Combination Chemotherapy and Pralatrexate as First-Line Therapy in Treating Patients With Non-Hodgkin Lymphoma

Completed · Phase 2

Conditions studied: Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Hepatosplenic T-cell Lymphoma, Peripheral T-cell Lymphoma

In brief

This phase II trial studies how well combination chemotherapy and pralatrexate works in treating patients with non-Hodgkin lymphoma (NHL). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing

Key facts

Study ID: NCT01336933
Run by: University of Nebraska
People needed: 34
Starts: 2011-07-06
Expected to finish: 2016-12-28
Last updated by the study team: 2023-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed new diagnosis of Stage II, III and IV peripheral T-cell NHL not otherwise specified (NOS), anaplastic large cell lymphoma (ALK negative) (ALK positive if international prognostic index [IPI] 3, 4, or 5), angioimmunoblastic T-cell lymphoma, enteropathy associated T-cell lymphoma, hepatosplenic gamma delta T-cell lymphoma
Pathology material (hematoxylin and eosin [H\&E] stain, immunohistochemistry [IHC] and pathology report from initial diagnosis, if slides are not available, then 8 unstained slides of 4 micron thickness or a representative block should be sent) will be reviewed, and the diagnosis confirmed by University Nebraska Medical Center (UNMC) pathology department (retrospective diagnostic review: treatment may commence prior to the UNMC review)
No prior therapy with the exception of prior radiation therapy and 1 cycle of chemotherapy based on current diagnosis and clinical condition
Age 19 years or older (the age of consent in Nebraska); age 18 years or older (applicable to states where the age of majority is 18)
Expected survival duration of >= six months
Karnofsky Performance Status >= 70
Absolute neutrophil count (ANC) >= 1000 cells/mm\^3, unless due to lymphoma involvement of the bone marrow
Platelet Count >= 100 mm\^3, unless due to lymphoma involvement of the bone marrow
Total bilirubin =< 1.5 x upper normal limit (ULN), or =< 3 x ULN if documented hepatic involvement with lymphoma, or =< 5 x ULN if history of Gilbert's Disease
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (=< 5 x ULN if documented hepatic involvement with lymphoma)
Serum potassium within normal range
Serum creatinine < 2.0 mg/dL or calculated creatinine clearance (CrCl) > 45 mL/min
Prothrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time (PTT) =< 1.5 x ULN unless patient is receiving anticoagulants; if patient is on anticoagulation therapy, levels should be within therapeutic range
Patients with measurable disease; patients with non-measurable but evaluable disease may be eligible after discussion with the principal investigator (PI); baseline measurements and evaluations must be obtained within 6 weeks of registration to the study; abnormal positron emission tomography (PET) scans will not constitute evaluable disease, unless verified by computed tomography (CT) scan or other appropriate imaging
Patients with measurable disease must have at least one objective measurable disease parameter; a clearly defined, bidimensionally measurable defect or mass measuring at least 2 cm in diameter on a CT scan will constitute measurable disease; proof of lymphoma in the liver is required by a confirmation biopsy
Women must not be pregnant or breast-feeding due to teratogenic effects of chemotherapy
All females of childbearing potential must have a blood test within 2 weeks prior to registration to rule out pregnancy
Pregnancy testing is not required for post-menopausal or surgically sterilized women
Male and female patients of reproductive potential must agree follow accepted birth control measures
Patient must be able to adhere to the study visit schedule and other protocol requirements
Patients must be willing to give written informed consent, and sign an institutionally approved consent form before performance of any study-related procedure not part of normal medical care; with the exception of 1 cycle of chemotherapy based on current diagnosis and clinical condition, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
No serious disease or condition that, in the opinion of the investigator, would compromise the patient's ability to participate in the study

You may not qualify if…

Pregnant or breast feeding females
Known positive for human immunodeficiency virus (HIV), human T-lymphotropic virus type 1 (HTLV-1), or infectious hepatitis, type A, B or C or active hepatitis
Major surgery within 2 weeks of study drug administration
Prior malignancies within the past 3 years with exception of adequately treated basal cell, squamous cell skin cancer, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen (PSA) levels
Patients with a diagnosis of other peripheral T-cell lymphoma (PTCL) histologies other than those specified in the inclusion criteria
Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Concomitant administration of nonsteroidal anti-inflammatory drugs (NSAIDs) and trimethoprim/sulfamethoxazole will not be allowed, since these may result in delayed clearance of pralatrexate

Where it is running

Mayo Clinic, Arizona — Scottsdale, Arizona, United States
Stanford University — Stanford, California, United States
Emory University School Of Medicine — Atlanta, Georgia, United States
University of Chicago — Chicago, Illinois, United States
University of Massachusetts Medical School — Worcester, Massachusetts, United States
Mayo Clinic — Rochester, Minnesota, United States
Siteman Cancer Center, Washington University — St Louis, Missouri, United States
Eppley Cancer Center, University of Nebraska Medical Center — Omaha, Nebraska, United States
Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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