Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant
torstai 2. heinäkuuta 2015 päivittänyt: 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
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
81
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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London, Yhdistynyt kuningaskunta, EC1M 6BQ
- GSK Investigational Site
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Ofatumumab
8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg
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8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of Participants With Objective Response
Aikaikkuna: 6-month period from start of treatment (up to Week 24)
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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.
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6-month period from start of treatment (up to Week 24)
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Number of Participants Classified as Responders and Non-responders for Objective Response
Aikaikkuna: 6-month period from start of treatment (up to Week 24)
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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.
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6-month period from start of treatment (up to Week 24)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Duration of Response
Aikaikkuna: From date of start of treatment to 2 years or withdrawal
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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.
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From date of start of treatment to 2 years or withdrawal
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Progression-free Survival (PFS)
Aikaikkuna: From date of start of treatment to 2 years or withdrawal
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PFS was defined as the time from treatment start until progression or death.
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From date of start of treatment to 2 years or withdrawal
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Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy
Aikaikkuna: From date of start of treatment to 5 years or withdrawal
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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.
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From date of start of treatment to 5 years or withdrawal
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Overall Survival (OS)
Aikaikkuna: From date of start of treatment to 5 years or withdrawal
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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.
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From date of start of treatment to 5 years or withdrawal
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Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18
Aikaikkuna: Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)
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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.
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Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)
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Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
Aikaikkuna: 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)
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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.
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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)
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Number of Participants Who Experienced at Least One Adverse Event (AE)
Aikaikkuna: Time frame is from date of start of treatment to 2 years or withdrawal
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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).
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Time frame is from date of start of treatment to 2 years or withdrawal
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Percent Change From Screening in Complement (CH50) Levels
Aikaikkuna: Screening and post-baseline visits (last visit was to occur 24 months post first dose)
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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.
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Screening and post-baseline visits (last visit was to occur 24 months post first dose)
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AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion
Aikaikkuna: Visit 9 (Week 7; up to 11 months after last dose)
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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.
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Visit 9 (Week 7; up to 11 months after last dose)
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Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions
Aikaikkuna: Visit 2 (Week 0) and Visit 9 (Week 7)
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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.
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Visit 2 (Week 0) and Visit 9 (Week 7)
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Half-life (T1/2) for Ofatumumab at the Eighth Infusion
Aikaikkuna: Visit 9 (Week 7; up to 11 months after last dose)
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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.
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Visit 9 (Week 7; up to 11 months after last dose)
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Clearance (CL) of Ofatumumab at the Eighth Infusion
Aikaikkuna: Visit 9 (Week 7; up to 11 months after last dose)
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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.
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Visit 9 (Week 7; up to 11 months after last dose)
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Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion
Aikaikkuna: Visit 9 (Week 7; up to 11 months after the last dose)
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Vss is the volume of distribution at steady state of ofatumumab.
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Visit 9 (Week 7; up to 11 months after the last dose)
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
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Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Lauantai 1. joulukuuta 2007
Ensisijainen valmistuminen (Todellinen)
Lauantai 1. toukokuuta 2010
Opintojen valmistuminen (Todellinen)
Perjantai 1. elokuuta 2014
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 13. helmikuuta 2008
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 13. helmikuuta 2008
Ensimmäinen Lähetetty (Arvio)
Maanantai 25. helmikuuta 2008
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Perjantai 24. heinäkuuta 2015
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 2. heinäkuuta 2015
Viimeksi vahvistettu
Torstai 1. tammikuuta 2015
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 111776
- GEN415 (Muu tunniste: Genmab)
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