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NCT01075321 · OUTCOME

Best Response to Dose Level 0

Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma · Source last updated 2020-10-22

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 5 years

What was measured

Patients were assessed using the Cheson et al. Revised Response Criteria for Malignant Lymphoma (Cheson, et al 2007). A Complete Response (CR) was defined as the disappearance of all evidence of disease, no palpable nodules and bone marrow cleared on biopsy. A Partial Response (PR) was defined as regression of measureable disease and no new sites, with a 50% decrease in sum of the products of dimension (SPD) of nodal masses, and no increase in spleen or liver size. Patients with Waldenstrom's Macroglobulinemia were eligible to be evaluated as a Minor Response (MR) in which a reduction between 25% and 50% of serum monoclonal IgM was observed. A Progression (PD) was defined as having any new lesions or a 50% increase in the SPD of any previously involved nodes. A Stable Disease (SD) is the absence of any of the previously defined responses.

Analysis population: All patients that were registered and treated at Dose Level 0 were pooled and included in this endpoint. 9 patients in Phase I and 32 patients in Phase II were treated and evaluable for this endpoint

Groups in this outcome

Dose Level 0

Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Dose Level 041

Reported measurements

Source class 1

Complete Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 04Not reportedNot reportedNot reportedNot reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 08Not reportedNot reportedNot reportedNot reported

Minor Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 01Not reportedNot reportedNot reportedNot reported

Stable Disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 016Not reportedNot reportedNot reportedNot reported

Progression

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 012Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      title
      Complete Response
    2. measurements
      1. group Id
        OG000
        value
        8
      title
      Partial Response
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Minor Response
    4. measurements
      1. group Id
        OG000
        value
        16
      title
      Stable Disease
    5. measurements
      1. group Id
        OG000
        value
        12
      title
      Progression
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    units
    Participants
description
Patients were assessed using the Cheson et al. Revised Response Criteria for Malignant Lymphoma (Cheson, et al 2007). A Complete Response (CR) was defined as the disappearance of all evidence of disease, no palpable nodules and bone marrow cleared on biopsy. A Partial Response (PR) was defined as regression of measureable disease and no new sites, with a 50% decrease in sum of the products of dimension (SPD) of nodal masses, and no increase in spleen or liver size. Patients with Waldenstrom's Macroglobulinemia were eligible to be evaluated as a Minor Response (MR) in which a reduction between 25% and 50% of serum monoclonal IgM was observed. A Progression (PD) was defined as having any new lesions or a 50% increase in the SPD of any previously involved nodes. A Stable Disease (SD) is the absence of any of the previously defined responses.
groups
  1. description
    Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Dose Level 0
param Type
COUNT_OF_PARTICIPANTS
population Description
All patients that were registered and treated at Dose Level 0 were pooled and included in this endpoint. 9 patients in Phase I and 32 patients in Phase II were treated and evaluable for this endpoint
reporting Status
POSTED
time Frame
Up to 5 years
title
Best Response to Dose Level 0
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice