ID

41944

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. Both of these forms have to be filled out at the cycle observation visits. The Response Evaluation form also has to be filled out at possible unscheduled visits.

Link

https://clinicaltrials.gov/ct2/show/NCT00811733

Keywords

Versions (1)
  1. 2/19/21 2/19/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 19, 2021

DOI

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License

Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

English

Response Evaluation and Confirmation

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit/assessment
Description

date of visit/assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
subject number
Description

subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
visit type
Description

visit type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Response Evaluation
Description

Response Evaluation

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C0220825
Were there any new lymph nodes (>=1.5 cm) since the last assessment?
Description

If yes, record details on the New Lymph Node form.

Data type

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0442800
UMLS CUI [1,3]
C0205314
Please select the appropriate response.
Description

Complete Response(CR) Complete response requires all of the following criteria: - Complete disappearance of serum monoclonal IgM by immunofixation - Resolution of adenopathy and / or organomegaly - No signs or symptoms that are directly attributable to WM (unexplained recurrent fever >38.4°C, drenching night sweats, >10% body weight loss, hyperviscosity, or symptomatic cryoglobulinemia) - Absence of malignant cell by bone marrow histologic examination Reconfirmation of the CR status is required > 6 weeks later with a second immunofixation Partial Response(PR) Partial response (PR) requires all of the following criteria: - A >50% reduction in the serum monoclonal IgM concentration on protein electrophoresis - A >50% improvement in bulky lymphadenopathy and / or organomegaly on CT scan - No new signs, symptoms, or evidence of disease Minor Response(MR) Minor Response requires all of the following criteria: - At least 25% but less than 50% reduction of serum monoclonal IgM by protein electrophoresis. - No new symptoms or signs of active disease. Stable Disease(SD) - A <25% decrease or a <25% increase in the serum monoclonal IgM - No progression of adenopathy and / or organomegaly, cytopenias or clinically significant symptoms caused by WM Progressive Disease(PD) - A >25% increase in serum monoclonal IgM levels from the lowest attained response value OR - Progression of clinically significant disease related symptoms Not Evaluable - Insufficient data and / or time from treatment for a determination of response to be made. Patients must have been followed for at least 3 months after treatment initiation to be considered unresponsive to therapy. Relapse for a Complete Responder Relapse for a Complete Responder is characterized at least one of the following: - Reappearance of the serum monoclonal IgM protein as determined by immunofixation OR - Progression of clinically significant signs or symptoms attributable to WM OR - Development of any clinically significant disease related symptoms OR - Recurrence of bone marrow involvement by lymphoplasmacytic cells Progression for both a Partial Responder and a Minor Responder Progression for a Partial Responder and a Minor Responder is characterized at least one of the following: - >=25% increase in serum monoclonal IgM from the lowest attained response value determined by immunofixation. An absolute increase of 50 mg/dL (confirmed on a second determination) is required in order to define disease progression when the only criterion for progressive disease is the increase of M-protein size. OR - Progression of clinically significant signs or symptoms attributable to WM OR - Development of any new clinically significant disease related symptoms

Data type

integer

Alias
UMLS CUI [1]
C0521982
Complete Response Confirmation
Description

Complete Response Confirmation

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C0205197
UMLS CUI-3
C0750484
Has the subject had any systemic manifestations of WM, including hyperviscosity, neuropathy, amyloidosis, cryoglobulinemia, B symptoms.
Description

Systemic manifestations of WM, including hyperviscosity, neuropathy, amyloidosis, cryoglobulinemia, B symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0024419
UMLS CUI [2]
C0221104
UMLS CUI [3]
C0442874
UMLS CUI [4]
C0002726
UMLS CUI [5]
C0010403
UMLS CUI [6]
C1706867
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Similar models

Response Evaluation and Confirmation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
date of visit/assessment
Item
date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
subject ID
Item
subject number
text
C2348585 (UMLS CUI [1])
Item
visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
visit type
Code List
visit type
CL Item
Cycle 1 observation visit (1)
CL Item
Cycle 2 observation visit (2)
CL Item
unscheduled visit (3)
Item Group
Response Evaluation
C0521982 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
New enlarged lymph nodes
Item
Were there any new lymph nodes (>=1.5 cm) since the last assessment?
boolean
C0024204 (UMLS CUI [1,1])
C0442800 (UMLS CUI [1,2])
C0205314 (UMLS CUI [1,3])
Item
Please select the appropriate response.
integer
C0521982 (UMLS CUI [1])
Response to treatment
Code List
Please select the appropriate response.
CL Item
CR (1)
CL Item
PR (2)
CL Item
MR (13)
CL Item
SD (3)
CL Item
PD (4)
CL Item
Not evaluable  (6)
CL Item
Relapse from Complete response (10)
CL Item
Progression from a Partial response (14)
CL Item
Progression from a Minor response (15)
Item Group
Complete Response Confirmation
C0521982 (UMLS CUI-1)
C0205197 (UMLS CUI-2)
C0750484 (UMLS CUI-3)
Systemic manifestations of WM, including hyperviscosity, neuropathy, amyloidosis, cryoglobulinemia, B symptoms
Item
Has the subject had any systemic manifestations of WM, including hyperviscosity, neuropathy, amyloidosis, cryoglobulinemia, B symptoms.
boolean
C0442893 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C0221104 (UMLS CUI [2])
C0442874 (UMLS CUI [3])
C0002726 (UMLS CUI [4])
C0010403 (UMLS CUI [5])
C1706867 (UMLS CUI [6])
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