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Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant

2. Juli 2015 aktualisiert von: GlaxoSmithKline

An Open-label, Single-arm. Multi-center Phase 2 Trial With Ofatumumab in Patients With Relapsed/Progressive Diffuse Large B-Cell Lymphoma (DLBCL) Ineligible for Transplant or Relapse/Progression After Autologous Transplant

The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

81

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

Patients with DLBCL

  • and relapse after complete remission or disease progression after partial remission who are ineligible for autologous stem cell transplantation
  • and relapse after complete remission or disease progression after partial remission following autologous stem cell transplantation.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Ofatumumab
8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg
Arzneimittel: Ofatumumab
8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Objective Response
Zeitfenster: 6-month period from start of treatment (up to Week 24)
Objective response of ofatumumab treatment was assessed according to the "revised response criteria for malignant lymphoma." Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease.
6-month period from start of treatment (up to Week 24)
Number of Participants Classified as Responders and Non-responders for Objective Response
Zeitfenster: 6-month period from start of treatment (up to Week 24)
According to the "revised response criteria for malignant lymphoma," responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD). Participants not evaluable (NE) were also considered to be non-responders. PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline. SD is defined as failure to attain CR, PR, or PD.
6-month period from start of treatment (up to Week 24)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Duration of Response
Zeitfenster: From date of start of treatment to 2 years or withdrawal
The duration of response was defined as the time from the initial response (CR or PR) to the time of relapse, progression, or death. If the participant was lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.
From date of start of treatment to 2 years or withdrawal
Progression-free Survival (PFS)
Zeitfenster: From date of start of treatment to 2 years or withdrawal
PFS was defined as the time from treatment start until progression or death.
From date of start of treatment to 2 years or withdrawal
Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy
Zeitfenster: From date of start of treatment to 5 years or withdrawal
Time to next DLBCL therapy was defined as the time from the first infusion date to the time of the first administration of the next DLBCL treatment other than ofatumumab. If the participants were lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.
From date of start of treatment to 5 years or withdrawal
Overall Survival (OS)
Zeitfenster: From date of start of treatment to 5 years or withdrawal
Overall survival is defined as the time from first infusion to death. Overall survival was a secondary endpoint in the study. However, since many participants withdrew from the study after developing disease progression overall survival could not be reliably estimated.
From date of start of treatment to 5 years or withdrawal
Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18
Zeitfenster: Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)
HAHA are indicators of immune response to ofatumumab. Blood samples were collected from participants at Visits 1, 12, 13, 14, and 18 and analyzed in batches. The number of participants with positive results at each visit is reported.
Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
Zeitfenster: Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36)
B cells (CD45+CD19+ and CD45+CD20+) were measured in peripheral blood samples by flow cytometry. Percent change from Baseline = (value at the indicated visits minus the value at Baseline divided by the value at Baseline) * 100.
Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36)
Number of Participants Who Experienced at Least One Adverse Event (AE)
Zeitfenster: Time frame is from date of start of treatment to 2 years or withdrawal
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. The protocol-defined AE reporting period was from the first infusion (Visit 2/Week 0) to Visit 18 (Month 24 of follow-up) or time of withdrawal (treatment and follow-up).
Time frame is from date of start of treatment to 2 years or withdrawal
Percent Change From Screening in Complement (CH50) Levels
Zeitfenster: Screening and post-baseline visits (last visit was to occur 24 months post first dose)
CH50 was mistakenly registered as an outcome measure with the protocol record. Samples were not collected, and no analysis will take place. Thus, no data will be reported for this outcome measure.
Screening and post-baseline visits (last visit was to occur 24 months post first dose)
AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion
Zeitfenster: Visit 9 (Week 7; up to 11 months after last dose)
AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is the AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is the AUC from the start of infusion extrapolated to infinity.
Visit 9 (Week 7; up to 11 months after last dose)
Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions
Zeitfenster: Visit 2 (Week 0) and Visit 9 (Week 7)
Cmax is defined as the maximum concentration of drug in serum samples. Ctrough is defined as the minimum observed concentration prior to the start of the next dose. No drug is present prior to the first infusion; therefore, there are no Ctrough results for the first dose.
Visit 2 (Week 0) and Visit 9 (Week 7)
Half-life (T1/2) for Ofatumumab at the Eighth Infusion
Zeitfenster: Visit 9 (Week 7; up to 11 months after last dose)
t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.
Visit 9 (Week 7; up to 11 months after last dose)
Clearance (CL) of Ofatumumab at the Eighth Infusion
Zeitfenster: Visit 9 (Week 7; up to 11 months after last dose)
CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time.
Visit 9 (Week 7; up to 11 months after last dose)
Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion
Zeitfenster: Visit 9 (Week 7; up to 11 months after the last dose)
Vss is the volume of distribution at steady state of ofatumumab.
Visit 9 (Week 7; up to 11 months after the last dose)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

GlaxoSmithKline

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Dezember 2007

Primärer Abschluss (Tatsächlich)

1. Mai 2010

Studienabschluss (Tatsächlich)

1. August 2014

Studienanmeldedaten

Zuerst eingereicht

13. Februar 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Februar 2008

Zuerst gepostet (Schätzen)

25. Februar 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

24. Juli 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juli 2015

Zuletzt verifiziert

1. Januar 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 111776
  • GEN415 (Andere Kennung: Genmab)

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