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NCT01336933 · OUTCOME

Complete Response Rate of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) and Pralatrexate (P) Treatment

Combination Chemotherapy and Pralatrexate as First-Line Therapy in Treating Patients With Non-Hodgkin Lymphoma · Source last updated 2023-09-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants analyzed
Interval / dispersion
Not reported
Time frame
168 days - 252 days (4-6 courses; 42 days per course)

What was measured

Complete Response Rate (CR) was reported at the end of the CEOP-P (6 courses for patients not receiving transplant and 4-6 courses for patients receiving transplant). Response assessment was performed by computerized tomography (CT) or positron emission tomography (PET)/CT based on the investigator's preference after cycles 2, 4 and 6. Response was assessed by the treating physician according to the Cheson Revised response criteria (Cheson et al,, 2007) or International Harmonization Project criteria (Cheson, 2007), based on imaging modality used. Complete Response Definition: Disappearance of all evidence of disease Nodal Masses: (a) \[18F\]fluorodeoxyglucose(FDG)-avid or PET positive prior to therapy; mass of any size permitted if PETnegative (b) Variably FDG-avid or PET negative; regression to normal size on CT Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative

Groups in this outcome

Treatment (Chemotherapy and Enzyme Inhibitor Therapy)

Patients receive cyclophosphamide IV and vincristine sulfate IV on day 1, etoposide IV on days 1-3 or PO 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. prednisone: Given PO cyclophosphamide: Given IV etoposide: Given PO or IV vincristine sulfate: Given IV pralatrexate: Given IV laboratory biomarker analysis: Correlative studies comparative genomic hybridization: Correlative studies gene expression analysis: Correlative studies nucleic acid sequencing: Correlative studies mutation analysis: Correlative studies

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)33

Reported measurements

Source class 1
Values in percentage of participants analyzed · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)52Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        52
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Complete Response Rate (CR) was reported at the end of the CEOP-P (6 courses for patients not receiving transplant and 4-6 courses for patients receiving transplant). Response assessment was performed by computerized tomography (CT) or positron emission tomography (PET)/CT based on the investigator's preference after cycles 2, 4 and 6. Response was assessed by the treating physician according to the Cheson Revised response criteria (Cheson et al,, 2007) or International Harmonization Project criteria (Cheson, 2007), based on imaging modality used. Complete Response Definition: Disappearance of all evidence of disease Nodal Masses: (a) \[18F\]fluorodeoxyglucose(FDG)-avid or PET positive prior to therapy; mass of any size permitted if PETnegative (b) Variably FDG-avid or PET negative; regression to normal size on CT Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative
groups
  1. description
    Patients receive cyclophosphamide IV and vincristine sulfate IV on day 1, etoposide IV on days 1-3 or PO 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. prednisone: Given PO cyclophosphamide: Given IV etoposide: Given PO or IV vincristine sulfate: Given IV pralatrexate: Given IV laboratory biomarker analysis: Correlative studies comparative genomic hybridization: Correlative studies gene expression analysis: Correlative studies nucleic acid sequencing: Correlative studies mutation analysis: Correlative studies
    id
    OG000
    title
    Treatment (Chemotherapy and Enzyme Inhibitor Therapy)
param Type
NUMBER
reporting Status
POSTED
time Frame
168 days - 252 days (4-6 courses; 42 days per course)
title
Complete Response Rate of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) and Pralatrexate (P) Treatment
type
PRIMARY
unit Of Measure
percentage of participants analyzed

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice