ID
41896
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 CT Organ exam form has to be filled out at the screening visit, cycle 1 and 2 observation visits and possible unscheduled visits. The CT Lymphnode Screening only has to be filled out at screening.
Link
https://clinicaltrials.gov/ct2/show/NCT00811733
Keywords
Versions (2)
- 2/9/21 2/9/21 -
- 2/10/21 2/10/21 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
February 10, 2021
DOI
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License
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
CT Imaging
- StudyEvent: ODM
Description
CT Organ Exam
Alias
- UMLS CUI-1
- C0178784
- UMLS CUI-2
- C0040405
Description
Liver Size
Data type
integer
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0456389
Description
Hepatomegaly, size
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0019209
- UMLS CUI [1,2]
- C0456389
Description
Spleen Size
Data type
integer
Alias
- UMLS CUI [1,1]
- C0037993
- UMLS CUI [1,2]
- C0456389
Description
Splenomegaly, Size
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0038002
- UMLS CUI [1,2]
- C0456389
Description
Lymph node CT screening assessments
Alias
- UMLS CUI-1
- C0024204
- UMLS CUI-2
- C0040405
- UMLS CUI-3
- C1710477
Description
This and the following items of this group only have to be filled out at the screening visit.
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040405
Description
Please enter the six largest lymph nodes (>= 1.5 cm) to be evaluated through out the study.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0237753
Description
Lymph node
Data type
text
Alias
- UMLS CUI [1]
- C0024204
Description
Lymph node location
Data type
text
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0450429
Description
Lymph node, longest diameter
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C1301886
- UMLS CUI [1,2]
- C1522425
- UMLS CUI [1,3]
- C0024204
Description
Lymph node, shortest diameter
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C1301886
- UMLS CUI [1,2]
- C1806781
- UMLS CUI [1,3]
- C0024204
Similar models
CT Imaging
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0040405 (UMLS CUI-2)
C1710477 (UMLS CUI-3)
C0040405 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C1522425 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,3])
C1806781 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,3])