The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of relapsed or refractory B-cell Non-Hodgkin's lymphoma (NHL). The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this participant population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this participant population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Pralatrexate injection administered as intravenous (IV) push
1 mg intramuscular (IM) injection
Oral 1 mg tablet
Tower Cancer Research Foundation
Beverly Hills, California, United States
Kootenai Cancer Center
Post Falls, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Owsley Brown Frazier Cancer Center
Louisville, Kentucky, United States
Overton Brooks VA Medical Center
Shreveport, Louisiana, United States
Frontier Cancer Center and Blood Institute
Billings, Montana, United States
New York University Hospital
New York, New York, United States
Providence Cancer Center
Portland, Oregon, United States
The West Clinic (ACORN)
Memphis, Tennessee, United States
Gundersen Lutheran
La Crosse, Wisconsin, United States
...and 1 more locations
Objective Response Rate (ORR)
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR). Tumor response was evaluated on the basis of clinical and radiological criteria, assessed according to International Workshop Criteria (IWC) with or without positron emission tomography (PET) scans. Per IWC criteria CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to non-Hodgkin's lymphoma (NHL) and PR is defined as \>= 50% decrease in sum of the product of the perpendicular diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in size of other nodes, liver or spleen.
Time frame: Up to 24 months
Duration of Response (DOR)
The Duration of Response was defined as the time (in months) from the date the measurement criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that relapse or progression was documented. It was assessed according to IWC with or without PET, subject to its availability. Per IWC, progression was defined as a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.
Time frame: Up to 24 months
Progression Free Survival (PFS)
Progression-free survival (PFS) was the duration of time (in months) from first administration of study treatment to date of first documented progression or death from any cause. It was based on tumor assessments made according to the IWC with or without PET scans, subject to their availability. Per IWC, progression was defined as a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.
Time frame: Up to 24 months
Overall Survival (OS)
Overall Survival was the time (in months) from first administration of study treatment until the date of death.
Time frame: Up to 24 months
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