Chimiothérapie combinée avec ou sans greffe autologue de cellules souches dans le traitement des patients atteints d'un lymphome à cellules B du système nerveux central
31 août 2026 mis à jour par: Alliance for Clinical Trials in Oncology
Un essai randomisé de phase II sur la chimiothérapie de consolidation myéloablative versus non myéloablative pour le lymphome à cellules B primitif du SNC nouvellement diagnostiqué
The purpose of this study is to find out what effects (good and/or bad) treatment with chemotherapy and stem cell transplant compared with chemotherapy alone will have on primary CNS B-cell lymphoma. Currently the best treatment for patients with primary CNS B-cell lymphoma is not known.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Primary Objective:
To compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of HDT/ASCT versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide
Secondary Objectives:
- To compare the two-year event-free survival (EFS) of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine
- To compare the overall survival (OS) of patients treated with the consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine
- To assess the toxicities associated with consolidation HDT/ASCT versus consolidation consisting of etoposide and cytarabine
- To determine diffusion MRI metrics (ADCmini, ADC25%, and ADCmean) prior to induction chemotherapy, after one full induction chemotherapy cycle, and at the end of induction chemotherapy as a predictor of response and outcome (CALGB 581101)
- To determine brain FDG-PET metrics (tumor SUV and tumor versus background SUV) prior to induction chemotherapy, after one full induction chemotherapy cycle, and at the end of induction chemotherapy as a predictor of response and outcome (CALGB 581101)
- To determine whether low baseline ADC measurements are associated with shorter PFS and OS (CALGB 581101)
- To determine whether reduction in tumor SUV by > 25% on brain FDG-PET/CT after one cycle of induction therapy is associated with improved PFS and OS (CALGB 581101)
- To determine which IHC-based biomarkers are predictive of an adverse prognosis (CALGB 151113)
- To determine which IHC-based biomarkers are predictive of a favorable prognosis (CALGB 151113) for BCL6 (B-cell CLL/lymphoma 6), and STAT 6 (signal transducer and activator of transcription 6, interleukin-4 induced)
- To analyze tumor tissue for gene expression profiles, and to correlate these profiles with treatment outcomes (CALGB 151113)
- To determine whether CSF proteome is a predictor of outcomes (prognostic marker) irrespective of treatment arm (CALGB 151113) for (IL-10 (interleukin 10) and C3 (complement component 3)
- To assess the neurocognitive function of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy (etoposide and cytarabine) as measured by serial administration of the International PCNSL Collaborative Group (IPCG) neurocognitive battery and evaluate the long-term survivorship differences between the two arms (CALGB 71105)
Type d'étude
Interventionnel
Inscription (Réel)
113
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alaska
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Anchorage, Alaska, États-Unis, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, États-Unis, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, États-Unis, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, États-Unis, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, États-Unis, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, États-Unis, 99508
- Katmai Oncology Group
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Anchorage, Alaska, États-Unis, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, États-Unis, 99504
- Anchorage Radiation Therapy Center
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California
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Burbank, California, États-Unis, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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La Jolla, California, États-Unis, 92093
- UC San Diego Moores Cancer Center
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Sacramento, California, États-Unis, 95817
- University of California Davis Comprehensive Cancer Center
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San Francisco, California, États-Unis, 94115
- UCSF Medical Center-Mount Zion
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San Francisco, California, États-Unis, 94143
- UCSF Medical Center-Parnassus
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Connecticut
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New Haven, Connecticut, États-Unis, 06520
- Yale University
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Florida
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Tampa, Florida, États-Unis, 33612
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Emory University/Winship Cancer Institute
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Idaho
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Boise, Idaho, États-Unis, 83712
- Saint Luke's Mountain States Tumor Institute
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Fruitland, Idaho, États-Unis, 83619
- Saint Luke's Mountain States Tumor Institute - Fruitland
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Meridian, Idaho, États-Unis, 83642
- Saint Luke's Mountain States Tumor Institute - Meridian
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Nampa, Idaho, États-Unis, 83686
- Saint Luke's Mountain States Tumor Institute - Nampa
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Twin Falls, Idaho, États-Unis, 83301
- Saint Luke's Mountain States Tumor Institute-Twin Falls
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Illinois
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Chicago, Illinois, États-Unis, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, États-Unis, 60612
- University of Illinois
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Indiana
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Richmond, Indiana, États-Unis, 47374
- Reid Health
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Kansas
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Kansas City, Kansas, États-Unis, 66160
- University of Kansas Cancer Center
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Kentucky
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Crestview Hills, Kentucky, États-Unis, 41017
- Oncology Hematology Care Inc-Crestview
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Louisiana
