Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant
2 juli 2015 uppdaterad av: 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
81
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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London, Storbritannien, EC1M 6BQ
- GSK Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants With Objective Response
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Duration of Response
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2007
Primärt slutförande (Faktisk)
1 maj 2010
Avslutad studie (Faktisk)
1 augusti 2014
Studieregistreringsdatum
Först inskickad
13 februari 2008
Först inskickad som uppfyllde QC-kriterierna
13 februari 2008
Första postat (Uppskatta)
25 februari 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
24 juli 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juli 2015
Senast verifierad
1 januari 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 111776
- GEN415 (Annan identifierare: Genmab)
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