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Kombinationskemoterapi med eller utan autolog stamcellstransplantation vid behandling av patienter med B-cellslymfom i det centrala nervsystemet

31 augusti 2026 uppdaterad av: Alliance for Clinical Trials in Oncology

En randomiserad fas II-studie av myeloablativ kontra icke-myeloablativ konsolideringskemoterapi för nyligen diagnostiserat primärt CNS B-cellslymfom

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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:

  1. 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
  2. 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
  3. To assess the toxicities associated with consolidation HDT/ASCT versus consolidation consisting of etoposide and cytarabine
  4. 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)
  5. 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)
  6. To determine whether low baseline ADC measurements are associated with shorter PFS and OS (CALGB 581101)
  7. 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)
  8. To determine which IHC-based biomarkers are predictive of an adverse prognosis (CALGB 151113)
  9. 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)
  10. To analyze tumor tissue for gene expression profiles, and to correlate these profiles with treatment outcomes (CALGB 151113)
  11. 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)
  12. 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)

Studietyp

Interventionell

Inskrivning (Faktisk)

113

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
    • Alaska
      • Anchorage, Alaska, Förenta staterna, 98508
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, Förenta staterna, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, Förenta staterna, 99508
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, Förenta staterna, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Förenta staterna, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Förenta staterna, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, Förenta staterna, 99508
        • Providence Alaska Medical Center
      • Anchorage, Alaska, Förenta staterna, 99504
        • Anchorage Radiation Therapy Center
    • California
      • Burbank, California, Förenta staterna, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • La Jolla, California, Förenta staterna, 92093
        • UC San Diego Moores Cancer Center
      • Sacramento, California, Förenta staterna, 95817
        • University of California Davis Comprehensive Cancer Center
      • San Francisco, California, Förenta staterna, 94115
        • UCSF Medical Center-Mount Zion
      • San Francisco, California, Förenta staterna, 94143
        • UCSF Medical Center-Parnassus
    • Connecticut
      • New Haven, Connecticut, Förenta staterna, 06520
        • Yale University
    • Florida
      • Tampa, Florida, Förenta staterna, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30322
        • Emory University/Winship Cancer Institute
    • Idaho
      • Boise, Idaho, Förenta staterna, 83712
        • Saint Luke's Mountain States Tumor Institute
      • Fruitland, Idaho, Förenta staterna, 83619
        • Saint Luke's Mountain States Tumor Institute - Fruitland
      • Meridian, Idaho, Förenta staterna, 83642
        • Saint Luke's Mountain States Tumor Institute - Meridian
      • Nampa, Idaho, Förenta staterna, 83686
        • Saint Luke's Mountain States Tumor Institute - Nampa
      • Twin Falls, Idaho, Förenta staterna, 83301
        • Saint Luke's Mountain States Tumor Institute-Twin Falls
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Förenta staterna, 60612
        • University of Illinois
    • Indiana
      • Richmond, Indiana, Förenta staterna, 47374
        • Reid Health
    • Kansas
      • Kansas City, Kansas, Förenta staterna, 66160
        • University of Kansas Cancer Center
    • Kentucky
      • Crestview Hills, Kentucky, Förenta staterna, 41017
        • Oncology Hematology Care Inc-Crestview
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna, 70112
        • Tulane University Health Sciences Center
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
    • 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
    • Michigan
      • Battle Creek, Michigan, Förenta staterna, 49017
        • Bronson Battle Creek
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • Mercy Health Saint Mary's
      • Kalamazoo, Michigan, Förenta staterna, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Förenta staterna, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Förenta staterna, 49001
        • Borgess Medical Center
      • Muskegon, Michigan, Förenta staterna, 49444
        • Mercy Health Mercy Campus
      • Niles, Michigan, Förenta staterna, 49120
        • Lakeland Community Hospital
      • Reed City, Michigan, Förenta staterna, 49677
        • Spectrum Health Reed City Hospital
      • Saint Joseph, Michigan, Förenta staterna, 49085
        • Marie Yeager Cancer Center
      • Saint Joseph, Michigan, Förenta staterna, 49085
        • Lakeland Hospital
      • Traverse City, Michigan, Förenta staterna, 49684
        • Munson Medical Center
      • Wyoming, Michigan, Förenta staterna, 49519
        • Metro Health Hospital
    • Minnesota
      • Rochester, Minnesota, Förenta staterna, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, Förenta staterna, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, Förenta staterna, 68198
        • University of Nebraska Medical Center
    • New York
      • New York, New York, Förenta staterna, 10065
        • Weill Medical College of Cornell University
      • Rochester, New York, Förenta staterna, 14642
        • University of Rochester
      • Stony Brook, New York, Förenta staterna, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, Förenta staterna, 13210
        • State University of New York Upstate Medical University
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27710
        • Duke University Medical Center
    • Ohio
      • Centerville, Ohio, Förenta staterna, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Cincinnati, Ohio, Förenta staterna, 45242
        • Oncology Hematology Care Inc-Blue Ash
      • Cincinnati, Ohio, Förenta staterna, 45202
        • Oncology Hematology Care Inc-Eden Park
      • Cincinnati, Ohio, Förenta staterna, 45211
