Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01511562
Recruitment Status : Active, not recruiting
First Posted : January 18, 2012
Last Update Posted : January 24, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: carmustine Drug: cytarabine Drug: etoposide Drug: thiotepa Procedure: stem cell transplant Drug: G-CSF Phase 2

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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Myeloablative Versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-cell Lymphoma
Study Start Date : September 2012
Estimated Primary Completion Date : October 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Arm I
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.
Drug: carmustine
Given IV

Drug: thiotepa
Given IV

Procedure: stem cell transplant
Drug: G-CSF
Arm II
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.
Drug: cytarabine
Given IV

Drug: etoposide
Given IV

Drug: G-CSF



Primary Outcome Measures :
  1. progression free survival [ Time Frame: Up to 10 years ]

Secondary Outcome Measures :
  1. event free survival [ Time Frame: Up to 10 years ]
  2. number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 10 years ]
  3. overall survival [ Time Frame: Up to 10 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511562


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

Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01511562     History of Changes
Other Study ID Numbers: CALGB-51101
CALGB-51101
CDR0000721927 ( Registry Identifier: NCI Physician Data Query )
NCI-2012-00110 ( Registry Identifier: NCI Clinical Trial Reporting Program )
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Keywords provided by Alliance for Clinical Trials in Oncology:
primary central nervous system non-Hodgkin lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
stage I adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cytarabine
Etoposide
Thiotepa
Carmustine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists