ID
42514
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. The different parts of this form have to be filled out at the Screening Visit and/or at unscheduled visits.
Link
https://clinicaltrials.gov/ct2/show/NCT00811733
Keywords
Versions (1)
- 8/11/21 8/11/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 11, 2021
DOI
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License
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Histology
- StudyEvent: ODM
Description
Waldenstrom's Histology
Alias
- UMLS CUI-1
- C0024419
- UMLS CUI-2
- C0019638
Description
Waldenstrom Histology, Date sample taken
Data type
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0024419
- UMLS CUI [1,3]
- C0019638
Description
Positive - Unequivocal histologic evidence of WM Negative - No Histologic evidence of WM Indeterminate - Bone marrow demonstrates lymphoplastic cells whose identity cannot be determined
Data type
text
Alias
- UMLS CUI [1,1]
- C0024419
- UMLS CUI [1,2]
- C0019638
Description
[hidden]
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0024419
- UMLS CUI [1,2]
- C0750484
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0334633
- UMLS CUI [1,2]
- C3887511
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0678257
Description
Lymphoplasmacytic lymphoma histology
Alias
- UMLS CUI-1
- C0334633
- UMLS CUI-2
- C0019638
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]
- C0022877
- UMLS CUI [1,2]
- C1524063
Description
Please enter % of overall cellularity (estimated range to 10%)
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0024264
- UMLS CUI [1,3]
- C1282910
- UMLS CUI [1,4]
- C0439165
Description
Please enter % of overall cellularity (estimated range to 10%)
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0024264
- UMLS CUI [1,3]
- C0205251
- UMLS CUI [1,4]
- C0439165
Description
Please enter % of overall cellularity (estimated range to 10%)
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0032112
- UMLS CUI [1,3]
- C1282910
- UMLS CUI [1,4]
- C0439165
Description
Please enter % of overall cellularity (estimated range to 10%)
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0032112
- UMLS CUI [1,3]
- C0205251
- UMLS CUI [1,4]
- C0439165
Description
Please enter % of overall cellularity (estimated range to 10%)
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0021044
- UMLS CUI [1,2]
- C0753253
- UMLS CUI [1,3]
- C0487602
- UMLS CUI [1,4]
- C1282910
- UMLS CUI [1,5]
- C0439165
Description
Please enter % of overall cellularity (estimated range to 10%)
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0021044
- UMLS CUI [1,2]
- C0753253
- UMLS CUI [1,3]
- C0487602
- UMLS CUI [1,4]
- C0205251
- UMLS CUI [1,5]
- C0439165
Description
Please enter % of overall cellularity (estimated range to 10%)
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0021044
- UMLS CUI [1,2]
- C0285488
- UMLS CUI [1,3]
- C0487602
- UMLS CUI [1,4]
- C1282910
- UMLS CUI [1,5]
- C0439165
Description
Please enter % of overall cellularity (estimated range to 10%)
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0021044
- UMLS CUI [1,2]
- C0285488
- UMLS CUI [1,3]
- C0487602
- UMLS CUI [1,4]
- C0205251
- UMLS CUI [1,5]
- C0439165
Description
Please enter % of overall cellularity (estimated range to 10%)
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0021044
- UMLS CUI [1,2]
- C0108793
- UMLS CUI [1,3]
- C0487602
- UMLS CUI [1,4]
- C1282910
- UMLS CUI [1,5]
- C0439165
Description
Please enter % of overall cellularity (estimated range to 10%)
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0021044
- UMLS CUI [1,2]
- C0108793
- UMLS CUI [1,3]
- C0487602
- UMLS CUI [1,4]
- C0205251
- UMLS CUI [1,5]
- C0439165
Description
Please enter % of overall cellularity (estimated range to 10%)
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0021044
- UMLS CUI [1,2]
- C0054966
- UMLS CUI [1,3]
- C0487602
- UMLS CUI [1,4]
- C1282910
- UMLS CUI [1,5]
- C0439165
Description
Please enter % of overall cellularity (estimated range to 10%)
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0021044
- UMLS CUI [1,2]
- C0054966
- UMLS CUI [1,3]
- C0487602
- UMLS CUI [1,4]
- C0205251
- UMLS CUI [1,5]
- C0439165
Description
Lymphoid aggregates present
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0229653
- UMLS CUI [1,2]
- C0150312
Similar models
Histology
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0019638 (UMLS CUI-2)
C0024419 (UMLS CUI [1,2])
C0019638 (UMLS CUI [1,3])
C0019638 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,2])
C3887511 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0019638 (UMLS CUI-2)
C1524063 (UMLS CUI [1,2])
C0024264 (UMLS CUI [1,2])
C1282910 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
C0024264 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
C0032112 (UMLS CUI [1,2])
C1282910 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
C0032112 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
C0753253 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C1282910 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
C0753253 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
C0285488 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C1282910 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
C0285488 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
C0108793 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C1282910 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
C0108793 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
C0054966 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C1282910 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
C0054966 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
C0150312 (UMLS CUI [1,2])