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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate Per Independent Central Review
Patient response to treatment was determined by independent central review using International Workshop Criteria (IWC). Results present the best overall response. The initial response assessment was scheduled at week 7 (prior to Cycle 2) and then prior to every even-numbered cycle (every 14 weeks) for up to two years after first dose.
Response was assessed at 7 weeks (prior to Cycle 2) and then prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose
Owen O'Connor, MD, PhD
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|University of Rochester Cancer Center||Rochester, New York 14642|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|City of Hope National Medical Center||Los Angeles, California 91010|
|Tulane Cancer Center||New Orleans, Louisiana 70112|
|Emory University||Atlanta, Georgia 30322|
|UT MD Anderson Cancer Center||Houston, Texas 77030|
|New York Presbyterian Hospital||New York, New York 10021|
|Yale University School Of Medicine||New Haven, Connecticut 06520|
|Nevada Cancer Institute||Las Vegas, Nevada 89135|
|Columbia University Medical Center||New York, New York 10032|
|The Cancer Center at Hackensack University Medical Center||Hackensack, New Jersey 07601|
|University of California at Los Angeles||Los Angeles, California 90095|
|University of Chicago Hospital||Chicago, Illinois 60637-1470|