ID
42072
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, the first and last weekly visits during treatment cycles (week 1 and week 4), cycle observation visits, possible unscheduled and withdrawal visits.
Link
https://clinicaltrials.gov/ct2/show/NCT00811733
Keywords
Versions (1)
- 3/16/21 3/16/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 16, 2021
DOI
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License
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Local Lab Assessments
- StudyEvent: ODM
Description
Laboratory Information
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C1533716
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2986056
Description
[read only]
Data type
text
Alias
- UMLS CUI [1]
- C0022877
Description
Select the correct laboratory number, based on the laboratories entered in the LABS form.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1524063
- UMLS CUI [1,2]
- C0022877
Description
Local Lab Assessments
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0431080
Description
Cryoglobulin
Data type
text
Alias
- UMLS CUI [1]
- C0202093
Description
Cryoglobulin measurement, positive
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0202093
- UMLS CUI [1,2]
- C1446409
Description
Cold agglutinin measurement, Titer, numerator
Data type
integer
Alias
- UMLS CUI [1,1]
- C0201281
- UMLS CUI [1,2]
- C0475208
- UMLS CUI [1,3]
- C2825219
Description
Cold agglutinin measurement, Titer, denominator
Data type
integer
Alias
- UMLS CUI [1,1]
- C0201281
- UMLS CUI [1,2]
- C0475208
- UMLS CUI [1,3]
- C2825218
Description
Serum viscosity
Data type
float
Alias
- UMLS CUI [1,1]
- C0229671
- UMLS CUI [1,2]
- C0042784
Description
Rheumatoid factor measurement, Titer, numerator
Data type
integer
Alias
- UMLS CUI [1,1]
- C0201660
- UMLS CUI [1,2]
- C0475208
- UMLS CUI [1,3]
- C2825219
Description
Rheumatoid factor measurement, Titer, denominator
Data type
integer
Alias
- UMLS CUI [1,1]
- C0201660
- UMLS CUI [1,2]
- C0475208
- UMLS CUI [1,3]
- C2825218
Similar models
Local Lab Assessments
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C1533716 (UMLS CUI-2)
C0022877 (UMLS CUI [1,2])
C0205276 (UMLS CUI-2)
C0431080 (UMLS CUI-3)
C1446409 (UMLS CUI [1,2])
C0475208 (UMLS CUI [1,2])
C2825219 (UMLS CUI [1,3])
C0475208 (UMLS CUI [1,2])
C2825218 (UMLS CUI [1,3])
C0042784 (UMLS CUI [1,2])
C0475208 (UMLS CUI [1,2])
C2825219 (UMLS CUI [1,3])
C0475208 (UMLS CUI [1,2])
C2825218 (UMLS CUI [1,3])