ID
44787
Beschrijving
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. Depending on which items, this form has to be filled out at the Cycle 1 week 1, 2, 3 and 4 visits, Cycle 2 week 1, 2, 3 and 4 visits, Cycle 1 and 2 observation visits and unscheduled visits.
Link
https://clinicaltrials.gov/ct2/show/NCT00811733
Trefwoorden
Versies (1)
- 26-11-21 26-11-21 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
26 november 2021
DOI
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Licentie
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
PK Blood Sample
- StudyEvent: ODM
Beschrijving
Dosing date and time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Beschrijving
PK Blood Sample (Pre and Post Dose)
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005834
Beschrijving
For both cycles collect a sample for all timepoints herein in week 1 and 4, pre-infusion only in week 2 and 3. For the cycles' observation samples and "any time" samples this item is not needed.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0031328
- UMLS CUI [1,5]
- C0005834
Beschrijving
pharmacokinetics sample taken
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschrijving
Pre infusion, sample taken, start date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1264639
Beschrijving
Pre infusion, sample taken, sample identifier
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1299222
Similar models
PK Blood Sample
- StudyEvent: ODM
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C1264639 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
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C0005834 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0031328 (UMLS CUI [1,4])
C0005834 (UMLS CUI [1,5])
C0031328 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0031328 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])