A Phase II Study of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) Alternating With Pralatrexate (P) as Front Line Therapy for Patients With Stage II, III and IV Peripheral T-Cell Non-Hodgkin Lymphoma
I. To evaluate in a Phase II study a preliminary estimate of the complete response (CR) rate
of a new chemotherapy regimen involving Cyclophosphamide, Etoposide, Vincristine and
Prednisone (CEOP) alternating with Pralatrexate (P) as front line therapy for patients with
Stage II, III and IV Peripheral T-Cell NHL not otherwise specified (NOS), Anaplastic large
cell lymphoma (ALK negative), Angioimmunoblastic T-cell lymphoma, Enteropathy associated
T-cell lymphoma, Hepatosplenic gamma delta T-cell lymphoma followed by an optional stem cell
transplant with high dose chemotherapy and Autologous stem cell transplant.
I. To evaluate partial response (PR). II. To evaluate overall response (CR+PR). III. To
evaluate the safety and tolerability of the regimen. IV. To assess the 2 year event free
survival (EFS) and overall survival (OS) using this regimen.
V. To assess the percentage of patients who intended to receive transplant versus those who
actually proceeded with transplant.
VI. To evaluate the ability to collect peripheral blood stem cells after this regimen.
Patients receive cyclophosphamide intravenously (IV) and vincristine sulfate IV on day 1,
etoposide IV on days 1-3 or orally (PO) once daily (QD) on days 2-3, and prednisone PO QD on
days 1-5 (CEOP administration). Patients also receive pralatrexate IV over 3-5 minutes on
days 15, 22, and 29 (P administration). Treatment repeats every 42 days for up to 6 courses
in the absence of disease progression or unacceptable toxicity.
Patients with CR or PR, per investigators discretion, may then undergo hematopoietic stem
cell collection and administration of standard preparative regimen followed by hematopoietic
stem cell transplantation.
After completion of study treatment, patients are followed up for 2 years (transplant
patients) or periodically.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
CR rate of CEOP and P treatment
Every patient who fulfills all aspects of patient eligibility who receives at least 2 complete course of chemotherapy will be evaluable for the response endpoint. Response rates will be descriptively summarized using percentages and 95% confidence intervals. A CR rate > 50% would be promising if the toxicity profile is acceptable.
Up to 6 courses
University of Nebraska
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|
|Stanford University||Stanford, California 94305|
|Emory University School of Medicine||Atlanta, Georgia 30322|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|
|Mayo Clinic in Arizona||Scottsdale, Arizona 85259-5404|
|Duke University Medical Center||Durham, North Carolina 27710|
|University of Massachusetts Medical School||Worcester, Massachusetts 01605|
|University of Chicago||Chicago, Illinois 60637|
|Siteman Cancer Center at Washington University||Saint Louis, Missouri 63110|