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New Orleans, Louisiana, États-Unis, 70112
- Tulane University Health Sciences Center
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, États-Unis, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Battle Creek, Michigan, États-Unis, 49017
- Bronson Battle Creek
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Grand Rapids, Michigan, États-Unis, 49503
- Spectrum Health at Butterworth Campus
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Grand Rapids, Michigan, États-Unis, 49503
- Mercy Health Saint Mary's
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Kalamazoo, Michigan, États-Unis, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, États-Unis, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, États-Unis, 49001
- Borgess Medical Center
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Muskegon, Michigan, États-Unis, 49444
- Mercy Health Mercy Campus
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Niles, Michigan, États-Unis, 49120
- Lakeland Community Hospital
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Reed City, Michigan, États-Unis, 49677
- Spectrum Health Reed City Hospital
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Saint Joseph, Michigan, États-Unis, 49085
- Marie Yeager Cancer Center
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Saint Joseph, Michigan, États-Unis, 49085
- Lakeland Hospital
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Traverse City, Michigan, États-Unis, 49684
- Munson Medical Center
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Wyoming, Michigan, États-Unis, 49519
- Metro Health Hospital
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
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Nebraska
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Omaha, Nebraska, États-Unis, 68198
- University of Nebraska Medical Center
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New York
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New York, New York, États-Unis, 10065
- Weill Medical College of Cornell University
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Rochester, New York, États-Unis, 14642
- University of Rochester
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Stony Brook, New York, États-Unis, 11794
- Stony Brook University Medical Center
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Syracuse, New York, États-Unis, 13210
- State University of New York Upstate Medical University
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke University Medical Center
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Ohio
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Centerville, Ohio, États-Unis, 45459
- Dayton Physicians LLC-Miami Valley South
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Cincinnati, Ohio, États-Unis, 45242
- Oncology Hematology Care Inc-Blue Ash
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Cincinnati, Ohio, États-Unis, 45202
- Oncology Hematology Care Inc-Eden Park
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Cincinnati, Ohio, États-Unis, 45211
- Oncology Hematology Care Inc-Mercy West
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Cincinnati, Ohio, États-Unis, 45236
- Oncology Hematology Care Inc-Kenwood
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Cincinnati, Ohio, États-Unis, 45230
- Oncology Hematology Care Inc - Anderson
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Dayton, Ohio, États-Unis, 45406
- Good Samaritan Hospital - Dayton
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Dayton, Ohio, États-Unis, 45409
- Miami Valley Hospital
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Dayton, Ohio, États-Unis, 45415
- Dayton Physicians LLC-Samaritan North
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Dayton, Ohio, États-Unis, 45415
- Samaritan North Health Center
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Dayton, Ohio, États-Unis, 45420
- Dayton NCI Community Oncology Research Program
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Fairfield, Ohio, États-Unis, 45014
- Oncology Hematology Care Inc-Healthplex
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Findlay, Ohio, États-Unis, 45840
- Blanchard Valley Hospital
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Findlay, Ohio, États-Unis, 45840
- Armes Family Cancer Center
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Findlay, Ohio, États-Unis, 45840
- Orion Cancer Care
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Franklin, Ohio, États-Unis, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Franklin, Ohio, États-Unis, 45005
- Dayton Physicians LLC-Atrium
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Greenville, Ohio, États-Unis, 45331
- Wayne Hospital
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Greenville, Ohio, États-Unis, 45331
- Dayton Physicians LLC-Wayne
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Kettering, Ohio, États-Unis, 45429
- Kettering Medical Center
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Kettering, Ohio, États-Unis, 45409
- Greater Dayton Cancer Center
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Middletown, Ohio, États-Unis, 45042
- Dayton Physicians LLC-Signal Point
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Sidney, Ohio, États-Unis, 45365
- Dayton Physicians LLC-Wilson
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Springfield, Ohio, États-Unis, 45505
- Springfield Regional Medical Center
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Springfield, Ohio, États-Unis, 45504
- Springfield Regional Cancer Center
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Troy, Ohio, États-Unis, 45373
- Upper Valley Medical Center
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Troy, Ohio, États-Unis, 45373
- Dayton Physicians LLC-Upper Valley
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Oklahoma
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Tulsa, Oklahoma, États-Unis, 74136
- Surgical Associates Inc
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Tulsa, Oklahoma, États-Unis, 74146
- Warren Clinic Oncology-Tulsa
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Oregon
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Bend, Oregon, États-Unis, 97701
- Saint Charles Health System
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Clackamas, Oregon, États-Unis, 97015
- Clackamas Radiation Oncology Center
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Clackamas, Oregon, États-Unis, 97015
- Providence Oncology and Hematology Care Southeast