        • Oncology Hematology Care Inc-Mercy West
      • Cincinnati, Ohio, Förenta staterna, 45236
        • Oncology Hematology Care Inc-Kenwood
      • Cincinnati, Ohio, Förenta staterna, 45230
        • Oncology Hematology Care Inc - Anderson
      • Dayton, Ohio, Förenta staterna, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, Förenta staterna, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Förenta staterna, 45415
        • Dayton Physicians LLC-Samaritan North
      • Dayton, Ohio, Förenta staterna, 45415
        • Samaritan North Health Center
      • Dayton, Ohio, Förenta staterna, 45420
        • Dayton NCI Community Oncology Research Program
      • Fairfield, Ohio, Förenta staterna, 45014
        • Oncology Hematology Care Inc-Healthplex
      • Findlay, Ohio, Förenta staterna, 45840
        • Blanchard Valley Hospital
      • Findlay, Ohio, Förenta staterna, 45840
        • Armes Family Cancer Center
      • Findlay, Ohio, Förenta staterna, 45840
        • Orion Cancer Care
      • Franklin, Ohio, Förenta staterna, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, Förenta staterna, 45005
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, Förenta staterna, 45331
        • Wayne Hospital
      • Greenville, Ohio, Förenta staterna, 45331
        • Dayton Physicians LLC-Wayne
      • Kettering, Ohio, Förenta staterna, 45429
        • Kettering Medical Center
      • Kettering, Ohio, Förenta staterna, 45409
        • Greater Dayton Cancer Center
      • Middletown, Ohio, Förenta staterna, 45042
        • Dayton Physicians LLC-Signal Point
      • Sidney, Ohio, Förenta staterna, 45365
        • Dayton Physicians LLC-Wilson
      • Springfield, Ohio, Förenta staterna, 45505
        • Springfield Regional Medical Center
      • Springfield, Ohio, Förenta staterna, 45504
        • Springfield Regional Cancer Center
      • Troy, Ohio, Förenta staterna, 45373
        • Upper Valley Medical Center
      • Troy, Ohio, Förenta staterna, 45373
        • Dayton Physicians LLC-Upper Valley
    • Oklahoma
      • Tulsa, Oklahoma, Förenta staterna, 74136
        • Surgical Associates Inc
      • Tulsa, Oklahoma, Förenta staterna, 74146
        • Warren Clinic Oncology-Tulsa
    • Oregon
      • Bend, Oregon, Förenta staterna, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, Förenta staterna, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, Förenta staterna, 97015
        • Providence Oncology and Hematology Care Southeast
      • Coos Bay, Oregon, Förenta staterna, 97420
        • Bay Area Hospital
      • Milwaukie, Oregon, Förenta staterna, 97222
        • Providence Milwaukie Hospital
      • Newberg, Oregon, Förenta staterna, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, Förenta staterna, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, Förenta staterna, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Förenta staterna, 97225
        • Providence Saint Vincent Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, Förenta staterna, 17822
        • Geisinger Medical Center
      • Lewistown, Pennsylvania, Förenta staterna, 17044
        • Lewistown Hospital
      • Pittsburgh, Pennsylvania, Förenta staterna, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84112
        • Huntsman Cancer Institute/University of Utah
    • Vermont
      • Berlin Corners, Vermont, Förenta staterna, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, Förenta staterna, 05401
        • University of Vermont Medical Center
      • Burlington, Vermont, Förenta staterna, 05405
        • University of Vermont College of Medicine
    • Virginia
      • Richmond, Virginia, Förenta staterna, 23298
        • Virginia Commonwealth University/Massey Cancer Center
    • Washington
      • Aberdeen, Washington, Förenta staterna, 98520
        • Providence Regional Cancer System-Aberdeen
      • Anacortes, Washington, Förenta staterna, 98221
        • Cancer Care Center at Island Hospital
      • Bellevue, Washington, Förenta staterna, 98005
        • Swedish Cancer Institute-Eastside Oncology Hematology
      • Bellingham, Washington, Förenta staterna, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, Förenta staterna, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, Förenta staterna, 98026
        • Swedish Medical Center-Edmonds
      • Everett, Washington, Förenta staterna, 98201
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, Förenta staterna, 98029
        • Swedish Cancer Institute-Issaquah
      • Lacey, Washington, Förenta staterna, 98503
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, Förenta staterna, 98632
        • PeaceHealth Saint John Medical Center
      • Seattle, Washington, Förenta staterna, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Förenta staterna, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, Förenta staterna, 98195
        • University of Washington Medical Center
      • Seattle, Washington, Förenta staterna, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Förenta staterna, 98104
        • Minor and James Medical PLLC
      • Seattle, Washington, Förenta staterna, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, Förenta staterna, 98112
        • Group Health Cooperative-Seattle
      • Seattle, Washington, Förenta staterna, 98122-4307
        • Swedish Medical Center-First Hill
      • Shelton, Washington, Förenta staterna, 98584
        • Providence Regional Cancer System-Shelton
      • Spokane, Washington, Förenta staterna, 99204
        • Rockwood Cancer Treatment Center-DHEC-Downtown
      • Spokane Valley, Washington, Förenta staterna, 99216
        • Rockwood Clinic Cancer Treatment Center-Valley
      • Vancouver, Washington, Förenta staterna, 98664
        • PeaceHealth Southwest Medical Center
      • Vancouver, Washington, Förenta staterna, 98684
        • Compass Oncology Vancouver
      • Walla Walla, Washington, Förenta staterna, 99362
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, Förenta staterna, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
      • Yelm, Washington, Förenta staterna, 98597
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • La Crosse, Wisconsin, Förenta staterna, 54601
        • Mayo Clinic Health System-Franciscan Healthcare
      • Madison, Wisconsin, Förenta staterna, 53792
        • University of Wisconsin Hospital and Clinics

