S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
- Conditions
- Leukemia
- Interventions
- Registration Number
- NCT00945815
- Lead Sponsor
- SWOG Cancer Research Network
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description treatment epratuzumab AraC 1 g/m2/d IV Days 1-5 clofarabine 40 mg/m2/d IV Days 2-6 epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28 acetaminophen 650 mg/d PO Days 7, 14, 21, 28 diphenhydramine 50 mg/d IV Days 7, 14, 21, 28 IT methotrexate 12 mg IT at least 1 wk apart during induction All give 1 cycle treatment clofarabine AraC 1 g/m2/d IV Days 1-5 clofarabine 40 mg/m2/d IV Days 2-6 epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28 acetaminophen 650 mg/d PO Days 7, 14, 21, 28 diphenhydramine 50 mg/d IV Days 7, 14, 21, 28 IT methotrexate 12 mg IT at least 1 wk apart during induction All give 1 cycle treatment cytarabine AraC 1 g/m2/d IV Days 1-5 clofarabine 40 mg/m2/d IV Days 2-6 epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28 acetaminophen 650 mg/d PO Days 7, 14, 21, 28 diphenhydramine 50 mg/d IV Days 7, 14, 21, 28 IT methotrexate 12 mg IT at least 1 wk apart during induction All give 1 cycle treatment laboratory biomarker analysis AraC 1 g/m2/d IV Days 1-5 clofarabine 40 mg/m2/d IV Days 2-6 epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28 acetaminophen 650 mg/d PO Days 7, 14, 21, 28 diphenhydramine 50 mg/d IV Days 7, 14, 21, 28 IT methotrexate 12 mg IT at least 1 wk apart during induction All give 1 cycle
- Primary Outcome Measures
Name Time Method Complete Remission After induction therapy was completed (1 or 2 months) Complete remission (CR) is defined as: \<5% marrow aspirate blasts. Blasts can be \>=5% if the blasts are found to be myeloid and there is no evidence of lymphoblasts by flow cytometry or immunostaining. Neutrophils \>= 1000/mcl; platelets \>100,000/mcl; and no blasts in the peripheral blood. C1 Extramedullary disease status as defined in the protocol. Complete remission with incomplete platelet recovery (CRi) is same as CR but platelet count may be \<=100,000/mcl and/or ANC may be \<1,000/mcl.
- Secondary Outcome Measures
Name Time Method Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events Up to 5 years Only adverse events that are possibly, probably or definitely related to study drug are reported. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Trial Locations
- Locations (81)
Wayne Hospital
🇺🇸Greenville, Ohio, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
University of Mississippi Cancer Clinic
🇺🇸Jackson, Mississippi, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Hematology-Oncology Clinic
🇺🇸Baton Rouge, Louisiana, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Cancer Centers of the Carolinas - Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Baylor University Medical Center - Houston
🇺🇸Houston, Texas, United States
Ben Taub General Hospital
🇺🇸Houston, Texas, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, 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
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Sandra L. Maxwell Cancer Center
🇺🇸Cedar City, Utah, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸Aurora, Colorado, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
🇺🇸Tampa, Florida, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
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
Stanford Cancer Center
🇺🇸Stanford, California, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, 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
Saint Louis University Cancer Center
🇺🇸Saint Louis, Missouri, United States
Tulane Cancer Center Office of Clinical Research
🇺🇸Alexandria, Louisiana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
St. Peter's Hospital
🇺🇸Helena, 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
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, 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
Cancer Centers of the Carolinas - Greer Medical Oncology
🇺🇸Greer, South Carolina, United States
Cancer Centers of the Carolinas - Seneca
🇺🇸Seneca, South Carolina, United States
Veterans Affairs Medical Center - Houston
🇺🇸Houston, Texas, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
🇺🇸Murray, Utah, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, 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
Swedish Medical Center - Issaquah Campus
🇺🇸Issaquah, Washington, United States
Highline Medical Center Cancer Center
🇺🇸Burien, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Harrison Poulsbo Hematology and Onocology
🇺🇸Poulsbo, Washington, United States
North Puget Oncology at United General Hospital
🇺🇸Sedro-Woolley, Washington, United States
Evergreen Hematology and Oncology, PS
🇺🇸Spokane, Washington, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Island Hospital Cancer Care Center at Island Hospital
🇺🇸Anacortes, Washington, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸Mount Vernon, Washington, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States