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A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL

2020年5月26日 更新者：Hoffmann-La Roche

A Phase Ib/II, Open-Label Study Evaluating the Safety, Efficacy and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL

This is a multicenter, open-label, dose-finding study of venetoclax administered orally in combination with rituximab (R) or obinutuzumab (G) and standard doses of cyclophosphamide, doxorubicin, vincristine and oral prednisone (CHOP) in participants with Non-Hodgkin's Lymphoma (NHL). The study consisted of 2 stages: a dose-finding Phase Ib stage and a Phase II expansion stage. In the Phase I portion of the study, participants were randomized to one of 2 treatment arms venetoclax in combination with R-CHOP (Arm A) and venetoclax in combination with G-CHOP (Arm B) and explored the doses of venetoclax in combination with R-CHOP and G-CHOP. The maximum tolerated dose (MTD) of venetoclax in combination with R-CHOP and G-CHOP was determined during the dose-finding stage. For the Phase II portion of the study, the venetoclax dose for venetoclax + R-CHOP was on a non-continuous dosing schedule as determined by the Phase Ib portion of the study based on safety and tolerability observed in participants treated in the dose escalation portion of the study. On 17 July 2016, Roche/Genentech as the sponsor of Study BO21005 (Goya study), a Phase III study that evaluated G CHOP versus R-CHOP in 1L DLBCL, informed through a press release that the primary endpoint of investigator-assessed PFS was not met. Given these results, Arm B (venetoclax + G-CHOP) was not expanded in Phase II in patients who are first-line with DLBCL.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

267

段階

  • フェーズ2
  • フェーズ 1

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
    • California
      • Fullerton、California、アメリカ、92835
        • St. Jude Heritage Healthcare
      • Los Angeles、California、アメリカ、90095
        • UCLA Jonsson Comprehensive Cancer Center
      • Santa Maria、California、アメリカ、93454
        • Central Coast Medical Oncology
    • Missouri
      • Saint Louis、Missouri、アメリカ、63129
        • The West Clinici
    • New Jersey
      • Hackensack、New Jersey、アメリカ、07601
        • Hackensack University Medical Center; WFAN - Imus Pediatric Center
    • New Mexico
      • Farmington、New Mexico、アメリカ、87401
        • San Juan Oncology Associates
    • New York
      • New York、New York、アメリカ、10065
        • Memorial Sloan-Kettering Cancer Center
      • Rochester、New York、アメリカ、14642
        • Uni of Rochester Medical Center; Wilmot Cancer Center, Pharmacy Department
    • Tennessee
      • Nashville、Tennessee、アメリカ、37203
        • Tennessee Oncology
  • イタリア
    • Campania
      • Napoli、Campania、イタリア、80131
        • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
    • Liguria
      • Genova、Liguria、イタリア、16132
        • Azienda Ospedaliero Universitaria San Martino
    • Piemonte
      • Torino、Piemonte、イタリア、10126
        • Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
    • Sicilia
      • Palermo、Sicilia、イタリア、90127
        • Azienda Ospedaliera Vincenzo Cervello
    • Toscana
      • Pisa、Toscana、イタリア、56100
        • Azienda Ospedaliero Universitaria Pisana; U.O. Farmaceutica
  • オランダ
      • Amsterdam、オランダ、1081 HV
        • Amsterdam UMC location VUMC
      • Rotterdam、オランダ、3015 GD
        • Erasmus Medisch Centrum
      • Utrecht、オランダ、3508 GA
        • UMC Utrecht
  • オーストラリア
    • New South Wales
      • Concord、New South Wales、オーストラリア、2139
        • Concord Repatriation General Hospital
    • Queensland
      • Woolloongabba、Queensland、オーストラリア、4102
        • Princess Alexandra Hospital
    • Victoria
      • Melbourne、Victoria、オーストラリア、3000
        • Peter MacCallum Cancer Centre-East Melbourne
      • Parkville、Victoria、オーストラリア、3050
        • Royal Melbourne Hospital
  • オーストリア
      • Salzburg、オーストリア、5020
        • Lkh - Universitatsklinikum Der Pmu Salzburg
      • Wien、オーストリア、1090
        • Medizinische Universität Wien
  • カナダ
      • Quebec、カナダ、G1J 1Z4
        • CHU de Quebec - Hôpital de l' Enfant Jésus
    • Alberta
      • Edmonton、Alberta、カナダ、T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Kelowna、British Columbia、カナダ、V1Y 5L3
        • BC Cancer Agency, CSI
      • Vancouver、British Columbia、カナダ、V5Z 4E6
        • BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency
    • Quebec
      • Montréal、Quebec、カナダ、H3T 1E2
        • Jewish General Hospital; Research Unit
  • スペイン
      • Barcelona、スペイン、08003
        • Hospital Del Mar
      • Barcelona、スペイン、08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona、スペイン、08907
        • ICO l´Hospitalet - Hospital Duran i Reynals; Hematology
      • Madrid、スペイン、28034
        • Hospital Universitario Ramon y Cajal
      • Madrid、スペイン、280146
        • Hospital Universitario La Paz
      • Salamanca、スペイン、37007
        • Hospital Universitario De Salamanca
  • チェコ
      • Brno、チェコ、613 00
        • Fakultni nemocnice Brno
      • Hradec Kralove、チェコ、500 05
        • Fakultni nemocnice Hradec Kralove
      • Ostrava - Poruba、チェコ、708 52
        • Fakultni Nemocnice Ostrava
      • Praha 2、チェコ、128 08
        • Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
  • ハンガリー
      • Budapest、ハンガリー、1122
        • Országos Onkológiai Intézet
      • Budapest、ハンガリー、1083
        • Semmelweis Egyetem
      • Debrecen、ハンガリー、4032
        • Debreceni Egyetem; Belgyogyaszati Klinika Hematologiai Tanszek
  • フランス
      • Creteil、フランス、94010
        • Hopital Henri Mondor, Unite Hemopathies lymphoides
      • La Roche sur Yon、フランス、85025
        • Centre Hospitalier Departemental Les Oudairies
      • Le Mans、フランス、72015
        • Clinique Victor Hugo; Pharmacie
      • Lille、フランス、59037
        • Hopital Claude Huriez - CHU Lille
      • Montpellier、フランス、34295
        • Hopital Saint Eloi
      • Nantes、フランス、44093
        • CHU Nantes - Hôtel Dieu; Service Assistance Medicale à la Procreation
      • Paris、フランス、75475
        • Hôpital Saint-Louis
      • Pierre-Benite、フランス、69495
        • Centre Hospitalier LYON SUD
      • Rennes cedex 09、フランス、35033
        • CHU Rennes - Hôpital Pontchaillou
      • Rouen、フランス、76038
        • Centre Henri Becquerel; Hematologie
      • Vandoeuvre-les-nancy、フランス、54511
        • Hôpital de Brabois Adultes

