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



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 75
Updated:1/26/2019
Start Date:September 2012

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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.

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)

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
We found this trial at
126
sites
200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Tracy T. Batchelor
Phone: 877-726-5130
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
Principal Investigator: Julian R. Sprague
Phone: 802-656-4101
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Principal Investigator: Beata Holkova
Phone: 804-628-1939
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Jonathan W. Friedberg
Phone: 585-275-5830
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Principal Investigator: Frederick R. Appelbaum
Phone: 800-422-6237
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Frederick R. Appelbaum
Phone: 800-422-6237
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Seattle, Washington 98104
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
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808 North 39th Avenue
Yakima, Washington 98902
Principal Investigator: Keith S. Lanier
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Aberdeen, Washington 98520
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Anacortes, Washington 98221
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 98508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99504
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99508
Principal Investigator: Keith S. Lanier
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
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Anchorage, Alaska 99508
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Atlanta, Georgia 30322
Principal Investigator: Jonathon B. Cohen
Phone: 404-778-1868
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Lode J. Swinnen
Phone: 410-955-8804
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
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Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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Bellevue, Washington 98005
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Bend, Oregon 97701
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
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Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Tracy T. Batchelor
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Massachusetts General Hospital Cancer Center An integral part of one of the world
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Tracy T. Batchelor
Phone: 877-726-5130
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Burbank, California
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Burlington, Vermont 05405
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Centerville, Ohio 45459
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Centralia, Washington 98531
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
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Phone: 312-355-3046
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
Principal Investigator: Kenneth S. Cohen
Phone: 773-834-7424
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Cincinnati, Ohio 45236
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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Clackamas, Oregon 97015
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Coos Bay, Oregon 97420
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Crestview Hills, Kentucky 41017
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Edward J. Gorak
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
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Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Dayton, Ohio 45420
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2222 Philadelphia Dr
Dayton, Ohio 45406
(937) 734-2612
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Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
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9000 N. Main St.
Dayton, Ohio 45415
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Samaritan North Health Center Good Samaritan Hospital (GSH) is passionate about providing the most recent...
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Dayton, Ohio 45415
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Jeffrey Crawford
Phone: 888-275-3853
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Edmonds, Washington 98026
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1717 13th St
Everett, Washington 98201
(425) 297-5500
Principal Investigator: Alison K. Conlin
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Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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Findlay, Ohio 45840
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1900 S Main St
Findlay, Ohio 45840
(419) 423-4500
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Blanchard Valley Hospital For more than 100 years, Blanchard Valley Hospital has made quality care...
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Findlay, Ohio 45840
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One Medical Center Drive
Franklin, Ohio 45005
(513) 424-2111
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Franklin, Ohio 45005
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Fruitland, Idaho 83619
Principal Investigator: Alison K. Conlin
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Grand Rapids, Michigan 49503
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
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100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Principal Investigator: Kathleen J. Yost
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Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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835 Sweitzer St
Greenville, Ohio 45331
(937) 548-1141
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Wayne Hospital Stretching back to our roots nearly 100 years ago, Wayne HealthCare has always...
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Greenville, Ohio 45331
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Issaquah, Washington 98029
Principal Investigator: Alison K. Conlin
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1521 Gull Rd
Kalamazoo, Michigan 49048
269) 226-7000
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
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Kansas City, Kansas 66160
Principal Investigator: Leyla Shune
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3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
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Kettering, Ohio 45409
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La Crosse, Wisconsin 54601
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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Lacey, Washington 98503
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400 Highland Ave
Lewistown, Pennsylvania 17044
(717) 248-5411
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Longview, Washington 98632
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Julie E. Chang
Phone: 877-405-6866
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Meridian, Idaho 83642
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Middletown, Ohio 45042
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10150 SE 32nd Ave
Milwaukie, Oregon 97222
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Muskegon, Michigan 49444
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Nampa, Idaho 83686
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New Haven, Connecticut 6520
(203) 432-4771
Phone: 203-785-7284
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
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Phone: 504-988-6121
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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445 E 69th St
New York, New York 10021
(212) 746-1067
Principal Investigator: Jia Ruan
Phone: 212-746-1848
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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1001 Providence Dr
Newberg, Oregon 97132
(503) 537-1555
Principal Investigator: Alison K. Conlin
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Providence Newberg Medical Center Providence Health & Services in Oregon, ranked as one of the...
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Niles, Michigan 49120
Principal Investigator: Kathleen J. Yost
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Philip J. Bierman
Phone: 402-559-6941
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Oregon City, Oregon 97045
Principal Investigator: Alison K. Conlin
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Jan Drappatz
Phone: 412-647-8073
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Portland, Oregon 97225
Principal Investigator: Alison K. Conlin
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300 N Patterson Rd
Reed City, Michigan 49677
(231) 832-3271
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
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Richmond, Indiana 47374
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Rochester, Minnesota 55905
Principal Investigator: Patrick B. Johnston
Phone: 855-776-0015
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Sacramento, California 95817
Principal Investigator: Mehrdad Abedi
Phone: 916-734-3089
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Saint Joseph, Michigan 49085
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
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3900 Hollywood Road
Saint Joseph, Michigan 49085
(269) 428-4411
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Marie Yeager Cancer Center The Marie Yeager Cancer Center is located at the Lakeland Health...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Nancy L. Bartlett
Phone: 800-600-3606
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Principal Investigator: Adam L. Cohen
Phone: 801-581-4477
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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San Francisco, California 94143
Principal Investigator: James L. Rubenstein
Phone: 877-827-3222
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San Francisco, California 94115
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