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Combinatiechemotherapie met of zonder autologe stamceltransplantatie bij de behandeling van patiënten met B-cellymfoom van het centrale zenuwstelsel

31 augustus 2026 bijgewerkt door: Alliance for Clinical Trials in Oncology

Een gerandomiseerde fase II-studie van myeloablatieve versus niet-myeloablatieve consolidatiechemotherapie voor nieuw gediagnosticeerd primair CZS-B-cellymfoom

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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)

Studietype

Ingrijpend

Inschrijving (Werkelijk)

113

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Alaska
      • Anchorage, Alaska, Verenigde Staten, 98508
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Providence Alaska Medical Center
      • Anchorage, Alaska, Verenigde Staten, 99504
        • Anchorage Radiation Therapy Center
    • California
      • Burbank, California, Verenigde Staten, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • La Jolla, California, Verenigde Staten, 92093
        • UC San Diego Moores Cancer Center
      • Sacramento, California, Verenigde Staten, 95817
        • University of California Davis Comprehensive Cancer Center
      • San Francisco, California, Verenigde Staten, 94115
        • UCSF Medical Center-Mount Zion
      • San Francisco, California, Verenigde Staten, 94143
        • UCSF Medical Center-Parnassus
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06520
        • Yale University
    • Florida
      • Tampa, Florida, Verenigde Staten, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30322
        • Emory University/Winship Cancer Institute
    • Idaho
      • Boise, Idaho, Verenigde Staten, 83712
        • Saint Luke's Mountain States Tumor Institute
      • Fruitland, Idaho, Verenigde Staten, 83619
        • Saint Luke's Mountain States Tumor Institute - Fruitland
      • Meridian, Idaho, Verenigde Staten, 83642
        • Saint Luke's Mountain States Tumor Institute - Meridian
      • Nampa, Idaho, Verenigde Staten, 83686
        • Saint Luke's Mountain States Tumor Institute - Nampa
      • Twin Falls, Idaho, Verenigde Staten, 83301
        • Saint Luke's Mountain States Tumor Institute-Twin Falls
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Verenigde Staten, 60612
        • University of Illinois
    • Indiana
      • Richmond, Indiana, Verenigde Staten, 47374
        • Reid Health
    • Kansas
      • Kansas City, Kansas, Verenigde Staten, 66160
        • University of Kansas Cancer Center
    • Kentucky
      • Crestview Hills, Kentucky, Verenigde Staten, 41017
        • Oncology Hematology Care Inc-Crestview
    • Louisiana
      • New Orleans, Louisiana, Verenigde Staten, 70112
        • Tulane University Health Sciences Center
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Battle Creek, Michigan, Verenigde Staten, 49017
        • Bronson Battle Creek
      • Grand Rapids, Michigan, Verenigde Staten, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, Verenigde Staten, 49503
        • Mercy Health Saint Mary's
      • Kalamazoo, Michigan, Verenigde Staten, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Verenigde Staten, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Verenigde Staten, 49001
        • Borgess Medical Center
      • Muskegon, Michigan, Verenigde Staten, 49444
        • Mercy Health Mercy Campus
      • Niles, Michigan, Verenigde Staten, 49120
        • Lakeland Community Hospital
      • Reed City, Michigan, Verenigde Staten, 49677
        • Spectrum Health Reed City Hospital
      • Saint Joseph, Michigan, Verenigde Staten, 49085
        • Marie Yeager Cancer Center
      • Saint Joseph, Michigan, Verenigde Staten, 49085
        • Lakeland Hospital
      • Traverse City, Michigan, Verenigde Staten, 49684
        • Munson Medical Center
      • Wyoming, Michigan, Verenigde Staten, 49519
        • Metro Health Hospital
    • Minnesota
      • Rochester, Minnesota, Verenigde Staten, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, Verenigde Staten, 68198
        • University of Nebraska Medical Center
    • New York
      • New York, New York, Verenigde Staten, 10065
        • Weill Medical College of Cornell University
      • Rochester, New York, Verenigde Staten, 14642
        • University of Rochester
      • Stony Brook, New York, Verenigde Staten, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, Verenigde Staten, 13210
        • State University of New York Upstate Medical University
    • North Carolina
      • Durham, North Carolina, Verenigde Staten, 27710
        • Duke University Medical Center
    • Ohio
      • Centerville, Ohio, Verenigde Staten, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Cincinnati, Ohio, Verenigde Staten, 45242
        • Oncology Hematology Care Inc-Blue Ash
      • Cincinnati, Ohio, Verenigde Staten, 45202
        • Oncology Hematology Care Inc-Eden Park
      • Cincinnati, Ohio, Verenigde Staten, 45211
        • Oncology Hematology Care Inc-Mercy West
      • Cincinnati, Ohio, Verenigde Staten, 45236
        • Oncology Hematology Care Inc-Kenwood
      • Cincinnati, Ohio, Verenigde Staten, 45230
        • Oncology Hematology Care Inc - Anderson
      • Dayton, Ohio, Verenigde Staten, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, Verenigde Staten, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Verenigde Staten, 45415
        • Dayton Physicians LLC-Samaritan North
      • Dayton, Ohio, Verenigde Staten, 45415
        • Samaritan North Health Center
      • Dayton, Ohio, Verenigde Staten, 45420
        • Dayton NCI Community Oncology Research Program
      • Fairfield, Ohio, Verenigde Staten, 45014
        • Oncology Hematology Care Inc-Healthplex
      • Findlay, Ohio, Verenigde Staten, 45840
        • Blanchard Valley Hospital
      • Findlay, Ohio, Verenigde Staten, 45840
        • Armes Family Cancer Center
      • Findlay, Ohio, Verenigde Staten, 45840
        • Orion Cancer Care
      • Franklin, Ohio, Verenigde Staten, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, Verenigde Staten, 45005
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, Verenigde Staten, 45331
        • Wayne Hospital
      • Greenville, Ohio, Verenigde Staten, 45331
        • Dayton Physicians LLC-Wayne
      • Kettering, Ohio, Verenigde Staten, 45429
        • Kettering Medical Center
      • Kettering, Ohio, Verenigde Staten, 45409
        • Greater Dayton Cancer Center
      • Middletown, Ohio, Verenigde Staten, 45042
        • Dayton Physicians LLC-Signal Point
      • Sidney, Ohio, Verenigde Staten, 45365
        • Dayton Physicians LLC-Wilson
      • Springfield, Ohio, Verenigde Staten, 45505
        • Springfield Regional Medical Center
      • Springfield, Ohio, Verenigde Staten, 45504
        • Springfield Regional Cancer Center
      • Troy, Ohio, Verenigde Staten, 45373
        • Upper Valley Medical Center
      • Troy, Ohio, Verenigde Staten, 45373
        • Dayton Physicians LLC-Upper Valley
    • Oklahoma
      • Tulsa, Oklahoma, Verenigde Staten, 74136
        • Surgical Associates Inc
      • Tulsa, Oklahoma, Verenigde Staten, 74146
        • Warren Clinic Oncology-Tulsa
    • Oregon
      • Bend, Oregon, Verenigde Staten, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, Verenigde Staten, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, Verenigde Staten, 97015
        • Providence Oncology and Hematology Care Southeast
      • Coos Bay, Oregon, Verenigde Staten, 97420
        • Bay Area Hospital
      • Milwaukie, Oregon, Verenigde Staten, 97222
        • Providence Milwaukie Hospital
      • Newberg, Oregon, Verenigde Staten, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, Verenigde Staten, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, Verenigde Staten, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Verenigde Staten, 97225
        • Providence Saint Vincent Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, Verenigde Staten, 17822
        • Geisinger Medical Center
      • Lewistown, Pennsylvania, Verenigde Staten, 17044
        • Lewistown Hospital
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84112
        • Huntsman Cancer Institute/University of Utah
    • Vermont
      • Berlin Corners, Vermont, Verenigde Staten, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, Verenigde Staten, 05401
        • University of Vermont Medical Center
      • Burlington, Vermont, Verenigde Staten, 05405
        • University of Vermont College of Medicine
    • Virginia
      • Richmond, Virginia, Verenigde Staten, 23298
        • Virginia Commonwealth University/Massey Cancer Center
    • Washington
      • Aberdeen, Washington, Verenigde Staten, 98520
        • Providence Regional Cancer System-Aberdeen
      • Anacortes, Washington, Verenigde Staten, 98221
        • Cancer Care Center at Island Hospital
      • Bellevue, Washington, Verenigde Staten, 98005
        • Swedish Cancer Institute-Eastside Oncology Hematology
      • Bellingham, Washington, Verenigde Staten, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, Verenigde Staten, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, Verenigde Staten, 98026
        • Swedish Medical Center-Edmonds
      • Everett, Washington, Verenigde Staten, 98201
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, Verenigde Staten, 98029
        • Swedish Cancer Institute-Issaquah
      • Lacey, Washington, Verenigde Staten, 98503
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, Verenigde Staten, 98632
        • PeaceHealth Saint John Medical Center
      • Seattle, Washington, Verenigde Staten, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Verenigde Staten, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, Verenigde Staten, 98195
        • University of Washington Medical Center
      • Seattle, Washington, Verenigde Staten, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Verenigde Staten, 98104
        • Minor and James Medical PLLC
      • Seattle, Washington, Verenigde Staten, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, Verenigde Staten, 98112
        • Group Health Cooperative-Seattle
      • Seattle, Washington, Verenigde Staten, 98122-4307
        • Swedish Medical Center-First Hill
      • Shelton, Washington, Verenigde Staten, 98584
        • Providence Regional Cancer System-Shelton
      • Spokane, Washington, Verenigde Staten, 99204
        • Rockwood Cancer Treatment Center-DHEC-Downtown
      • Spokane Valley, Washington, Verenigde Staten, 99216
        • Rockwood Clinic Cancer Treatment Center-Valley
      • Vancouver, Washington, Verenigde Staten, 98664
        • PeaceHealth Southwest Medical Center
      • Vancouver, Washington, Verenigde Staten, 98684
        • Compass Oncology Vancouver
      • Walla Walla, Washington, Verenigde Staten, 99362
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, Verenigde Staten, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
      • Yelm, Washington, Verenigde Staten, 98597
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • La Crosse, Wisconsin, Verenigde Staten, 54601
        • Mayo Clinic Health System-Franciscan Healthcare
      • Madison, Wisconsin, Verenigde Staten, 53792
        • University of Wisconsin Hospital and Clinics

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

  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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Arm I

Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.
Geneesmiddel: G-CSF
Procedure: stamcel transplantatie
Geneesmiddel: carmustine

Given IV

Geneesmiddel: thiotepa

Given IV
Ander: Arm II

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

Given IV

Geneesmiddel: etoposide

Given IV

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression Free Survival
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Event Free Survival
Tijdsspanne: 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
Tijdsspanne: 7 years

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Alliance for Clinical Trials in Oncology

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Studie stoel: Tracy Batchelor, MD, MPH, Massachusetts General Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2012

Primaire voltooiing (Werkelijk)

14 januari 2021

Studie voltooiing (Werkelijk)

24 februari 2022

Studieregistratiedata

Eerst ingediend

13 januari 2012

Eerst ingediend dat voldeed aan de QC-criteria

13 januari 2012

Eerst geplaatst (Geschat)

18 januari 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 september 2026

Laatste update ingediend die voldeed aan QC-criteria

31 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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