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慢性リンパ性白血病（CLL）/小リンパ球性リンパ腫（SLL）の参加者の第一選択治療のためのイブルチニブとベネトクラクスとクロラムブシルとオビヌツズマブの組み合わせの研究 (GLOW)

2026年11月2日 更新者：Janssen Research & Development, LLC

慢性リンパ性白血病（CLL）/小リンパ球性リンパ腫（SLL）の被験者の第一選択治療のための、イブルチニブとベネトクラクスとクロラムブシルとオビヌツズマブの組み合わせの無作為化、非盲検、第3相試験。

The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

211

段階

  • フェーズ 3

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

  • アメリカ
    • Kentucky
      • Louisville、Kentucky、アメリカ、40207
        • Norton Cancer Institute
    • New Jersey
      • Hackensack、New Jersey、アメリカ、07601
        • John Theurer Cancer Center
    • North Carolina
      • Charlotte、North Carolina、アメリカ、28204
        • Novant Health
  • イギリス
      • Birmingham、イギリス、B9 5ST
        • Birmingham Heartlands Hospital
      • Cambridge、イギリス、CB2 0QQ
        • Addenbrookes Hospital
      • Charterhouse Square、イギリス、EC1M 6BQ
        • Queen Mary University of London
      • Glasgow、イギリス、G42 9LF
        • New Victoria Hospital
      • Leeds、イギリス、LS9 7T
        • St James's Hospital
      • Plymouth、イギリス、PL6 8DH
        • Derriford Hospital
      • Romford、イギリス、RM7 0AG
        • Barking Havering and Redbridge University Hospitals NHS Trust
      • Sheffield、イギリス、S10 2JF
        • Royal Hallamshire Hospital
  • イスラエル
      • Haifa、イスラエル、31048
        • Bnai Zion Medical Center
      • Haifa、イスラエル、34362
        • Carmel Medical Center
      • Jerusalem、イスラエル、9112001
        • Hadassah Medical Center
      • Nahariya、イスラエル、22100
        • Western Galilee Medical Center
      • Ramat Gan、イスラエル、52621
        • Sheba Medical Center
      • Tel Aviv、イスラエル、64239
        • Tel Aviv Sourasky Medical Center
  • オランダ
      • Almere Stad、オランダ、1315RA
        • Flevoziekenhuis
      • Amsterdam、オランダ、1105 AZ
        • Academic Medical Center
      • Amsterdam、オランダ、1091AC
        • OLVG
      • Delft、オランダ、2625 AD
        • Reinier de Graaf Gasthuis
      • Dordrecht、オランダ、3318 AT
        • Albert Schweitzer Ziekenhuis
      • Eindhoven、オランダ、5623 EJ
        • Catharinaziekenhuis
      • Hoofddorp、オランダ、2134 TM
        • Spaarne Gasthuis
      • Sittard-Geleen、オランダ、6162 BG
        • Zuyderland Medical Center
      • Sneek、オランダ、8601 ZK
        • Antonius hospital
      • The Hague、オランダ、2512 VA
        • MC Haaglanden
      • Tilburg、オランダ、5022 GC
        • Elisabeth zkh
  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ、T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
      • Edmonton、Alberta、カナダ、T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Hamilton、Ontario、カナダ、L8V 5C2
        • Juravinski Cancer Centre
      • Ottawa、Ontario、カナダ、K1H 8L6
        • The Ottawa Hospital - General Campus
    • Quebec
      • Montreal、Quebec、カナダ、H3T 1E2
        • Jewish General Hospital
      • Montreal、Quebec、カナダ、H1T 2M4
        • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
  • スウェーデン
      • Luelå、スウェーデン、97180
        • Sunderby Sjukhus Medicinkliniken
      • Stockholm、スウェーデン、171 76
        • Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm
  • スペイン
      • Barcelona、スペイン、08041
        • Hosp. de La Santa Creu I Sant Pau
      • Barcelona、スペイン、08036
        • Hosp Clinic de Barcelona
      • Barcelona、スペイン、08035
        • Hosp Univ Vall D Hebron
      • Madrid、スペイン、28034
        • Hospital Ramon y Cajal
      • Madrid、スペイン、28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid、スペイン、28031
        • Hosp. Univ. Infanta Leonor
      • Madrid、スペイン、28006
        • Hosp. Univ. de La Princesa
      • Madrid、スペイン、28040
        • Hosp Univ Fund Jimenez Diaz
      • Pamplona、スペイン、31008
        • Clinica Univ. de Navarra
      • Salamanca、スペイン、37007
        • Hospital Clinico Universitario Salamanca
      • Seville、スペイン、41013
        • Hosp. Virgen Del Rocio
  • チェコ
      • Brno、チェコ、625 00
        • Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika
      • Hradec Králové、チェコ、500 05
        • Fakultni nemocnice Hradec Kralove
      • Ostrava、チェコ、708 52
        • Fakultni Nemocnice Ostrava
      • Pilsen、チェコ、323 00
        • Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
      • Prague、チェコ、128 08
        • Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
  • デンマーク
      • Aalborg、デンマーク、9000
        • Aalborg University Hospital
      • Aarhus、デンマーク、8200
        • Aarhus Universitetshospital
      • Copenhagen、デンマーク、2100
        • Rigshospitalet
      • Copenhagen、デンマーク、2100
        • Rigshospitalet 1
      • Odense C、デンマーク、5000
        • Odense Universitetshospital
      • Roskilde、デンマーク、DK- 4000
        • Roskilde Sygehus
  • トルコ（Türkiye）
      • Ankara、トルコ（Türkiye）、06500
        • Gazi Universitesi Tip Fakultesi
      • Ankara、トルコ（Türkiye）、06620
        • Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
      • Istanbul、トルコ（Türkiye）、34365
        • V K V Amerikan Hastanesi
      • Izmir、トルコ（Türkiye）、35340
        • Dokuz Eylul Universitesi Tip Fakultesi
      • Samsun、トルコ（Türkiye）、55280
        • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
  • フランス
      • Clermont-Ferrand、フランス、63000
        • CHU de Clermont Ferrand
      • Lille、フランス、59000
        • Hopital Claude Huriez
      • Montpellier、フランス、34295
        • CHU Montpellier
      • Pessac、フランス、33604
        • Hopital Haut Leveque Service Maladie Du Sang
      • Reims、フランス、51100
        • Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré
      • Toulouse、フランス、31059
        • Institut Universitaire du Cancer Toulouse Oncopole
      • Tours、フランス、37044
        • CHU Bretonneau
      • Vandœuvre-lès-Nancy、フランス、54511
        • CHU-Nancy
      • Villejuif、フランス、94805
        • Institut Gustave Roussy
  • ベルギー
      • Anderlecht、ベルギー、1070
        • Institut - Jules Bordet
      • Antwerp、ベルギー、2060
        • ZNA Stuivenberg
      • Ghent、ベルギー、9000
        • Universitair Ziekenhuis Gent
      • Hasselt、ベルギー、3500
        • Virga Jessa Ziekenhuis
      • Leuven、ベルギー、3000
        • UZ Leuven Gasthuisberg
  • ポーランド
      • Chorzów、ポーランド、41-500
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
      • Koszalin、ポーランド、75-581
        • Wojewodzki Szpital Specjalistyczny im Janusza Korczaka
      • Lodz、ポーランド、93 510
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
      • Lublin、ポーランド、20-081
        • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
      • Warsaw、ポーランド、02 776
        • Instytut Hematologii i Transfuzjologii
  • ロシア
      • Moscow、ロシア、125284
        • Moscow Multidisciplinary Scientific and Clinical Center named after S P Botkin
      • Moscow、ロシア、125284
        • S.P. Botkin Moscow City Clinical Hospital
      • Nizhny Novgorod、ロシア、603126
        • Nizhniy Novgorod Region Clinical Hospital
      • Ryazan、ロシア、390039
        • Ryazan Regional Clinical Hospital
      • Saint Petersburg、ロシア、193024
        • St.-Petersburg Clinical Research Institute of Hematology and Transfusiology
      • Saint Petersburg、ロシア、197341
        • FSBIFederal Centre of Heart, Blood and Endocrinology named after V.A.Almazov MoH of the RF

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:

  • Adult participants who are: (a) greater than or equal to (>=) 65 years old or, (b) 18 to 64 years old and have at least 1 of the following:

    1. Cumulative Illness Rating Scale (CIRS) score > 6
    2. Creatinine clearance (CrCl) estimated less than (<) 70 milliliter per minute (mL/min) using Cockcroft-Gault equation

  • Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria

  • Measurable nodal disease (by computed tomography [CT]), defined as at least one lymph node > 1.5 centimeter (cm) in longest diameter

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade less than or equal to (<=) 2

  • Active CLL/SLL requiring treatment per the iwCLL criteria

Exclusion Criteria:

  • Prior anti-leukemic therapy for CLL or SLL
  • Presence of deletion of the short arm of chromosome 17 (del17p) or known TP53 mutation detected at a threshold of >10 percent (%) variable allele frequency (VAF)
  • Major surgery within 4 weeks of first dose of study treatment
  • Known bleeding disorders (example, von Willebrand's disease or hemophilia)
  • Central nervous system (CNS) involvement or suspected Richter's syndrome

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：ランダム化
  • 介入モデル：並列代入
  • 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
実験的：Treatment Arm A: Ibrutinib and Venetoclax (I+VEN)

Participants will initially receive ibrutinib (420 mg [milligrams]/day) for 3 cycles. Venetoclax dose ramp up (from 20 to 400 mg over 5 weeks) will begin at Cycle 4 and the combination of ibrutinib and venetoclax will be given for 12 cycles (each cycle is equivalent to 28 days). Participants who subsequently develop progressive disease may enter to Subsequent Therapy Phase to receive single-agent ibrutinib until disease progression or unacceptable toxicity.
薬：Ibrutinib

Participants will receive ibrutinib 420 mg orally once daily up to 15 cycles.

薬：Venetoclax

Participants will receive venetoclax in combination with ibrutinib for a total of 12 cycles, beginning at Cycle 4. For the first 5 weeks of venetoclax treatment, the treatment dose will be ramped up from 20 to 400 mg.

薬：Ibrutinib (as Subsequent Therapy)

Participants will receive ibrutinib 420 mg orally once daily until disease progression or unacceptable toxicity during the subsequent therapy phase.
アクティブコンパレータ：Treatment Arm B: Chlorambucil and Obinutuzumab (G-Clb)

Participants will receive chlorambucil and obinutuzumab (G-Clb) for 6 cycles. Participants will receive obinutuzumab, 1000 mg intravenously (IV) on Days 1, 8 and 15 of Cycle 1, and on Day 1 of Cycles 2 to 6 and chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight, on Days 1 and 15 of Cycles 1 to 6. Participants who subsequently develop progressive disease may enter to Subsequent Therapy Phase to receive single-agent ibrutinib until disease progression or unacceptable toxicity.
薬：Ibrutinib (as Subsequent Therapy)

Participants will receive ibrutinib 420 mg orally once daily until disease progression or unacceptable toxicity during the subsequent therapy phase.

薬：Chlorambucil

Participants will receive chlorambucil at a dose of 0.5 mg/kg body weight on Days 1 and 15 of Cycles 1 to 6.

薬：Obinutuzumab

Participant will receive obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, and Day 1 of Cycles 2 to 6.

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
Progression Free Survival (PFS)
時間枠：Up to 2 years 10 months

PFS: time between date of randomization and date of disease progression, as assessed by IRC, or date of death due to any cause, whichever occurs first, regardless of use of subsequent anti-cancer therapy prior to PD or death using iWCLL2008 criteria : New enlarged lymph nodes >15 mm, new hepatomegaly or splenomegaly, or other organ infiltrates, bone lesion, ascites or pleural effusion due to CLL; >=50% increase in longest diameter (LDi) from nadir in existing lymph node (LDi >15 mm) or >=50% increase from nadir in sum of diameters of multiple nodes (and at least 1 node with LDi >15 mm); >=50% increase from nadir in enlargement of liver/spleen; >=50% increase from baseline in lymphocyte count (ALC; to >=5*10^9/L); or >=50% increase from nadir in ALC in >=2 serial assessments if ALC is >=30000*10^9/L and lymphocyte doubling time is rapid unless considered treatment-related lymphocytosis; new cytopenia attributable to CLL; transformation to more aggressive histology.
Up to 2 years 10 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Minimal Residual Disease (MRD) Negative Rate
時間枠：Up to 2 years 10 months

MRD-negative rate is defined as the percentage of participants who achieved MRD-negative status (that is, less than [<] 1 chronic lymphocytic leukemia (CLL) cell per 10,000 leukocytes or <0.01 percentage [%]) in the bone marrow as assessed by next-generation sequencing (NGS). Participants with missing MRD data were considered MRD positive.
Up to 2 years 10 months
Complete Response Rate (CRR)
時間枠：Up to 2 years 10 months

Complete response rate is defined as the percentage of participants who achieved complete response or complete response with an incomplete marrow recovery (CRi) on or prior to initiation of subsequent anti-leukemic therapy per the IRC assessment. International Workshop on Chronic Lymphocytic Leukemia (iWCLL) 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/liter (L), platelets >100*10^9/L, Hgb >11 gram per deciliter (g/dL), absolute lymphocyte count <4000/microliter (mcL) and normocellular bone marrow with <30% lymphocytes and no B lymphoid nodules; CRi- CR with incomplete recovery of bone marrow.
Up to 2 years 10 months
Overall Response Rate (ORR)
時間枠：Up to 2 years 10 months

ORR: percentage of participants who achieved best overall response of either CR, CRi, nodular PR (nPR) and partial response (PR). iWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/liter (L), platelets >100*10^9/L, Hgb >11 g/dL and ALC <4000/mcL, normocellular bone marrow with <30% lymphocytes and no B lymphoid nodules; CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but bone marrow biopsy shows B-lymphoid nodules (reflecting residual disease); PR-2 of following when abnormal at baseline: >=50% decrease in ALC, >=50% decrease in sum of products of multiple nodes, >=50% decrease in enlargement of spleen or liver; and 1 of following: neutrophils >1.5*10^9/L, Platelets >100*10^9/L and Hgb>11 g/dL or >=50% improvement over baseline in any of these; 50% reduction in bone marrow infiltrates or B lymphoid nodules; no new enlarged nodes or new hepatosplenomegaly.
Up to 2 years 10 months
Overall Survival (OS)
時間枠：Up to 4 years 10 months

OS is defined as the time from date of randomization to date of death from any cause.
Up to 4 years 10 months
Duration of Response (DOR)
時間枠：Up to 2 years 10 months

DOR is defined as the interval between the date of initial documentation of a response including partial response with lymphocytosis (PRL) and the date of first documented evidence of PD or death or date of censoring per the IRC assessment. iWCLL 2008 criteria for PD: New enlarged nodes >1.5 cm, new hepatomegaly or splenomegaly, or other organ infiltrates; >= 50% increase from nadir in existing lymph node or >=50% increase from nadir in sum of product of diameters of multiple nodes; >=50% increase from nadir in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b or platelets) attributable to CLL; transformation to a more aggressive histology.
Up to 2 years 10 months
Time-to-Next Treatment
時間枠：Up to 2 years 10 months

Time-to-next treatment was measured from the date of randomization to the start date of any subsequent anti-leukemic therapy.
Up to 2 years 10 months
Time to Worsening as Measured by Using EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L)
時間枠：Up to 2 years 10 months

Time to worsening= time interval (months) from randomization to first observation of deterioration. EQ-5D-5L consists of a 5-item descriptive system and the EuroQol visual analog scale (EQ-5D VAS). EQ-5D-VAS self-rating records respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Worsening is defined as a decrease of >= 7 points (on a 0-100 scale).

EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe participant's current health state. Responses for 5 dimensions are combined into a 5-digit number describing respondents health state that can be converted into a single index value or utility score (using the United Kingdom weights), ranging from -1 to 1, where lower scores indicate a worse health status. Worsening is defined as a decrease of >=0.08 points (on a 0-1 scale).
Up to 2 years 10 months
Time to Worsening Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30)
時間枠：Up to 2 years 10 months

Time to worsening= time interval from randomization to first observation of deterioration. EORTC QLQ-C30 includes 30 separate items: 5 functional scales (physical, role, emotional, cognitive, and social Functioning), 1 global health status (GHS) and QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each item, except GHS, is answered on 4-point scale (1=not at all to 4=very much) and GHS is measured on 1-7 scale: 1=very poor and 7=excellent. Scores derived using validated scoring algorithms as per EORTC QLQ-C30 Manual and linearly transformed in a range from 0-100. For functional and global QoL scales, higher scores=better level of functioning/QoL. For symptom-oriented scales, higher score=more severe symptoms. Worsening in functional and global health scores=decrease of >=10 points (on 0-100 scale) and in symptom scores=increase of >=10 points (on 0-100 scale).
Up to 2 years 10 months
Time to Worsening and Time to Improvement as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score
時間枠：Up to 2 years 10 months

Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). Time to Worsening is defined as time interval (months) from randomization to first observation of deterioration. Worsening is defined as a decrease >= 3 points (on a 0-52 scale). Time to improvement is defined as the time interval (months) from randomization to the first observation of improvement. Improvement is defined as an increase >=3 points (on a 0-52 scale).
Up to 2 years 10 months
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
時間枠：Up to 4 years 10 months

An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to 4 years 10 months
Number of Participants With Abnormal Clinical Laboratory Findings
時間枠：Up to 4 years 10 months

Number of participants with abnormal clinical laboratory findings (hematology and serum chemistry) were reported.
Up to 4 years 10 months
Percentage of Participants With Sustained Hemoglobin Improvement
時間枠：Up to 2 years 10 months

Sustained hemoglobin improvement is defined as the percentage of participants who achieved an increase in hemoglobin levels from baseline by >= 2 grams per deciliter (g/dL) and lasts for at least 56 days without blood transfusion or growth factors.
Up to 2 years 10 months
Percentage of Participants With Sustained Platelet Improvement
時間枠：Up to 2 years 10 months

Sustained platelet improvement is defined as the percentage of participants who achieved an increase in platelet levels from baseline by >= 50% and lasts for at least 56 days without blood transfusion or growth factors.
Up to 2 years 10 months
Plasma Concentration of Ibrutinib and Venetoclax
時間枠：Ibrutinib: Pre-dose-Day 1 of Cycles 2, 3, 5 and 6 (each cycle is defined as 28 days), Venetoclax: Pre-dose-Day 1 of Cycles 5 and 6

Plasma concentrations of ibrutinib and venetoclax were determined by validated liquid chromatography-tandem mass spectrometry.
Ibrutinib: Pre-dose-Day 1 of Cycles 2, 3, 5 and 6 (each cycle is defined as 28 days), Venetoclax: Pre-dose-Day 1 of Cycles 5 and 6

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Janssen Research & Development, LLC

協力者

Pharmacyclics LLC.

捜査官

  • スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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 (実際)

2018年4月17日

一次修了 (実際)

2021年2月26日

研究の完了 (推定)

2029年4月5日

試験登録日

最初に提出

2018年3月6日

QC基準を満たした最初の提出物

2018年3月6日

最初の投稿 (実際)

2018年3月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月3日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • CR108428
  • 2017 (米国 NIH グラント/契約)
  • 2017-004699-77 (EudraCT番号)
  • 54179060CLL3011 (その他の識別子：Janssen Research & Development, LLC)

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

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

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