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NCT00255801 · OUTCOME

Maximum Therapeutic Response

Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma · Source last updated 2018-08-16

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
2 years

What was measured

CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT * CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment. * CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome. * Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) \[12, 13\]; the Composite Assessment of Index Lesion Severity (CA) \[9, 14\] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease

Groups in this outcome

Doxil and Targretin® (Bexarotene)

Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse.

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

Analysis denominator · Participants

GroupSource count
Doxil and Targretin® (Bexarotene)37

Reported measurements

Source class 1

Clinical Complete Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Doxil and Targretin® (Bexarotene)2Not reportedNot reportedNot reportedNot reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Doxil and Targretin® (Bexarotene)12Not reportedNot reportedNot reportedNot reported

Stable Disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Doxil and Targretin® (Bexarotene)6Not reportedNot reportedNot reportedNot reported

Progressive Disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Doxil and Targretin® (Bexarotene)14Not reportedNot reportedNot reportedNot reported

Not Evaluable

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Doxil and Targretin® (Bexarotene)3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      title
      Clinical Complete Response
    2. measurements
      1. group Id
        OG000
        value
        12
      title
      Partial Response
    3. measurements
      1. group Id
        OG000
        value
        6
      title
      Stable Disease
    4. measurements
      1. group Id
        OG000
        value
        14
      title
      Progressive Disease
    5. measurements
      1. group Id
        OG000
        value
        3
      title
      Not Evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
description
CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT * CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment. * CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome. * Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) \[12, 13\]; the Composite Assessment of Index Lesion Severity (CA) \[9, 14\] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease
groups
  1. description
    Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse.
    id
    OG000
    title
    Doxil and Targretin® (Bexarotene)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
2 years
title
Maximum Therapeutic Response
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice