⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for S0601 Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: S0601 Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

Official Title: A Phase II Study of Combination Rituximab-CHOP and Bortezomib (Velcade®) (R-CHOP-V) Induction Therapy Followed by Bortezomib Maintenance (VM) Therapy for Patients With Newly Diagnosed Mantle Cell Lymphoma

Study ID: NCT00376961

Conditions

Lymphoma

Study Description

Brief Summary: RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and bortezomib may kill more cancer cells. Giving bortezomib as maintenance therapy may keep the cancer from progressing. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib followed by bortezomib alone works in treating patients with newly diagnosed mantle cell lymphoma.

Detailed Description: OBJECTIVES: Primary * Determine the 2-year progression-free survival rate in patients with newly diagnosed mantle cell lymphoma treated with induction therapy comprising rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and bortezomib followed by bortezomib maintenance (VM) therapy. Secondary * Determine the response rate (complete, complete unconfirmed, and partial responses) in patients treated with this regimen. * Determine the toxicity of VM in these patients. OUTLINE: This is a multicenter study. * Induction therapy: Patients receive R-CHOP-V induction therapy comprising rituximab IV over ≤ 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin hydrochloride IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1; oral prednisone once daily on days 1-5; and bortezomib IV over 30-90 minutes on days 1 and 4. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable disease or better proceed to bortezomib maintenance therapy. * Maintenance therapy: Beginning 3 months after completion of R-CHOP-V induction therapy, patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 3 months for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 4 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Alaska Regional Hospital Cancer Center, Anchorage, Alaska, United States

Providence Cancer Center, Anchorage, Alaska, United States

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States

North Bay Cancer Center, Fairfield, California, United States

Poudre Valley Hospital, Fort Collins, Colorado, United States

Broward General Medical Center Cancer Center, Fort Lauderdale, Florida, United States

M.D. Anderson Cancer Center at Orlando, Orlando, Florida, United States

Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise, Idaho, United States

Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States

St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana, United States

Reid Hospital & Health Care Services, Richmond, Indiana, United States

Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States

Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States

Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States

Southwest Medical Center, Liberal, Kansas, United States

Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States

Olathe Cancer Center, Olathe, Kansas, United States

Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States

Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States

Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States

Tammy Walker Cancer Center at Salina Regional Health Center, Salina, Kansas, United States

Cotton-O'Neil Cancer Center, Topeka, Kansas, United States

St. Francis Comprehensive Cancer Center, Topeka, Kansas, United States

Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States

Associates in Womens Health, PA - North Review, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States

CCOP - Wichita, Wichita, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States

Boston University Cancer Research Center, Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, United States

Mecosta County Medical Center, Big Rapids, Michigan, United States

Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States

CCOP - Grand Rapids, Grand Rapids, Michigan, United States

Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States

Metro Health Hospital, Grand Rapids, Michigan, United States

Holland Community Hospital, Holland, Michigan, United States

Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan, United States

Hackley Hospital, Muskegon, Michigan, United States

Munson Medical Center, Traverse City, Michigan, United States

University of Mississippi Cancer Clinic, Jackson, Mississippi, United States

CCOP - Kansas City, Kansas City, Missouri, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States

St. John's Regional Health Center, Springfield, Missouri, United States

Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States

CCOP - Montana Cancer Consortium, Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States

Northern Rockies Radiation Oncology Center, Billings, Montana, United States

St. Vincent Healthcare Cancer Care Services, Billings, Montana, United States

Billings Clinic - Downtown, Billings, Montana, United States

Bozeman Deaconess Cancer Center, Bozeman, Montana, United States

St. James Healthcare Cancer Care, Butte, Montana, United States

Big Sky Oncology, Great Falls, Montana, United States

Great Falls Clinic - Main Facility, Great Falls, Montana, United States

Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States

, Great Falls, Montana, United States

St. Peter's Hospital, Helena, Montana, United States

Glacier Oncology, PLLC, Kalispell, Montana, United States

Kalispell Medical Oncology at KRMC, Kalispell, Montana, United States

Kalispell Regional Medical Center, Kalispell, Montana, United States

Community Medical Center, Missoula, Montana, United States

Guardian Oncology and Center for Wellness, Missoula, Montana, United States

Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States

Good Samaritan Cancer Center at Good Samaritan Hospital, Kearney, Nebraska, United States

Adirondack Cancer Care - Glens Falls, Glens Falls, New York, United States

Tucker Center for Cancer Care at Orange Regional Medical Center, Middletown, New York, United States

Interlakes Oncology/Hematology PC, Rochester, New York, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States

Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States

Pardee Memorial Hospital, Hendersonville, North Carolina, United States

Rutherford Hospital, Rutherfordton, North Carolina, United States

Mary Rutan Hospital, Bellefontaine, Ohio, United States

Adena Regional Medical Center, Chillicothe, Ohio, United States

Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States

Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States

CCOP - Columbus, Columbus, Ohio, United States

Grant Medical Center Cancer Care, Columbus, Ohio, United States

Mount Carmel Health - West Hospital, Columbus, Ohio, United States

Doctors Hospital at Ohio Health, Columbus, Ohio, United States

Grandview Hospital, Dayton, Ohio, United States

Good Samaritan Hospital, Dayton, Ohio, United States

David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States

Samaritan North Cancer Care Center, Dayton, Ohio, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States

CCOP - Dayton, Dayton, Ohio, United States

Grady Memorial Hospital, Delaware, Ohio, United States

Blanchard Valley Medical Associates, Findlay, Ohio, United States

Middletown Regional Hospital, Franklin, Ohio, United States

Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States

Fairfield Medical Center, Lancaster, Ohio, United States

Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States

Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States

Mercy Medical Center, Springfield, Ohio, United States

Community Hospital of Springfield and Clark County, Springfield, Ohio, United States

UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States

Mount Carmel St. Ann's Cancer Center, Westerville, Ohio, United States

Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States

Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States

Legacy Mount Hood Medical Center, Gresham, Oregon, United States

Providence Milwaukie Hospital, Milwaukie, Oregon, United States

Legacy Good Samaritan Hospital & Comprehensive Cancer Center, Portland, Oregon, United States

Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States

Adventist Medical Center, Portland, Oregon, United States

CCOP - Columbia River Oncology Program, Portland, Oregon, United States

Providence St. Vincent Medical Center, Portland, Oregon, United States

Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon, United States

Legacy Meridian Park Hospital, Tualatin, Oregon, United States

AnMed Cancer Center, Anderson, South Carolina, United States

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center, Kingsport, Tennessee, United States

CCOP - Scott and White Hospital, Temple, Texas, United States

American Fork Hospital, American Fork, Utah, United States

Sandra L. Maxwell Cancer Center, Cedar City, Utah, United States

Logan Regional Hospital, Logan, Utah, United States

Cottonwood Hospital Medical Center, Murray, Utah, United States

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray, Utah, United States

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center, Ogden, Utah, United States

Utah Valley Regional Medical Center - Provo, Provo, Utah, United States

Dixie Regional Medical Center - East Campus, Saint George, Utah, United States

LDS Hospital, Salt Lake City, Utah, United States

Utah Cancer Specialists at UCS Cancer Center, Salt Lake City, Utah, United States

Danville Regional Medical Center, Danville, Virginia, United States

Southwest Virginia Regional Cancer Center at Wellmonth Health, Norton, Virginia, United States

St. Joseph Cancer Center, Bellingham, Washington, United States

Olympic Hematology and Oncology, Bremerton, Washington, United States

Columbia Basin Hematology, Kennewick, Washington, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Harborview Medical Center, Seattle, Washington, United States

Minor and James Medical, PLLC, Seattle, Washington, United States

Group Health Central Hospital, Seattle, Washington, United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington, United States

Polyclinic First Hill, Seattle, Washington, United States

University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States

Cancer Care Northwest - Spokane South, Spokane, Washington, United States

Southwest Washington Medical Center Cancer Center, Vancouver, Washington, United States

Wenatchee Valley Medical Center, Wenatchee, Washington, United States

Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States

Contact Details

Name: Steven H. Bernstein, MD

Affiliation: James P. Wilmot Cancer Center

Role: STUDY_CHAIR

Name: Richard I. Fisher, MD

Affiliation: James P. Wilmot Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: