0 Bewertungen
ID

41944

Beschreibung

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

Stichworte

Versionen (1)
  1. 19.02.21 19.02.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

19. Februar 2021

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

  • Neueste
  • Älteste
  • Beliebt
  • Neueste
    • Neueste
    • Älteste
    • Beliebt

    Keine Kommentare

    Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

    GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

    Englisch

    Response Evaluation and Confirmation

    1 Formulare  
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    date of visit/assessment
    Beschreibung

    date of visit/assessment

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI [2]
    C2985720 (Assessment Date)
    subject number
    Beschreibung

    subject ID

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    visit type
    Beschreibung

    visit type

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Response Evaluation
    Beschreibung

    Response Evaluation

    Alias
    UMLS CUI-1
    C0521982 (Response to treatment)
    SNOMED
    182985004
    UMLS CUI-2
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    Were there any new lymph nodes (>=1.5 cm) since the last assessment?
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0024204 (lymph nodes)
    SNOMED
    59441001
    UMLS CUI [1,2]
    C0442800 (Enlarged)
    SNOMED
    260376009
    LOINC
    LA19575-2
    UMLS CUI [1,3]
    C0205314 (New)
    SNOMED
    7147002
    LOINC
    LA9039-4
    Please select the appropriate response.
    Beschreibung

    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

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0521982 (Response to treatment)
    SNOMED
    182985004
    Complete Response Confirmation
    Beschreibung

    Complete Response Confirmation

    Alias
    UMLS CUI-1
    C0521982 (Response to treatment)
    SNOMED
    182985004
    UMLS CUI-2
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    UMLS CUI-3
    C0750484 (Confirmation)
    LOINC
    LA15290-2
    Has the subject had any systemic manifestations of WM, including hyperviscosity, neuropathy, amyloidosis, cryoglobulinemia, B symptoms.
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0442893 (Systemic disease)
    SNOMED
    56019007
    UMLS CUI [1,2]
    C0024419 (Waldenstrom Macroglobulinemia)
    SNOMED
    190818004
    UMLS CUI [2]
    C0221104 (Hyperviscosity)
    SNOMED
    64088006
    UMLS CUI [3]
    C0442874 (Neuropathy)
    SNOMED
    386033004
    UMLS CUI [4]
    C0002726 (Amyloidosis)
    SNOMED
    17602002
    LOINC
    LP209029-0
    UMLS CUI [5]
    C0010403 (Cryoglobulinemia)
    SNOMED
    30911005
    UMLS CUI [6]
    C1706867 (B-Symptoms)
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Response Evaluation and Confirmation

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Zum Seitenanfang zurückkehren 

    Hilfe

    Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

    Zum Video