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 till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

  1. 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.
  2. Other Lymphomas: Patients must have no evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS.
  3. Previous Treatment: Patients must have no prior chemotherapy or radiation therapy for lymphoma.
  4. Age- Patients must be between the ages of 18 and 75 years.
  5. Karnofsky Performance Scale - Patients must measure Karnofsky Performance Scale ≥ 30 (≥ 50 for patients ages 60-70).
  6. 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)
  7. HIV - Patients must have negative HIV serology.
  8. 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.
  9. Organ Transplant or Immunosuppressant Therapy - Patient must have no history of organ transplantation or ongoing immunosuppressant therapy.
  10. 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

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: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Arm I

Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.
Läkemedel: G-CSF
Procedur: stamcellstransplantation
Läkemedel: carmustine

Given IV

Läkemedel: thiotepa

Given IV
Övrig: Arm II

Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.
Läkemedel: G-CSF
Läkemedel: cytarabine

Given IV

Läkemedel: etoposide

Given IV

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression Free Survival
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Event Free Survival
Tidsram: 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
Tidsram: 7 years

Number of patients reporting at least one adverse event at least possibly related to treatment.
7 years
Overall Survival
Tidsram: 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

Samarbetspartners och utredare

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

Sponsor

Alliance for Clinical Trials in Oncology

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Studiestol: Tracy Batchelor, MD, MPH, Massachusetts General Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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

1 september 2012

Primärt slutförande (Faktisk)

14 januari 2021

Avslutad studie (Faktisk)

24 februari 2022

Studieregistreringsdatum

Först inskickad

13 januari 2012

Först inskickad som uppfyllde QC-kriterierna

13 januari 2012

Första postat (Beräknad)

18 januari 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CALGB-51101
  • CDR0000721927 (Registeridentifierare: NCI Physician Data Query)
  • NCI-2012-00110 (Registeridentifierare: NCI Clinical Trial Reporting Program)

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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