Clinical Trials Directory

Trials / Completed

CompletedNCT01336933

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
34 (actual)
Sponsor
University of Nebraska · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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 proceeded with transplant. VI. To evaluate the ability to collect peripheral blood stem cells after this regimen. OUTLINE: Patients receive cyclophosphamide intravenously (IV) and vincristine 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 Complete Response (CR) or Partial Response (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.

Conditions

Interventions

TypeNameDescription
DRUGprednisoneGiven PO
DRUGcyclophosphamideGiven IV
DRUGetoposideGiven PO or IV
DRUGVincristineGiven IV
DRUGpralatrexateGiven IV
OTHERlaboratory biomarker analysisCorrelative studies
GENETICcomparative genomic hybridizationCorrelative studies
GENETICgene expression analysisCorrelative studies
GENETICnucleic acid sequencingCorrelative studies
GENETICmutation analysisCorrelative studies
OTHERimmunohistochemistry staining methodCorrelative studies
GENETICmicroarray analysisCorrelative studies
GENETICRNA analysisCorrelative studies

Timeline

Start date
2011-07-06
Primary completion
2016-12-28
Completion
2016-12-28
First posted
2011-04-18
Last updated
2023-09-22
Results posted
2018-06-25

Locations

9 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01336933. Inclusion in this directory is not an endorsement.