LymphomaPhase 2NCT01511562
Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma
A Phase 2 study testing carmustine, cytarabine and etoposide in people with Lymphoma, run by Alliance for Clinical Trials in Oncology at 126 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- carmustine, cytarabine and etoposide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 126 sitesUnited States
- Study dates
- Sep 2012to 24 Feb 2022
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
126 sites in 1 country.
126 sites in 1 country
United States126 sites
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Anchorage Oncology Centre
Anchorage, Alaska, 99508
Katmai Oncology Group
Anchorage, Alaska, 99508
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Bronson Battle Creek
Battle Creek, Michigan, 49017
Swedish Cancer Institute-Eastside Oncology Hematology
Bellevue, Washington, 98005
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Saint Charles Health System
Bend, Oregon, 97701
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
University of Vermont Medical Center
Burlington, Vermont, 05401
University of Vermont College of Medicine
Burlington, Vermont, 05405
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
University of Illinois
Chicago, Illinois, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, 45202
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, 45211
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, 45230
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, 45242
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Providence Oncology and Hematology Care Southeast
Clackamas, Oregon, 97015
Bay Area Hospital
Coos Bay, Oregon, 97420
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, 41017
Geisinger Medical Center
Danville, Pennsylvania, 17822
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
Miami Valley Hospital
Dayton, Ohio, 45409
Dayton Physicians LLC-Samaritan North
Dayton, Ohio, 45415
Samaritan North Health Center
Dayton, Ohio, 45415
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45420
Duke University Medical Center
Durham, North Carolina, 27710
Swedish Medical Center-Edmonds
Edmonds, Washington, 98026
Providence Regional Cancer Partnership
Everett, Washington, 98201
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, 45014
Armes Family Cancer Center
Findlay, Ohio, 45840
Blanchard Valley Hospital
Findlay, Ohio, 45840
Orion Cancer Care
Findlay, Ohio, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, 83619
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
Wayne Hospital
Greenville, Ohio, 45331
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Borgess Medical Center
Kalamazoo, Michigan, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Greater Dayton Cancer Center
Kettering, Ohio, 45409
Kettering Medical Center
Kettering, Ohio, 45429
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Lewistown Hospital
Lewistown, Pennsylvania, 17044
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, 83642
Dayton Physicians LLC-Signal Point
Middletown, Ohio, 45042
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222
Mercy Health Mercy Campus
Muskegon, Michigan, 49444
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, 83686
Yale University
New Haven, Connecticut, 06520
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Weill Medical College of Cornell University
New York, New York, 10065
Providence Newberg Medical Center
Newberg, Oregon, 97132
Lakeland Community Hospital
Niles, Michigan, 49120
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677
Reid Health
Richmond, Indiana, 47374
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Lakeland Hospital
Saint Joseph, Michigan, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
UCSF Medical Center-Mount Zion
San Francisco, California, 94115
UCSF Medical Center-Parnassus
San Francisco, California, 94143
Minor and James Medical PLLC
Seattle, Washington, 98104
Pacific Gynecology Specialists
Seattle, Washington, 98104
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Group Health Cooperative-Seattle
Seattle, Washington, 98112
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307
University of Washington Medical Center
Seattle, Washington, 98195
Providence Regional Cancer System-Shelton
Shelton, Washington, 98584
Dayton Physicians LLC-Wilson
Sidney, Ohio, 45365
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane, Washington, 99204
Rockwood Clinic Cancer Treatment Center-Valley
Spokane Valley, Washington, 99216
Springfield Regional Cancer Center
Springfield, Ohio, 45504
Springfield Regional Medical Center
Springfield, Ohio, 45505
Washington University School of Medicine
St Louis, Missouri, 63110
Stony Brook University Medical Center
Stony Brook, New York, 11794
State University of New York Upstate Medical University
Syracuse, New York, 13210
Moffitt Cancer Center
Tampa, Florida, 33612
Munson Medical Center
Traverse City, Michigan, 49684
Dayton Physicians LLC-Upper Valley
Troy, Ohio, 45373
Upper Valley Medical Center
Troy, Ohio, 45373
Surgical Associates Inc
Tulsa, Oklahoma, 74136
Warren Clinic Oncology-Tulsa
Tulsa, Oklahoma, 74146
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, 83301
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
Compass Oncology Vancouver
Vancouver, Washington, 98684
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362
Metro Health Hospital
Wyoming, Michigan, 49519
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902
Providence Regional Cancer System-Yelm
Yelm, Washington, 98597
About this study
Official title: A Randomized Phase II Trial of Myeloablative Versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-cell Lymphoma
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.
Read the 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:
- 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)
- Conditions
- Lymphoma
- Being tested
- carmustine, cytarabine, etoposide, thiotepa, stem cell transplant
- Keywords
- 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
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carmustineDrug
Given IV
cytarabineDrug
Given IV
etoposideDrug
Given IV
thiotepaDrug
Given IV
stem cell transplantProcedure or surgery
G-CSFDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Other | Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant. Receives: Drug: carmustine; Drug: thiotepa; Procedure: stem cell transplant; Drug: G-CSF |
| Arm II | Other | Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy. Receives: Drug: cytarabine; Drug: etoposide; Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
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.
Measured: 2 years
Secondary outcomes (3)
Event Free Survival
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
Measured: 2 years
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Number of patients reporting at least one adverse event at least possibly related to treatment.
Measured: 7 years
Overall Survival
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startSep 2012
- Primary completion14 Jan 2021
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tracy Batchelor, MD, MPH, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511562
- Sponsor's protocol ID
- CALGB-51101
- Other IDs
- CALGB-51101, CDR0000721927, NCI-2012-00110
- Status last verified
- Aug 2026
- First submitted
- 13 Jan 2012
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Batchelor TT, Giri S, Ruppert AS, Geyer SM, Smith SE, Mohile N, Swinnen LJ, Friedberg JW, Kahl BS, Bartlett NL, Hsi ED, Cheson BD, Wagner-Johnston N, Nayak L, Leonard JP, Rubenstein JL. Myeloablative vs nonmyeloablative consolidation for primary central nervous system lymphoma: results of Alliance 51101. Blood Adv. 2024 Jun 25;8(12):3189-3199. doi: 10.1182/bloodadvances.2023011657.
PubMed 38598710