten, 08103
- Cooper Hospital University Medical Center
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New York
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Buffalo, New York, Vereinigte Staaten, 14263
- Roswell Park Cancer Institute
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East Syracuse, New York, Vereinigte Staaten, 13057
- Hematology Oncology Associates of Central New York-East Syracuse
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Syracuse, New York, Vereinigte Staaten, 13210
- State University of New York Upstate Medical University
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North Carolina
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Asheville, North Carolina, Vereinigte Staaten, 28801
- Mission Hospital Inc-Memorial Campus
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Charlotte, North Carolina, Vereinigte Staaten, 28203
- Carolinas Medical Center/Levine Cancer Institute
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Charlotte, North Carolina, Vereinigte Staaten, 28204
- Novant Health Presbyterian Medical Center
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Goldsboro, North Carolina, Vereinigte Staaten, 27534
- Wayne Memorial Hospital
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Kinston, North Carolina, Vereinigte Staaten, 28501
- Vidant Oncology-Kinston
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Winston-Salem, North Carolina, Vereinigte Staaten, 27157
- Wake Forest University Health Sciences
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Ohio
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Columbus, Ohio, Vereinigte Staaten, 43210
- Ohio State University Comprehensive Cancer Center
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South Carolina
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Florence, South Carolina, Vereinigte Staaten, 29506
- McLeod Regional Medical Center
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Vermont
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Berlin, Vermont, Vereinigte Staaten, 05602
- Central Vermont Medical Center/National Life Cancer Treatment
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Burlington, Vermont, Vereinigte Staaten, 05405
- University of Vermont College of Medicine
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Virginia
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Danville, Virginia, Vereinigte Staaten, 24541
- Danville Regional Medical Center
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Martinsville, Virginia, Vereinigte Staaten, 24115
- Sovah Health Martinsville
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
|
Korrelative Studien
PO gegeben
Andere Namen:
Gegeben IV
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Participants With an Overall Response Defined as Complete Response and Partial Response
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Incidence of Adverse Events
Zeitfenster: 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)
|
Time to Progression
Zeitfenster: 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.
|
Assessed up to 6 years
|
Overall Survival
Zeitfenster: 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..
|
Assessed up to 6 years
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Vicki Morrison, Alliance for Clinical Trials in Oncology
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Lymphoproliferative Erkrankungen
- Lymphatische Erkrankungen
- Immunproliferative Erkrankungen
- Lymphom, Non-Hodgkin
- Lymphom
- Lymphom, Mantelzelle
- Physiologische Wirkungen von Arzneimitteln
- Antineoplastische Mittel
- Immunologische Faktoren
- Angiogenese-Inhibitoren
- Angiogenese-modulierende Mittel
- Wuchsstoffe
- Wachstumshemmer
- Lenalidomid
- Bortezomib
Andere Studien-ID-Nummern
- NCI-2009-00483 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
- U10CA180821 (US NIH Stipendium/Vertrag)
- U10CA031946 (US NIH Stipendium/Vertrag)
- CDR0000573827
- CALGB 50501 (Andere Kennung: Alliance for Clinical Trials in Oncology)
- CALGB-50501 (Andere Kennung: CTEP)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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