Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma
- Conditions
- Lymphoma
- Interventions
- Procedure: stem cell transplant
- Registration Number
- NCT01511562
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- Detailed Description
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)
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 113
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I carmustine Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant. Arm I stem cell transplant Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant. Arm I G-CSF Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant. Arm II cytarabine Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy. Arm II etoposide Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy. Arm II G-CSF Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy. Arm I thiotepa Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.
- Primary Outcome Measures
Name Time Method progression free survival Up to 10 years
- Secondary Outcome Measures
Name Time Method event free survival Up to 10 years number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Up to 10 years overall survival Up to 10 years
Trial Locations
- Locations (126)
University of Pittsburgh Cancer Institute (UPCI)
🇺🇸Pittsburgh, Pennsylvania, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Pacific Gynecology Specialists
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Oncology Hematology Care Inc-Eden Park
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care Inc - Anderson
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Blue Ash
🇺🇸Cincinnati, Ohio, United States
Katmai Oncology Group
🇺🇸Anchorage, Alaska, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
🇺🇸Burbank, California, United States
Bronson Battle Creek
🇺🇸Battle Creek, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Emory University/Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Saint Luke's Mountain States Tumor Institute-Twin Falls
🇺🇸Twin Falls, Idaho, United States
Reid Health
🇺🇸Richmond, Indiana, United States
Oncology Hematology Care Inc-Crestview
🇺🇸Crestview Hills, Kentucky, United States
Alaska Oncology and Hematology LLC
🇺🇸Anchorage, Alaska, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
University of Illinois
🇺🇸Chicago, Illinois, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Saint Luke's Mountain States Tumor Institute - Meridian
🇺🇸Meridian, Idaho, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Anchorage Associates in Radiation Medicine
🇺🇸Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
🇺🇸Anchorage, Alaska, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Alaska Women's Cancer Care
🇺🇸Anchorage, Alaska, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
🇺🇸Baltimore, Maryland, United States
University of Chicago Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
University of Kansas Cancer Center
🇺🇸Kansas City, Kansas, United States
Spectrum Health at Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Lakeland Hospital
🇺🇸Saint Joseph, Michigan, United States
Saint Luke's Mountain States Tumor Institute - Fruitland
🇺🇸Fruitland, Idaho, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
Blanchard Valley Hospital
🇺🇸Findlay, Ohio, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
State University of New York Upstate Medical University
🇺🇸Syracuse, New York, United States
Dayton Physicians LLC-Wayne
🇺🇸Greenville, Ohio, United States
Oncology Hematology Care Inc-Mercy West
🇺🇸Cincinnati, Ohio, United States
Mercy Health Saint Mary's
🇺🇸Grand Rapids, Michigan, United States
Surgical Associates Inc
🇺🇸Tulsa, Oklahoma, United States
Dayton Physicians LLC-Samaritan North
🇺🇸Dayton, Ohio, United States
Lakeland Community Hospital
🇺🇸Niles, Michigan, United States
Atrium Medical Center-Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
Bay Area Hospital
🇺🇸Coos Bay, Oregon, United States
University of Rochester
🇺🇸Rochester, New York, United States
Armes Family Cancer Center
🇺🇸Findlay, Ohio, United States
Oncology Hematology Care Inc-Healthplex
🇺🇸Fairfield, Ohio, United States
Providence Oncology and Hematology Care Southeast
🇺🇸Clackamas, Oregon, United States
Dayton Physicians LLC-Wilson
🇺🇸Sidney, Ohio, United States
Lewistown Hospital
🇺🇸Lewistown, Pennsylvania, United States
Clackamas Radiation Oncology Center
🇺🇸Clackamas, Oregon, United States
PeaceHealth Saint John Medical Center
🇺🇸Longview, Washington, United States
Dayton Physicians LLC-Miami Valley South
🇺🇸Centerville, Ohio, United States
Springfield Regional Medical Center
🇺🇸Springfield, Ohio, United States
Samaritan North Health Center
🇺🇸Dayton, Ohio, United States
Orion Cancer Care
🇺🇸Findlay, Ohio, United States
Swedish Cancer Institute-Eastside Oncology Hematology
🇺🇸Bellevue, Washington, United States
Greater Dayton Cancer Center
🇺🇸Kettering, Ohio, United States
Saint Charles Health System
🇺🇸Bend, Oregon, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
University of Vermont College of Medicine
🇺🇸Burlington, Vermont, United States
Providence Regional Cancer System-Aberdeen
🇺🇸Aberdeen, Washington, United States
Providence Regional Cancer Partnership
🇺🇸Everett, Washington, United States
Providence Newberg Medical Center
🇺🇸Newberg, Oregon, United States
Swedish Medical Center-Edmonds
🇺🇸Edmonds, Washington, United States
PeaceHealth Saint Joseph Medical Center
🇺🇸Bellingham, Washington, United States
Mayo Clinic Health System-Franciscan Healthcare
🇺🇸La Crosse, Wisconsin, United States
Providence Regional Cancer System-Centralia
🇺🇸Centralia, Washington, United States
Central Vermont Medical Center/National Life Cancer Treatment
🇺🇸Berlin, Vermont, United States
PeaceHealth Southwest Medical Center
🇺🇸Vancouver, Washington, United States
Providence Regional Cancer System-Shelton
🇺🇸Shelton, Washington, United States
UCSF Medical Center-Mount Zion
🇺🇸San Francisco, California, United States
UCSF Medical Center-Parnassus
🇺🇸San Francisco, California, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Providence Saint Vincent Medical Center
🇺🇸Portland, Oregon, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Huntsman Cancer Institute/University of Utah
🇺🇸Salt Lake City, Utah, United States
Warren Clinic Oncology-Tulsa
🇺🇸Tulsa, Oklahoma, United States
Group Health Cooperative-Seattle
🇺🇸Seattle, Washington, United States
Swedish Medical Center-First Hill
🇺🇸Seattle, Washington, United States
Cancer Care Center at Island Hospital
🇺🇸Anacortes, Washington, United States
Swedish Cancer Institute-Issaquah
🇺🇸Issaquah, Washington, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Minor and James Medical PLLC
🇺🇸Seattle, Washington, United States
Swedish Medical Center-Ballard Campus
🇺🇸Seattle, Washington, United States
Rockwood Clinic Cancer Treatment Center-Valley
🇺🇸Spokane Valley, Washington, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Mercy Health Mercy Campus
🇺🇸Muskegon, Michigan, United States
Spectrum Health Reed City Hospital
🇺🇸Reed City, Michigan, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
Marie Yeager Cancer Center
🇺🇸Saint Joseph, Michigan, United States
Providence Regional Cancer System-Lacey
🇺🇸Lacey, Washington, United States
Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Rockwood Cancer Treatment Center-DHEC-Downtown
🇺🇸Spokane, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States
Providence Regional Cancer System-Yelm
🇺🇸Yelm, Washington, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Anchorage Oncology Centre
🇺🇸Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
🇺🇸Anchorage, Alaska, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Saint Luke's Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Nampa
🇺🇸Nampa, Idaho, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Oncology Hematology Care Inc-Kenwood
🇺🇸Cincinnati, Ohio, United States
Good Samaritan Hospital - Dayton
🇺🇸Dayton, Ohio, United States
Dayton NCI Community Oncology Research Program
🇺🇸Dayton, Ohio, United States
Springfield Regional Cancer Center
🇺🇸Springfield, Ohio, United States
Dayton Physicians LLC-Atrium
🇺🇸Franklin, Ohio, United States
Wayne Hospital
🇺🇸Greenville, Ohio, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Dayton Physicians LLC-Signal Point
🇺🇸Middletown, Ohio, United States
Dayton Physicians LLC-Upper Valley
🇺🇸Troy, Ohio, United States
Providence Willamette Falls Medical Center
🇺🇸Oregon City, Oregon, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Providence Saint Mary Regional Cancer Center
🇺🇸Walla Walla, Washington, United States
Compass Oncology Vancouver
🇺🇸Vancouver, Washington, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
University of California Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States