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NCT02658968 · OUTCOME

The Best Overall Tumour Response

Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05) · Source last updated 2024-01-16

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
3 months - 2 years

What was measured

Efficacy evaluations are measured by tumour response rates using CT and PET/CT imaging with responses classified as described in "Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification" (Cheson, 2014). The Cheson criteria, 2014 are a combined score taking into consideration, positive or negative scored PET scan, the contrast enhanced CT images and bone marrow biopsies when available.

Analysis population: Participants who had a baseline and at least one post-baseline computed tomography scan

Groups in this outcome

60/10

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing.

100/10

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.

100/15

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.

100/20

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.

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

Analysis denominator · Participants

GroupSource count
60/101
100/102
100/152
100/203

Reported measurements

Source class 1

Progressive disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
60/101Not reportedNot reportedNot reportedNot reported
100/101Not reportedNot reportedNot reportedNot reported
100/151Not reportedNot reportedNot reportedNot reported
100/201Not reportedNot reportedNot reportedNot reported

No response/stable disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
60/100Not reportedNot reportedNot reportedNot reported
100/101Not reportedNot reportedNot reportedNot reported
100/150Not reportedNot reportedNot reportedNot reported
100/201Not reportedNot reportedNot reportedNot reported

Complete response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
60/100Not reportedNot reportedNot reportedNot reported
100/100Not reportedNot reportedNot reportedNot reported
100/151Not reportedNot reportedNot reportedNot reported
100/201Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      title
      Progressive disease
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      title
      No response/stable disease
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      title
      Complete response
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      3
    units
    Participants
description
Efficacy evaluations are measured by tumour response rates using CT and PET/CT imaging with responses classified as described in "Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification" (Cheson, 2014). The Cheson criteria, 2014 are a combined score taking into consideration, positive or negative scored PET scan, the contrast enhanced CT images and bone marrow biopsies when available.
groups
  1. description
    Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing.
    id
    OG000
    title
    60/10
  2. description
    Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
    id
    OG001
    title
    100/10
  3. description
    Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
    id
    OG002
    title
    100/15
  4. description
    Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
    id
    OG003
    title
    100/20
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants who had a baseline and at least one post-baseline computed tomography scan
reporting Status
POSTED
time Frame
3 months - 2 years
title
The Best Overall Tumour Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice