Spots Global Cancer Trial Database for Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
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Trial Identification
Brief Title: Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Official Title: A Multi-Center, Phase 2, Open-Label Study of (RS)-10-Propargyl-10-Deazaaminopterin (Pralatrexate) With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Study ID: NCT00364923
Conditions
Interventions
Study Description
Brief Summary: Primary • Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) Secondary * Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory PTCL * Determine the pharmacokinetic (PK) profile of pralatrexate when administered with vitamin B12 and folic acid supplementation
Detailed Description: This is a Phase 2, single arm, non-randomized, open-label, multi-center study designed to evaluate the safety and effectiveness of pralatrexate when administered with vitamin B12 and folic acid supplementation to patients with relapsed or refractory PTCL. Pralatrexate will be given over 3-5 minutes intravenously (IV), which means through a vein. If pralatrexate is tolerated well, the patient will receive IV injections of pralatrexate every week for 6 weeks, followed by 1 week without receiving pralatrexate. These 7 week cycles will be repeated depending on response and tolerability.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
University of California at Los Angeles, Los Angeles, California, United States
Yale University School of Medicine, New Haven, Connecticut, United States
Emory University, Atlanta, Georgia, United States
University of Chicago Hospital, Chicago, Illinois, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Tulane Cancer Center, New Orleans, Louisiana, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Nevada Cancer Institute, Las Vegas, Nevada, United States
The Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
New York Presbyterian Hospital, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
University of Rochester Cancer Center, Rochester, New York, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
UT MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Cliniques Universitaire Saint-Luc, Brussels, , Belgium
Cliniques Universitaires UCL, Yvoir, , Belgium
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
CHU Henri Mondor, Creteil, , France
CHU DIJON - Hôpital d'enfant, Dijon, , France
CHU Nice - Hôpital de l'Archet 1, Nice, , France
CHU Nantes - Hôtel Dieu, Paris, , France
CHU Saint Louis, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Benite, , France
CHU Robert Debré, Reims, , France
Ospedale Sant'Orsola - Policlinico Sant'Orsola, Bologna, , Italy
St. Georges Hospital, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Contact Details
Name: Owen O'Connor, MD, PhD
Affiliation: Columbia University
Role: STUDY_CHAIR
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