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NCT01336933 · OUTCOME

Overall Response Rates (ORR)= (Complete Response Rates (CR) + Partial Response Rates (PR))

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
2 years

What was measured

Every patient who fulfills all aspects of patient eligibility who receives at least 2 complete courses of chemotherapy will be evaluable for the response endpoint. Response rates will be descriptively summarized using percentages and 95% confidence intervals. Complete Response Definition: Defined in Primary Objective Partial Response Definition: Regression of measurable disease and no new sites, Nodal Masses: \> 50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes 1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site 2. Variably FDG-avid or PET negative; regression on CT Spleen, Liver:\> 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified

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)70Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        70
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Every patient who fulfills all aspects of patient eligibility who receives at least 2 complete courses of chemotherapy will be evaluable for the response endpoint. Response rates will be descriptively summarized using percentages and 95% confidence intervals. Complete Response Definition: Defined in Primary Objective Partial Response Definition: Regression of measurable disease and no new sites, Nodal Masses: \> 50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes 1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site 2. Variably FDG-avid or PET negative; regression on CT Spleen, Liver:\> 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified
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
2 years
title
Overall Response Rates (ORR)= (Complete Response Rates (CR) + Partial Response Rates (PR))
type
SECONDARY
unit Of Measure
percentage of participants analyzed

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

Preserved source evidence · Not medical advice