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ID

41944

Beskrivning

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.

Länk

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

Nyckelord

Versioner (1)
  1. 19/02/21 19/02/21 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

19 febbraio 2021

DOI

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Licens

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

    Engelsk

    Response Evaluation and Confirmation

    1 Formulär  
    Administrative Data
    Beskrivning

    Administrative Data

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

    date of visit/assessment

    Datatyp

    date

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

    subject ID

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    visit type
    Beskrivning

    visit type

    Datatyp

    text

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

    Response Evaluation

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

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

    Datatyp

    boolean

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

    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

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0521982
    Complete Response Confirmation
    Beskrivning

    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.
    Beskrivning

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

    Datatyp

    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
    Tillbaka till toppen

    Similar models

    Response Evaluation and Confirmation

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])
    Tillbaka till toppen 

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