Spots Global Cancer Trial Database for S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
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Trial Identification
Brief Title: S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Official Title: S0910, A Phase II Study of Epratuzumab (NSC-716711) in Combination With Cytarabine and Clofarabine for Patients With Relapsed or Refractory Ph- Negative Precursor B-Cell Acute Lymphoblastic Leukemia
Study ID: NCT00945815
Conditions
Study Description
Brief Summary: RATIONALE: Monoclonal antibodies, such as epratuzumab, 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, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving epratuzumab together with cytarabine and clofarabine may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving epratuzumab together with cytarabine and clofarabine works in treating patients with relapsed or refractory acute lymphoblastic leukemia.
Detailed Description: OBJECTIVES: * To test whether the complete remission (CR) rate (CR and incomplete CR) in adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia is sufficiently high after treatment with cytarabine, clofarabine, and epratuzumab to warrant further investigation. * To estimate the frequency and severity of toxicities associated with the dosing schedule of cytarabine, clofarabine, and epratuzumab used in this study. * To investigate, preliminarily, the effect of laboratory correlates (minimal post-treatment residual disease) and cytogenetic factors on prognosis in this patient population. (Not reported here due to limited MRD data) OUTLINE: This is a multicenter study. Patients receive cytarabine IV over 2 hours on days 1-5, clofarabine IV over 1 hour on days 2-6, and epratuzumab IV over at least 1 hour on days 7, 14, 21, and 28 in the absence of disease progression or unacceptable toxicity\*. NOTE: \* Prophylactic intrathecal methotrexate is required for patients \< 22 years of age, and is recommended (but not required) for patients ≥ 22 years of age. Blood samples, bone marrow samples, and/or tumor tissue samples may be collected for further laboratory analysis. Patients are followed up every 3 months for 2 years, then annually for 3 years (until 5 years after registration).
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
Stanford Cancer Center, Stanford, California, United States
University of Colorado Cancer Center at UC Health Sciences Center, Aurora, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center, Grand Junction, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, 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
Tulane Cancer Center Office of Clinical Research, Alexandria, Louisiana, United States
Hematology-Oncology Clinic, Baton Rouge, Louisiana, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
University of Mississippi Cancer Clinic, Jackson, Mississippi, United States
Saint Louis University Cancer Center, Saint Louis, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
Great Falls Clinic - Main Facility, Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Glacier Oncology, PLLC, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, 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
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, 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
CCOP - Dayton, Dayton, Ohio, United States
Blanchard Valley Medical Associates, Findlay, Ohio, United States
Middletown Regional Hospital, Franklin, Ohio, United States
Wayne Hospital, Greenville, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
Cancer Centers of the Carolinas - Faris Road, Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Grove Commons, Greenville, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Greer Medical Oncology, Greer, South Carolina, United States
Cancer Centers of the Carolinas - Seneca, Seneca, South Carolina, United States
Cancer Centers of the Carolinas - Spartanburg, Spartanburg, South Carolina, United States
Baylor University Medical Center - Houston, Houston, Texas, United States
Ben Taub General Hospital, Houston, Texas, United States
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital, Houston, Texas, United States
Veterans Affairs Medical Center - Houston, Houston, 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
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
Island Hospital Cancer Care Center at Island Hospital, Anacortes, Washington, United States
St. Joseph Cancer Center, Bellingham, Washington, United States
Olympic Hematology and Oncology, Bremerton, Washington, United States
Highline Medical Center Cancer Center, Burien, Washington, United States
Swedish Medical Center - Issaquah Campus, Issaquah, Washington, United States
Columbia Basin Hematology, Kennewick, Washington, United States
Skagit Valley Hospital Cancer Care Center, Mount Vernon, Washington, United States
Harrison Poulsbo Hematology and Onocology, Poulsbo, Washington, United States
Harborview Medical Center, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, 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
North Puget Oncology at United General Hospital, Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Evergreen Hematology and Oncology, PS, Spokane, 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: Anjali Advani, MD
Affiliation: The Cleveland Clinic
Role: STUDY_CHAIR
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