Study of Oral Venetoclax Tablets in Combination With Intravenous Obinutuzumab Injection to Assess Achievement of Best Response in Adult Participants With Chronic Lymphocytic Leukemia (FIRST)
Prospective Multi-Center Observational Study to Assess Effectiveness of Venclexta (Venetoclax) in Combination With Obinutuzumab in Population of Previously Untreated Chronic Lymphocytic Leukemia Patients in Routine Clinical Practice in Russian Federation (FIRST)
Chronic Lymphoid Leukemia (CLL) is the most common type of leukemia (cancer of blood cells) in adults affecting men more so than women. The main objective of this study is to assess the how effective venetoclax (Venclexta) in combination with Obinutuzumab is in treating Chronic Lymphocytic Leukemia (CLL). Effectiveness is assessed by achievement of best response.
Venetoclax is an approved drug developed for the treatment of CLL. Approximately 50 adult participants with previously untreated CLL will be enrolled in approximately 10 to 15 sites in Russian Federation.
Participants will receive oral venetoclax tablets in combination with intravenous (IV) Obinutuzumab as prescribed by the physician prior to enrolling in this study in accordance to the local practice and label.
There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
調査の概要
状態
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Sankt-Peterburg、ロシア連邦、191024
- Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 231127
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Tula、ロシア連邦、300053
- Tula Regional Clinical Hospital /ID# 231128
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Moskva
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Moscow、Moskva、ロシア連邦、125284
- Moscow State budget healthcare /ID# 226058
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Volgogradskaya Oblast
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Volgograd、Volgogradskaya Oblast、ロシア連邦、400138
- Regional Children's Clinical Hospital of Volgograd /ID# 238328
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Confirmed diagnosis of previously untreated Chronic Lymphocytic Leukemia (CLL).
- Participant for whom the physician has decided to initiate CLL treatment with Venetoclax combo therapy with Obinutuzumab, according to approved local label up to 4 weeks (28 days) after Obinutuzumab treatment initiation.
Exclusion Criteria:
- Contraindications to Venclexta (Venetoclax) as listed on the approved local label in Russian Federation.
- Creatinine Clearance < 30 milliLitres/minute.
- Richter syndrome or Transformation of CLL to aggressive non-Hodgkin lymphoma.
- Participating in a clinical trial with an investigative drug for CLL.
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
コホートと介入
グループ/コホート |
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Participants Treated With Venetoclax + Obinutuzumab
Participants will receive venetoclax (Venclexta) in combination with Obinutuzumab according to local label.
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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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Percentage of Participants Achieving Overall Response Rate (ORR) Best Response
時間枠:Up to approximately 36 Months
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ORR is defined as complete remission (CR) + complete remission with incomplete bone marrow recovery (CRi) + partial remission (PR) + nodular partial remission (nPR).
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Up to approximately 36 Months
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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 |
---|---|---|
Percentage of Participants Achieving Objective Response Rate (ORR)
時間枠:Up to 12 Months
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ORR is defined as CR + CRi + PR + nPR.
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Up to 12 Months
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Time to First Response
時間枠:Up to approximately 36 Months
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Time to first response is defined as number of days from first venetoclax intake to first response.
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Up to approximately 36 Months
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Time to Best Response
時間枠:Up to approximately 36 Months
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Time to best response is defined as number of days from first venetoclax intake to best response (CR, CRi, PR, nPR).
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Up to approximately 36 Months
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Duration of Response (DoR)
時間枠:Up to approximately 36 Months
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Duration of Response (DoR) is defined as number of days from first response to disease progression or death from any cause, whichever comes first.
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Up to approximately 36 Months
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Time to Next Treatment
時間枠:Up to approximately 36 Months
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Time to next treatment is defined as number of days from first venetoclax intake to first intake of next treatment including death from any cause.
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Up to approximately 36 Months
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Minimal Residual Disease (MRD)
時間枠:Up to 36 Months
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Percentage of participants achieving MRD (CLL < 10000 leucocytes) in the bone marrow, peripheral blood, either and both will be assessed.
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Up to 36 Months
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Overall Survival (OS)
時間枠:Up to 36 Months
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OS is defined as the number of days from the date of first dose to the date of the observational period end or death for all dosed participants.
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Up to 36 Months
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Progression-Free Survival (PFS)
時間枠:Up to 36 Months
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PFS is defined as the interval (in days) between the first treatment day to the first sign of disease progression or death from any cause.
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Up to 36 Months
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Number of Participants With Adverse Events (AEs)
時間枠:Up to approximately 36 Months
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
The investigator assesses the relationship of each event to the use of study.
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
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Up to approximately 36 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
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 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- P20-486
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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