ID
41870
Description
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out at the Screening Visit.
Lien
https://clinicaltrials.gov/ct2/show/NCT00811733
Mots-clés
Versions (1)
- 08/02/2021 08/02/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
8 février 2021
DOI
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Licence
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Prior WM Therapy
- StudyEvent: ODM
Description
Previous WM Treatment Status
Alias
- UMLS CUI-1
- C0205156
- UMLS CUI-2
- C0749659
- UMLS CUI-3
- C0024419
Description
Prior Waldenstrom's Macroglobulinemia Therapy
Alias
- UMLS CUI-1
- C1514463
- UMLS CUI-2
- C0024419
Description
[hidden]
Type de données
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C2348184
Description
[hidden]
Type de données
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C2826819
Description
[hidden]
Type de données
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C0871468
Description
[hidden]
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C1516698
- UMLS CUI [1,5]
- C0805701
Description
[hidden]
Type de données
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C0805701
- UMLS CUI [1,4]
- C0231175
Description
Prior therapy for WM, Regimen sequence
Type de données
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C1276413
- UMLS CUI [1,4]
- C2348184
Description
Prior therapy for WM, therapy type
Type de données
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C0332307
Description
Prior therapy for WM, number of cycles/doses
Type de données
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C0449788
- UMLS CUI [1,4]
- C1302181
- UMLS CUI [2,1]
- C1514463
- UMLS CUI [2,2]
- C0024419
- UMLS CUI [2,3]
- C0449788
- UMLS CUI [2,4]
- C0178602
Description
Prior therapy for WM, Units
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C0439148
Description
Prior therapy for WM, cumulative dose
Type de données
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C2986497
Description
Prior therapy for WM, dose units
Type de données
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1519795
Description
Prior therapy for WM, intent
Type de données
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C1283828
Description
Prior therapy for WM, start date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C0808070
Description
Prior therapy for WM, end date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C0806020
Description
Prior therapy for WM, best response
Type de données
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C2986560
Description
Prior therapy for WM, duration of response
Type de données
integer
Unités de mesure
- weeks
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C0237585
Similar models
Prior WM Therapy
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0749659 (UMLS CUI-2)
C0024419 (UMLS CUI-3)
C0024419 (UMLS CUI [1,2])
C0024419 (UMLS CUI-2)
C0024419 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
C0024419 (UMLS CUI [1,2])
C2826819 (UMLS CUI [1,3])
C0024419 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0871468 (UMLS CUI [1,4])
C0871468 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1516698 (UMLS CUI [1,4])
C0805701 (UMLS CUI [1,5])
C0024419 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0024419 (UMLS CUI [1,2])
C1276413 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
C0024419 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0024419 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C1302181 (UMLS CUI [1,4])
C1514463 (UMLS CUI [2,1])
C0024419 (UMLS CUI [2,2])
C0449788 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])
C0024419 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
C0024419 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])
C0024419 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
C0024419 (UMLS CUI [1,2])
C1283828 (UMLS CUI [1,3])
C0024419 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0024419 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0024419 (UMLS CUI [1,2])
C2986560 (UMLS CUI [1,3])
C0024419 (UMLS CUI [1,2])
C0237585 (UMLS CUI [1,3])