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
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, expression of nucleoside transporters, and expression
of other pertinent genes by tissue microarray) and cytogenetic factors on prognosis in
this patient population.
- To investigate, preliminarily, whether the expression of specific genes, such as OPAL-1
(outcome predictor in acute leukemia 1), RANTES, and connective tissue growth factor,
associated with poor outcome in retrospective studies, correlates with outcome in this
study.(Closed as of 07/01/2010)
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.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then annually for 3 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete remission (CR) rate (CR and incomplete CR)
5 years
No
Anjali Advani, MD
Study Chair
The Cleveland Clinic
United States: Federal Government
CDR0000649725
NCT00945815
September 2010
July 2017
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Greenville | Greenville, South Carolina 29615 |
LDS Hospital | Salt Lake City, Utah 84143 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Houston | Houston, Texas 77030 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
University of California Davis Cancer Center | Sacramento, California 95817 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
American Fork Hospital | American Fork, Utah 84003 |
Logan Regional Hospital | Logan, Utah 84321 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Polyclinic First Hill | Seattle, Washington 98122 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
Stanford Cancer Center | Stanford, California 94305-5824 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Wayne Hospital | Greenville, Ohio 45331 |
Sandra L. Maxwell Cancer Center | Cedar City, Utah 84720 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Columbia Basin Hematology | Kennewick, Washington 99336 |
Harrison Poulsbo Hematology and Onocology | Poulsbo, Washington 98370 |
Evergreen Hematology and Oncology, PS | Spokane, Washington 99218 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
Ben Taub General Hospital | Houston, Texas 77030 |
Cancer Centers of the Carolinas - Grove Commons | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Greer Medical Oncology | Greer, South Carolina 29650 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Hematology-Oncology Clinic | Baton Rouge, Louisiana 70808 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital | Houston, Texas 77030 |
Island Hospital Cancer Care Center at Island Hospital | Anacortes, Washington 98221 |
Highline Medical Center Cancer Center | Burien, Washington 98166 |
Swedish Medical Center - Issaquah Campus | Issaquah, Washington 98029 |