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Coos Bay, Oregon, États-Unis, 97420
- Bay Area Hospital
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Milwaukie, Oregon, États-Unis, 97222
- Providence Milwaukie Hospital
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Newberg, Oregon, États-Unis, 97132
- Providence Newberg Medical Center
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Oregon City, Oregon, États-Unis, 97045
- Providence Willamette Falls Medical Center
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Portland, Oregon, États-Unis, 97213
- Providence Portland Medical Center
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Portland, Oregon, États-Unis, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Danville, Pennsylvania, États-Unis, 17822
- Geisinger Medical Center
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Lewistown, Pennsylvania, États-Unis, 17044
- Lewistown Hospital
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Pittsburgh, Pennsylvania, États-Unis, 15232
- University of Pittsburgh Cancer Institute (UPCI)
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Utah
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Salt Lake City, Utah, États-Unis, 84112
- Huntsman Cancer Institute/University of Utah
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Vermont
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Berlin Corners, Vermont, États-Unis, 05602
- Central Vermont Medical Center/National Life Cancer Treatment
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Burlington, Vermont, États-Unis, 05401
- University of Vermont Medical Center
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Burlington, Vermont, États-Unis, 05405
- University of Vermont College of Medicine
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Virginia
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Richmond, Virginia, États-Unis, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Washington
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Aberdeen, Washington, États-Unis, 98520
- Providence Regional Cancer System-Aberdeen
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Anacortes, Washington, États-Unis, 98221
- Cancer Care Center at Island Hospital
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Bellevue, Washington, États-Unis, 98005
- Swedish Cancer Institute-Eastside Oncology Hematology
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Bellingham, Washington, États-Unis, 98225
- PeaceHealth Saint Joseph Medical Center
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Centralia, Washington, États-Unis, 98531
- Providence Regional Cancer System-Centralia
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Edmonds, Washington, États-Unis, 98026
- Swedish Medical Center-Edmonds
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Everett, Washington, États-Unis, 98201
- Providence Regional Cancer Partnership
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Issaquah, Washington, États-Unis, 98029
- Swedish Cancer Institute-Issaquah
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Lacey, Washington, États-Unis, 98503
- Providence Regional Cancer System-Lacey
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Longview, Washington, États-Unis, 98632
- PeaceHealth Saint John Medical Center
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Seattle, Washington, États-Unis, 98109
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, États-Unis, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, États-Unis, 98195
- University of Washington Medical Center
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Seattle, Washington, États-Unis, 98107
- Swedish Medical Center-Ballard Campus
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Seattle, Washington, États-Unis, 98104
- Minor and James Medical PLLC
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Seattle, Washington, États-Unis, 98104
- Pacific Gynecology Specialists
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Seattle, Washington, États-Unis, 98112
- Group Health Cooperative-Seattle
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Seattle, Washington, États-Unis, 98122-4307
- Swedish Medical Center-First Hill
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Shelton, Washington, États-Unis, 98584
- Providence Regional Cancer System-Shelton
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Spokane, Washington, États-Unis, 99204
- Rockwood Cancer Treatment Center-DHEC-Downtown
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Spokane Valley, Washington, États-Unis, 99216
- Rockwood Clinic Cancer Treatment Center-Valley
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Vancouver, Washington, États-Unis, 98664
- PeaceHealth Southwest Medical Center
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Vancouver, Washington, États-Unis, 98684
- Compass Oncology Vancouver
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Walla Walla, Washington, États-Unis, 99362
- Providence Saint Mary Regional Cancer Center
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Yakima, Washington, États-Unis, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
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Yelm, Washington, États-Unis, 98597
- Providence Regional Cancer System-Yelm
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Wisconsin
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La Crosse, Wisconsin, États-Unis, 54601
- Mayo Clinic Health System-Franciscan Healthcare
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Madison, Wisconsin, États-Unis, 53792
- University of Wisconsin Hospital and Clinics
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
- Documentation of Disease: Diagnosis of primary CNS diffuse large B-cell lymphoma confirmed by one of the following: brain biopsy or resection, cerebrospinal fluid and vitreous fluid.
- Other Lymphomas: Patients must have no evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS.
- Previous Treatment: Patients must have no prior chemotherapy or radiation therapy for lymphoma.
- Age- Patients must be between the ages of 18 and 75 years.
- Karnofsky Performance Scale - Patients must measure Karnofsky Performance Scale ≥ 30 (≥ 50 for patients ages 60-70).
- Pregnancy and Nursing Status - Patients must be non-pregnant and non-nursing; women of childbearing potential must have a negative serum or urine pregnancy test 10-14 days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)
- HIV - Patients must have negative HIV serology.
- Hepatitis - Patients must have negative HCV serology (unless HBsAb positive patient has recently received HBV vaccine, in this case HBcAb should be negative). All patients must be screened for hepatitis B infection before starting treatment. Those patients who test positive for hepatitis B should be closely monitored for evidence of active HBV infection and hepatitis during and for several months after rituximab treatment. PCNSL patients with a history of hepatitis B infection should be treated with entecavir or lamivudine (physician discretion for choice of drug) as antiviral prophylaxis to prevent hepatitis B reactivation.
- Organ Transplant or Immunosuppressant Therapy - Patient must have no history of organ transplantation or ongoing immunosuppressant therapy.
- Required Initial Laboratory Values: ANC ≥ 1500/mcL, AST and ALT < 2 x upper limit of normal (ULN), total bilirubin ≤ 3 mg/dL, creatinine clearance ≥ 50 mL/min, platelet count ≥ 100,000/mcL
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Arm I
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant. |
Given IV Given IV |
|
Autre: Arm II
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy. |
Given IV Given IV |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression Free Survival
Délai: 2 years
|
The primary endpoint is to compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of HDT/ASCT versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide. PFS time = time from Registration to earliest date of Progression or Death due to any cause, censoring non-progressed and alive patients at the date of last disease status evaluation. Response will be defined using the modified IPCG criteria. Progressive disease is defined as > 25% increase in contrast-enhancing CNS (brain and spine if latter abnormal at baseline) disease, appearance of any new, measurable (>/= 10mm) contrast-enhancing disease or recurrent or new ocular or CSF disease. |
2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Event Free Survival
Délai: 2 years
|
To compare the two-year event-free survival (EFS) of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine. EFS event = same definition as PFS with non-protocol treatment also considered an event |
2 years
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Délai: 7 years
|
Number of patients reporting at least one adverse event at least possibly related to treatment. |
7 years
|
|
Overall Survival
Délai: 2 years
|
To compare the overall survival (OS) of patients treated with the consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine. OS event = Registration/Randomization to Death due to any cause |
2 years
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Tracy Batchelor, MD, MPH, Massachusetts General Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2012
Achèvement primaire (Réel)
14 janvier 2021
Achèvement de l'étude (Réel)
24 février 2022
Dates d'inscription aux études
Première soumission
13 janvier 2012
Première soumission répondant aux critères de contrôle qualité
13 janvier 2012
Première publication (Estimé)
18 janvier 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
- Lymphome diffus à grandes cellules de stade III chez l'adulte
- Lymphome diffus à grandes cellules de stade IV chez l'adulte
- lymphome non hodgkinien primitif du système nerveux central
- Lymphome diffus à grandes cellules non contigu de stade II de l'adulte
- Lymphome diffus à grandes cellules contigu de stade II chez l'adulte
- Lymphome diffus à grandes cellules de stade I de l'adulte
Termes MeSH pertinents supplémentaires
- Tumeurs
- Maladies du système immunitaire
- Tumeurs par type histologique
- Maladies lymphatiques
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Lymphome non hodgkinien
- Lymphome à cellules B
- Maladies hémiques et lymphatiques
- Lymphome
- Lymphome diffus à grandes cellules B
- Peptides
- Acides aminés, peptides et protéines
- Protéines
- Produits chimiques organiques
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Thérapeutique
- Procédures chirurgicales, opératoires
- Acides nucléiques, nucléotides et nucléosides
- Hydrocarbures
- Hydrocarbures, cyclique
- Facteurs biologiques
- Glucides
- Podophyllotoxine
- Tétrahydronaphtalènes
- Naphtalenes
- Hydrocarbures aromatiques polycycliques
- Hydrocarbures, aromatique
- Composés polycycliques
- Glucosides
- Glycosides
- Transplantation
- Amides
- Cytidine
- Nucléosides pyrimidine
- Pyrimidines
- Phosphoramides
- Composés organophosphores
- Nucléosides
- Peptides de signalisation intercellulaire et protéines
- Arabinonucléosides
- Glycoprotéines
- Glycoconjuguis
- Transplantation cellulaire
- Thérapie à base de cellules et de tissus
- Thérapie biologique
- Triéthylènephosphoramide
- Aziridines
- Azirines
- Facteurs de stimulation des colonies
- Facteurs de croissance des cellules hématopoïétiques
- Cytokines
- Composés de nitrosourea
- Urée
- Composés nitroso
- Cytarabine
- Carmustine
- Étoposide
- Thiotépa
- Transplantation de cellules souches
- Facteur de stimulation des colonies granulocytes
Autres numéros d'identification d'étude
- CALGB-51101
- CDR0000721927 (Identificateur de registre: NCI Physician Data Query)
- NCI-2012-00110 (Identificateur de registre: NCI Clinical Trial Reporting Program)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .