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Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

2 oktober 2018 uppdaterad av: National Cancer Institute (NCI)

A Phase II Trial of Bortezomib (NSC #681239) + Lenalidomide (Revlimid™, CC-5013) (NSC #703813) for Relapsed/Refractory Mantle Cell Lymphoma

This phase II trial studies how well bortezomib and lenalidomide work in treating patients with mantle cell lymphoma that has come back after a period of improvement (refractory) or is not responding to treatment (refractory). Bortezomib may also stop the growth of cancer cells by blocking some proteins needed for cell growth. Lenalidomide may stimulate the immune system to kill cancer cells and may also block the growth of new blood vessels necessary for cell growth. Giving bortezomib with lenalidomide may be an effective treatment for relapsed or refractory mantle cell lymphoma.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

53

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Anaheim, California, Förenta staterna, 92806
        • Kaiser Permanente-Anaheim
      • Baldwin Park, California, Förenta staterna, 91706
        • Kaiser Permanente-Baldwin Park
      • Bellflower, California, Förenta staterna, 90706
        • Kaiser Permanente-Bellflower
      • Fontana, California, Förenta staterna, 92335
        • Kaiser Permanente-Fontana
      • Harbor City, California, Förenta staterna, 90710
        • Kaiser Permanente - Harbor City
      • Irvine, California, Förenta staterna, 92618
        • Kaiser Permanente-Irvine
      • Los Angeles, California, Förenta staterna, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, Förenta staterna, 90034
        • Kaiser Permanente-Cadillac
      • Panorama City, California, Förenta staterna, 91402
        • Kaiser Permanente - Panorama City
      • Riverside, California, Förenta staterna, 92505
        • Kaiser Permanente-Riverside
      • San Diego, California, Förenta staterna, 92120
        • Kaiser Permanente-San Diego Zion
      • San Diego, California, Förenta staterna, 92108
        • Kaiser Permanente-San Diego Mission
      • San Marcos, California, Förenta staterna, 92078
        • Kaiser Permanente-San Marcos
      • Woodland Hills, California, Förenta staterna, 91367
        • Kaiser Permanente-Woodland Hills
    • Connecticut
      • Hartford, Connecticut, Förenta staterna, 06102
        • Hartford Hospital
    • Delaware
      • Lewes, Delaware, Förenta staterna, 19958
        • Beebe Medical Center
      • Newark, Delaware, Förenta staterna, 19718
        • Christiana Care Health System-Christiana Hospital
    • District of Columbia
      • Washington, District of Columbia, Förenta staterna, 20007
        • MedStar Georgetown University Hospital
    • Illinois
      • Canton, Illinois, Förenta staterna, 61520
        • Graham Hospital Association
      • Carthage, Illinois, Förenta staterna, 62321
        • Memorial Hospital
      • Chicago, Illinois, Förenta staterna, 60637
        • University of Chicago Comprehensive Cancer Center
      • Decatur, Illinois, Förenta staterna, 62526
        • Heartland Cancer Research NCORP
      • Eureka, Illinois, Förenta staterna, 61530
        • Eureka Hospital
      • Galesburg, Illinois, Förenta staterna, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, Förenta staterna, 61401
        • Illinois CancerCare-Galesburg
      • Galesburg, Illinois, Förenta staterna, 61401
        • Galesburg Cottage Hospital
      • Havana, Illinois, Förenta staterna, 62644
        • Mason District Hospital
      • Hopedale, Illinois, Förenta staterna, 61747
        • Hopedale Medical Complex - Hospital
      • Macomb, Illinois, Förenta staterna, 61455
        • Mcdonough District Hospital
      • Normal, Illinois, Förenta staterna, 61761
        • Community Cancer Center Foundation
      • Normal, Illinois, Förenta staterna, 61761
        • Bromenn Regional Medical Center
      • Ottawa, Illinois, Förenta staterna, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, Förenta staterna, 61350
        • Ottawa Regional Hospital and Healthcare Center
      • Pekin, Illinois, Förenta staterna, 61554
        • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
      • Pekin, Illinois, Förenta staterna, 61554
        • Pekin Hospital
      • Peoria, Illinois, Förenta staterna, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Förenta staterna, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, Förenta staterna, 61614
        • Proctor Hospital
      • Peru, Illinois, Förenta staterna, 61354
        • Valley Radiation Oncology
      • Peru, Illinois, Förenta staterna, 61354
        • Illinois Valley Hospital
      • Princeton, Illinois, Förenta staterna, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, Förenta staterna, 61362
        • Saint Margaret's Hospital
    • Indiana
      • Fort Wayne, Indiana, Förenta staterna, 46845
        • Fort Wayne Medical Oncology and Hematology Inc-Parkview
    • Iowa
      • Bettendorf, Iowa, Förenta staterna, 52722
        • University of Iowa Healthcare Cancer Services Quad Cities
      • Iowa City, Iowa, Förenta staterna, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Maine
      • Augusta, Maine, Förenta staterna, 04330
        • Harold Alfond Center for Cancer Care
      • Bangor, Maine, Förenta staterna, 04401
        • Eastern Maine Medical Center
    • Maryland
      • Elkton, Maryland, Förenta staterna, 21921
        • Union Hospital of Cecil County
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Förenta staterna, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Förenta staterna, 02114
        • Massachusetts General Hospital Cancer Center
      • Newton, Massachusetts, Förenta staterna, 02462
        • Newton-Wellesley Hospital
    • Michigan
      • Battle Creek, Michigan, Förenta staterna, 49017
        • Bronson Battle Creek
      • Big Rapids, Michigan, Förenta staterna, 49307
        • Spectrum Health Big Rapids Hospital
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • Mercy Health Saint Mary's
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • Cancer Research Consortium of West Michigan NCORP
      • Muskegon, Michigan, Förenta staterna, 49444
        • Mercy Health Mercy Campus
      • Traverse City, Michigan, Förenta staterna, 49684
        • Munson Medical Center
      • Wyoming, Michigan, Förenta staterna, 49519
        • Metro Health Hospital
    • Minnesota
      • Minneapolis, Minnesota, Förenta staterna, 55455
        • University of Minnesota/Masonic Cancer Center
      • Minneapolis, Minnesota, Förenta staterna, 55417
        • Minneapolis Veterans Medical Center
    • Missouri
      • Columbia, Missouri, Förenta staterna, 65212
        • University of Missouri - Ellis Fischel
      • Columbia, Missouri, Förenta staterna, 65201
        • Veterans Administration
      • Saint Louis, Missouri, Förenta staterna, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, Förenta staterna, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Camden, New Jersey, Förenta staterna, 08103
        • Cooper Hospital University Medical Center
    • New York
      • Buffalo, New York, Förenta staterna, 14263
        • Roswell Park Cancer Institute
      • East Syracuse, New York, Förenta staterna, 13057
        • Hematology Oncology Associates of Central New York-East Syracuse
      • Syracuse, New York, Förenta staterna, 13210
        • State University of New York Upstate Medical University
    • North Carolina
      • Asheville, North Carolina, Förenta staterna, 28801
        • Mission Hospital Inc-Memorial Campus
      • Charlotte, North Carolina, Förenta staterna, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Charlotte, North Carolina, Förenta staterna, 28204
        • Novant Health Presbyterian Medical Center
      • Goldsboro, North Carolina, Förenta staterna, 27534
        • Wayne Memorial Hospital
      • Kinston, North Carolina, Förenta staterna, 28501
        • Vidant Oncology-Kinston
      • Winston-Salem, North Carolina, Förenta staterna, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Columbus, Ohio, Förenta staterna, 43210
        • Ohio State University Comprehensive Cancer Center
    • South Carolina
      • Florence, South Carolina, Förenta staterna, 29506
        • McLeod Regional Medical Center
    • Vermont
      • Berlin, Vermont, Förenta staterna, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, Förenta staterna, 05405
        • University of Vermont College of Medicine
    • Virginia
      • Danville, Virginia, Förenta staterna, 24541
        • Danville Regional Medical Center
      • Martinsville, Virginia, Förenta staterna, 24115
        • Sovah Health Martinsville

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: Laboratoriebiomarköranalys
Korrelativa studier
Läkemedel: Lenalidomid
Givet PO
Andra namn:
  • CC-5013
  • Revlimid
  • CC5013
  • CDC 501
Läkemedel: Bortezomib
Givet IV
Andra namn:
  • Velcade
  • MLN341
  • PS-341
  • LDP 341
  • [(lR)-3-metyl-1-[[(2S)-1-oxo-3-fenyl-2-[(pyrazinylkarbonyl)amino]propyl]amino]butyl]borsyra
  • PS341

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With an Overall Response Defined as Complete Response and Partial Response
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of Adverse Events
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Vicki Morrison, Alliance for Clinical Trials in Oncology

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 november 2007

Primärt slutförande (Faktisk)

31 december 2012

Avslutad studie (Faktisk)

21 januari 2014

Studieregistreringsdatum

Först inskickad

2 november 2007

Först inskickad som uppfyllde QC-kriterierna

2 november 2007

Första postat (Uppskatta)

4 november 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 oktober 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 oktober 2018

Senast verifierad

1 oktober 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NCI-2009-00483 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • U10CA180821 (U.S.S. NIH-anslag/kontrakt)
  • U10CA031946 (U.S.S. NIH-anslag/kontrakt)
  • CDR0000573827
  • CALGB 50501 (Annan identifierare: Alliance for Clinical Trials in Oncology)
  • CALGB-50501 (Annan identifierare: CTEP)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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