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Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma

27 oktober 2017 bijgewerkt door: Pfizer

A Phase 2 Study Of Inotuzumab Ozogamicin (Cmc-544) In Subjects With Indolent Non-hodgkin's Lymphoma (Nhl) That Is Refractory To Or Has Relapsed After Rituximab And Chemotherapy Or Radioimmunotherapy

The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

81

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • België
      • Gent, België, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, België, 3000
        • Universitaire Ziekenhuizen UZ Gasthuisberg
      • Wilrijk, België, 2610
        • Oncologisch Centrum GZA - Location St. Augustinus
  • Duitsland
      • Berlin, Duitsland, 10117
        • Charité Campus Mitte
      • Berlin, Duitsland, 13353
        • Charité Berlin-Campus Virchow-Klinikum
  • Hongarije
      • Debrecen, Hongarije, 4012
        • Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Belgyogyaszati Intezet,
      • Kaposvar, Hongarije, 7400
        • Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
  • Hongkong
      • Shatin, N.T., Hongkong
        • The Chinese University of Hong Kong, Prince of Wales Hospital
  • Japan
      • Aichi, Japan, 466-8650
        • Nagoya Daini Red Cross Hospital
      • Aichi, Japan, 460-0003
        • EPMint Co., Ltd
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Fukuoka, Japan
        • National Hp. Org. Kyushu Medical Center
      • Kanagawa, Japan, 259-1193
        • Tokai University Hospital
      • Tokyo, Japan, 135-8550
        • Cancer Inst. Hp. of Japanese Foundation for Cancer Research
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
  • Korea, republiek van
    • Korea
      • Seoul, Korea, Korea, republiek van, 135-710
        • Samsung Medical Center
  • Nederland
      • Rotterdam, Nederland, 3015 CE
        • Erasmus Medisch Centrum
      • Rotterdam, Nederland, 3015 GD
        • Erasmus MC Apotheek
  • Singapore
      • Singapore, Singapore, 169 608
        • Singapore General Hospital
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35294-3300
        • University of Alabama Birmingham
      • Birmingham, Alabama, Verenigde Staten, 35294-3330
        • University of Alabama at Birmingham
      • Birmingham, Alabama, Verenigde Staten, 35294
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • California
      • Loma Linda, California, Verenigde Staten, 92354
        • Loma Linda University Medical Center
      • Loma Linda, California, Verenigde Staten, 92350 1700
        • Loma Linda University Cancer Center
      • Loma Linda, California, Verenigde Staten, 92354
        • Loma Linda University Cancer Center #5
      • Mission Hills, California, Verenigde Staten, 91345
        • Facey Medical Group
      • Mission Hills, California, Verenigde Staten, 91345
        • Providence Holy Cross
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60612
        • Rush University Medical Center
    • Minnesota
      • Saint Louis Park, Minnesota, Verenigde Staten, 55426
        • Park Nicollet Frauenshuh Cancer Center
    • Missouri
      • Saint Louis, Missouri, Verenigde Staten, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, Verenigde Staten, 63110
        • Barnes-Jewish Hospital
    • New Jersey
      • Hackensack, New Jersey, Verenigde Staten, 07601
        • Hackensack University Medical Center
      • Hackensack, New Jersey, Verenigde Staten, 07601
        • John Theurer Cancer Center
    • New York
      • Hawthorne, New York, Verenigde Staten, 10532
        • New York Medical College
    • Pennsylvania
      • Allentown, Pennsylvania, Verenigde Staten, 18103-6205
        • Quest Diagnostics
      • Carlisle, Pennsylvania, Verenigde Staten, 17015
        • Carlisle Regional Medical Center Lab
      • Hershey, Pennsylvania, Verenigde Staten, 17033-0850
        • Penn State Milton S. Hershey Medical Center
      • Lewistown, Pennsylvania, Verenigde Staten, 17044
        • Lewistown Hospital
      • Philadelphia, Pennsylvania, Verenigde Staten, 19111-2497
        • Fox Chase Cancer Center
      • State College, Pennsylvania, Verenigde Staten, 16803
        • CMSA Medical Lab
    • Texas
      • Houston, Texas, Verenigde Staten, 77030-4009
        • University of Texas, MD Anderson Cancer Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies.
  • Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy.
  • Measurable disease with adequate bone marrow function, renal and hepatic function

Exclusion Criteria:

  • History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
  • Prior allogeneic hematopoietic stem cell transplant (HSCT).
  • Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: inotuzumab ozogamicin
Geneesmiddel: Inotuzumab Ozogamicin (CMC-544)
Administered intravenously at 1.8 mg/m2 every 4 weeks for a planned 4 - 8 cycles
Andere namen:
  • inotuzumab ozogamicin

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL
Tijdsspanne: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 cm in their greatest transverse diameter [GTD] for nodes more than [>]1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by greater than or equal to [≥]50% in the SPD or GTD (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHL
Tijdsspanne: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or greatest transverse diameter (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHL
Tijdsspanne: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHL
Tijdsspanne: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Duration of Response in Participants With Indolent NHL
Tijdsspanne: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Duration of response was measured from the first date of response until the first date that the objective progression of disease (PD) or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL
Tijdsspanne: 6, 12 and 24 months
Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
6, 12 and 24 months
Duration of Response in Participants With Follicular NHL
Tijdsspanne: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL
Tijdsspanne: 6, 12 and 24 months
Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
6, 12 and 24 months
Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in Participants With Indolent NHL
Tijdsspanne: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Indolent NHL
Tijdsspanne: 6, 12 and 24 months
Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
6, 12 and 24 months
Kaplan-Meier Estimate of the PFS in Participants With Follicular NHL
Tijdsspanne: Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier Estimate of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Follicular NHL
Tijdsspanne: 6, 12 and 24 months
Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
6, 12 and 24 months
Kaplan-Meier Estimate of the Overall Survival (OS) in Participants With Indolent NHL
Tijdsspanne: Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.
Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier Estimates of the Probability of Survival at 6, 12 and 24 Months in Participants With Indolent NHL
Tijdsspanne: 6, 12 and 24 months
Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.
6, 12 and 24 months
Kaplan-Meier Estimate of the OS in Participants With Follicular NHL
Tijdsspanne: Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.
Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier Esitmates of the Probability of Survival at 6, 12 and 24 Months in Participants With Follicular NHL
Tijdsspanne: 6, 12 and 24 months
Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.
6, 12 and 24 months
Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax)
Tijdsspanne: Cycle 1: pre-dose, 1 hour; Cycle 3 & 4: pre-dose, 1, 3, 48, 168 hours; Cycle 6 (if applicable): pre-dose; end of treatment: during clinic visit
Triplicate 12-lead electrocardiogram (ECG) measurements were performed approximately 2 minutes apart. ECG assessments were pre-specified in the protocol to be time-matched with selected pharmacokinetic (PK) samples in order to conduct a concentration-QTc analysis. A study-specific QT correction factor was estimated using the un-averaged triplicate data and was used to calculate the study-specific corrected QT (QTcS). QTcS interval versus serum concentrations were modeled using a population analysis approach to identify potential effects of total calicheamicin exposure. Results for drug effects were based on the median Cmax for total calicheamicin across all participants: median Cmax was 61.3 ng/mL
Cycle 1: pre-dose, 1 hour; Cycle 3 & 4: pre-dose, 1, 3, 48, 168 hours; Cycle 6 (if applicable): pre-dose; end of treatment: during clinic visit
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
Tijdsspanne: Protocol reporting period: from informed consent to at least 28 days after the last dose.
Includes all TEAEs: any event that emerged after the first dose of the study treatment during the treatment period that was absent before administration of any study treatment, or worsened during the treatment period relative to the pre-treatment state.
Protocol reporting period: from informed consent to at least 28 days after the last dose.
Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population)
Tijdsspanne: Screening; Cycle 1: pre-dose & 1 hour; Cycles 3 and 4: pre-dose, 1, 3, 48, and 168 hours; Cycle 6: pre-dose; end of treatment: 28 to 56 days post-last dose.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Maximum QTcF was categorized as less than or equal to (≤) 450 msec, >450 msec to ≤480 msec, >480 msec to ≤500 msec and >500 msec. Participants are reported only once under the maximum QTcF interval observed at any of the time-points. Maximum increase from baseline was categorized as <30 msec, ≥30 to <60 msec (borderline) and ≥60 msec (prolonged) were summarized.
Screening; Cycle 1: pre-dose & 1 hour; Cycles 3 and 4: pre-dose, 1, 3, 48, and 168 hours; Cycle 6: pre-dose; end of treatment: 28 to 56 days post-last dose.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pfizer

Medewerkers

UCB Pharma

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 juli 2009

Primaire voltooiing (Werkelijk)

10 januari 2012

Studie voltooiing (Werkelijk)

27 juni 2013

Studieregistratiedata

Eerst ingediend

24 maart 2009

Eerst ingediend dat voldeed aan de QC-criteria

24 maart 2009

Eerst geplaatst (Schatting)

25 maart 2009

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 oktober 2017

Laatste update ingediend die voldeed aan QC-criteria

27 oktober 2017

Laatst geverifieerd

1 oktober 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 3129K7-2001
  • B1931007 (Andere identificatie: Alias Study Number)
  • 2008-001635-34 (EudraCT-nummer)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Inotuzumab Ozogamicin (CMC-544)

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Voorwaarden

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