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NCT01193842 · OUTCOME

Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II)

Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas · Source last updated 2023-11-21

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 6 months

What was measured

Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study. In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH).

Analysis population: Reviewed responses from participants who completed at least one cycle of treatment. In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH). In phase I, patients in DA-R-EPOCH were not included in the analysis.

Groups in this outcome

Phase II: VR-DA-EPOCH

Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)

Phase II: DA-R-EPOCH

Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat

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

Analysis denominator · Participants

GroupSource count
Phase II: VR-DA-EPOCH40
Phase II: DA-R-EPOCH42

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II: VR-DA-EPOCH67.5Not reported50.981.4Not reported
Phase II: DA-R-EPOCH76.2Not reported60.688.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        50.9
        upper Limit
        81.4
        value
        67.5
      2. group Id
        OG001
        lower Limit
        60.6
        upper Limit
        88.0
        value
        76.2
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      42
    units
    Participants
description
Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study. In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH).
dispersion Type
95% Confidence Interval
groups
  1. description
    Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
    id
    OG000
    title
    Phase II: VR-DA-EPOCH
  2. description
    Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
    id
    OG001
    title
    Phase II: DA-R-EPOCH
param Type
NUMBER
population Description
Reviewed responses from participants who completed at least one cycle of treatment. In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH). In phase I, patients in DA-R-EPOCH were not included in the analysis.
reporting Status
POSTED
time Frame
Up to 6 months
title
Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice