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Spots Global Cancer Trial Database for Fludarabine Followed by Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia

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Trial Identification

Brief Title: Fludarabine Followed by Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia

Official Title: A Phase II Study of Fludarabine Induction Followed by CAMPATH-1H Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia

Study ID: NCT00004857

Conditions

Leukemia

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of fludarabine followed by alemtuzumab in treating patients who have chronic lymphocytic leukemia.

Detailed Description: OBJECTIVES: I. Determine the overall response rate of previously untreated patients with stage I, II, III, or IV B-cell chronic lymphocytic leukemia when treated with fludarabine induction followed by alemtuzumab consolidation. II. Determine the infectious toxic effects and feasibility of this regimen in this patient population. III. Determine the treatment-related toxic effects, including infection and injection site reactions, of subcutaneous vs intravenous alemtuzumab in patients treated with this regimen. IV. Determine the progression-free and overall survival of patients treated with this regimen. V. Determine the immunologic effects of this regimen in these patients. OUTLINE: Patients receive fludarabine IV over 30 minutes 5 days a week. Treatment repeats every 28 days for 4 courses in the absence of disease progression. Patients undergo clinical staging after completion of course 4 of fludarabine followed by 2 months of observation. Patients with stable or responding disease receive alemtuzumab subcutaneously 3 days a week for 6 weeks. Patients undergo clinical staging again after completion of 6 weeks of alemtuzumab followed by 2 more months of observation. Patients are followed every 3 months for 1 year and then every 6 months for 8 years.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Veterans Affairs Medical Center - Birmingham, Birmingham, Alabama, United States

University of California San Diego Cancer Center, La Jolla, California, United States

Veterans Affairs Medical Center - San Francisco, San Francisco, California, United States

UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States

CCOP - Christiana Care Health Services, Wilmington, Delaware, United States

Lombardi Cancer Center, Washington, District of Columbia, United States

Walter Reed Army Medical Center, Washington, District of Columbia, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States

University of Illinois at Chicago Health Sciences Center, Chicago, Illinois, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States

University of Chicago Cancer Research Center, Chicago, Illinois, United States

Holden Comprehensive Cancer Center at The University of Iowa, Iowa City, Iowa, United States

Veterans Affairs Medical Center - Togus, Togus, Maine, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota, United States

Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, United States

Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States

Barnes-Jewish Hospital, Saint Louis, Missouri, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States

Norris Cotton Cancer Center, Lebanon, New Hampshire, United States

Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

CCOP - North Shore University Hospital, Manhasset, New York, United States

North Shore University Hospital, Manhasset, New York, United States

Long Island Jewish Medical Center, New Hyde Park, New York, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

New York Presbyterian Hospital - Cornell Campus, New York, New York, United States

Mount Sinai Medical Center, NY, New York, New York, United States

State University of New York - Upstate Medical University, Syracuse, New York, United States

Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States

Veterans Affairs Medical Center - Durham, Durham, North Carolina, United States

Duke Comprehensive Cancer Center, Durham, North Carolina, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States

Rhode Island Hospital, Providence, Rhode Island, United States

Medical University of South Carolina, Charleston, South Carolina, United States

University of Tennessee, Memphis Cancer Center, Memphis, Tennessee, United States

Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, United States

CCOP - Southwestern Vermont Regional Cancer Center, Bennington, Vermont, United States

Vermont Cancer Center, Burlington, Vermont, United States

Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont, United States

Veterans Affairs Medical Center - Richmond, Richmond, Virginia, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia, United States

Contact Details

Name: Kanti R. Rai, MD

Affiliation: Long Island Jewish Medical Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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