Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant
2015年7月2日 更新者：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
調査の概要
研究の種類
介入
入学 (実際)
81
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
London、イギリス、EC1M 6BQ
- GSK Investigational Site
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With Objective Response
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Duration of Response
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2007年12月1日
一次修了 (実際)
2010年5月1日
研究の完了 (実際)
2014年8月1日
試験登録日
最初に提出
2008年2月13日
QC基準を満たした最初の提出物
2008年2月13日
最初の投稿 (見積もり)
2008年2月25日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年7月24日
QC基準を満たした最後の更新が送信されました
2015年7月2日
最終確認日
2015年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。