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

2 luglio 2015 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

81

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
      • London, Regno Unito, EC1M 6BQ
        • GSK Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Ofatumumab
8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg
Droga: Ofatumumab
8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Objective Response
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Duration of Response
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2007

Completamento primario (Effettivo)

1 maggio 2010

Completamento dello studio (Effettivo)

1 agosto 2014

Date di iscrizione allo studio

Primo inviato

13 febbraio 2008

Primo inviato che soddisfa i criteri di controllo qualità

13 febbraio 2008

Primo Inserito (Stima)

25 febbraio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

24 luglio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 luglio 2015

Ultimo verificato

1 gennaio 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 111776
  • GEN415 (Altro identificatore: Genmab)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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