BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
A Phase I, Open-Label, Dose-Escalation Trial With BI 836826 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma of B Cell Origin
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Berlin、ドイツ、12200
- Charité - Universitätsmedizin Berlin
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Dresden、ドイツ、01307
- Universitätsklinikum Carl Gustav Carus Dresden
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Frankfurt am Main、ドイツ、60590
- Universitätsklinikum Frankfurt
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Göttingen、ドイツ、37075
- Universitätsmedizin Göttingen, Georg-August-Universität
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Hamburg、ドイツ、20099
- Asklepios Klinik St. Georg
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Heidelberg、ドイツ、69120
- Universitätsklinikum Heidelberg
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Jena、ドイツ、07740
- Universitätsklinikum Jena
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Ulm、ドイツ、89081
- Universitätsklinikum Ulm
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Marseille Cedex 09、フランス、13273
- INS Paoli-Calmettes
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Pierre Bénite、フランス、69495
- HOP Lyon Sud
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Seoul、大韓民国、135-710
- Samsung Medical Center
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Seoul、大韓民国、110-744
- Seoul National University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:
- Patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin (mature B cell lymphoma according to WHO) not considered candidates for intensive anti-lymphoma therapy
- Patients must have either aggressive NHL and received at least one prior anti-CD20 containing immunochemotherapy or indolent NHL and received anti-CD20 therapy and at least two prior therapies
- Measurable disease on computed tomography (CT) scan with involvement of one clearly demarcated lesion =2 cm or two or more clearly demarcated lesions of >1.5 cm at longest diameter (this criterion applies only for the expansion cohort)
- Relapse or progression of disease with an indication for therapy as per investigator's judgement
- Life expectancy of =3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Exclusion criteria:
- Primary central nervous system (CNS) lymphoma or known CNS involvement
- Prior history of malignancy other than a mature B cell neoplasm according to WHO classification (except basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the uterine cervix or breast treated with curative therapy) unless the subject has been free of disease and without treatment for at least 5 years
- Last chemotherapy <4 weeks prior to visit 1
- Last anti-CD20 therapy (non-radiolabelled) <4 weeks prior to visit 1
- Last corticosteroid <2 weeks prior to visit 1 unless the dose is less or equal of 10 mg/day prednisolone or equivalent
- High-dose therapy with stem cell support <6 months prior to visit 1
- Radio-immunotherapy <3 months prior to visit 1
研究計画
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
- 介入モデル：順次割り当て
- 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：Patients with relapsed or refractory NHL
Adult patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin after at least two prior treatments
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Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion
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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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Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients
時間枠：From the first administration of trial medication to 7 days after the second administration, upto 36 days
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The primary objective of the dose-escalation part of this study was to determine the MTD of BI 836826 in caucasian patients.
The MTD was to be defined on the basis of DLTs observed during the first 2 weeks of the 1st treatment course.
In case of a delay of the second administration, evaluation of DLT was to be prolonged to 7 days after the second administration..
A DLT was defined as any drug-related non-haematological Adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher, except Infusion-related reaction (IRRs) associated with the administration of BI 836826.
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From the first administration of trial medication to 7 days after the second administration, upto 36 days
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Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients
時間枠：From the first administration of trial medication to 7 days after the second administration, up to 36 days
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Number of subjects with Dose Limiting Toxicities (DLT) in first Cycle during the MTD evaluation period in caucasian patients with relapsed or refractory Non-Hodgkin lymphoma (NHL).
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From the first administration of trial medication to 7 days after the second administration, up to 36 days
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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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Tumour Size Reduction
時間枠：Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
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Tumour size reduction (lymph nodes, spleen, & liver nodules) defined as best percentage change from baseline in sum of products of diameter (SPD).
Negative value represents decrease in tumour size, & positive value represents an increase in size.
The tumour size of lymph nodes was to be measured as SPD of 2 perpendicular dimensions for up to 6 indicator lesions identified at baseline CT scan.
Spleen & liver were to be described if considered enlarged at baseline by physical examination or CT scan.
If nodules present in spleen &/or liver, was to be measured in 2 perpendicular dimensions.
Median, 25th & 75th percentiles are calculated from unadjusted Kaplan-Meier curve for each treatment cohort.
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Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
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Best Overall Response Based on All Assessment
時間枠：Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)
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Best overall response was best response at any of CT scans and investigator assesment (incase the recent CT scan was not available). Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:
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Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)
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Best Overall Response Based on Imaging Data
時間枠：Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
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Best overall response based on imaging data. Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:
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Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
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Progression Free Survival (PFS)
時間枠：from first treatment until disease progression or death from any cause, up to 12 months.
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PFS was defined as the time from first treatment with BI 836826 until disease progression or death from any cause. For disease progression one of the following criteria was required: • Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort. |
from first treatment until disease progression or death from any cause, up to 12 months.
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Failure Free Survival (FFS)
時間枠：from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.
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FFS was defined as the time from first treatment with BI 836826 until objective disease progression, death, or start of next Non-Hodgkin lymphoma (NHL) therapy.For disease progression one of the following criteria was required: • Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort. |
from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.
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協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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