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:

General Inclusion Criteria:

  • At least one bi-dimensionally measurable lymphoma lesion on CT scan defined as > 1.5 cm in its longest dimension, which is also FDG avid by screening PET scan.
  • Confirmed availability of archival or freshly biopsied tumor tissue prior to study enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Adequate hematologic function
  • For female participants of childbearing potential, agreement to use highly effective forms of contraception

Dose-Escalation Portion of the Study:

  • Participants must have histologically confirmed B-cell NHL, except MCL or SLL
  • Participants must have never received previous R-CHOP treatment
  • Any relapsed/refractory participants that are enrolled during the dose escalation should have received only a single previous treatment regimen

Expansion Portion of the Study:

  • Participants must have previously untreated CD20-positive DLBCL and IPI score must be 2-5

Exclusion Criteria:

General Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
  • Contraindication to receive any of the individual components of CHOP, rituximab or obinutuzumab
  • Prior anthracycline therapy
  • Participants with ongoing corticosteroid use >30 mg per day of prednisone or equivalent
  • CNS lymphoma or primary mediastinal DLBCL
  • Vaccination with live vaccines within 28 days prior to randomization
  • Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
  • History of other malignancy that could affect compliance with the protocol or interpretation of results
  • Evidence of significant, uncontrolled concomitant disease
  • Significant cardiovascular disease or significant pulmonary disease
  • Left ventricular ejection fraction less than (<) 50% as defined by multiple-gated acquisition (MUGA)
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day 1
  • Received the following agents within 7 days prior to the first dose of venetoclax: steroid therapy for anti-neoplastic intent; strong and moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers; grapefruit/grapefruit products, seville oranges or star fruit within 3 days prior to the first dose of venetoclax
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Recent major surgery
  • Women who are pregnant or lactating

Dose-Escalation Portion of the Study:

  • Participants with confirmed mantle cell lymphoma (MCL) or small lymphocytic lymphoma (SLL)

Expansion Portion of the Study:

  • Participants with transformed lymphoma (participants with discordant bone marrow involvement (i.e., low grade histology in bone marrow) may be considered after discussion with the Medical Monitor)
  • Prior therapy for NHL

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：Venetoclax + G-CHOP Arm
Phase I: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle will consist of 21 days. Phase II: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle will consist of 21 days. For both phase I and II, participants with ongoing response without excessive toxicity may receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
薬：Venetoclax
Venetoclax 200 to 800 milligrams (mg) tablets will be administered orally once daily (QD) on Days 4-10 of Cycle 1 and Days 1-10 of Cycles 2-8 during Phase I and MTD will be administered according to the same schedule during Phase II.
他の名前：
  • GDC-0199、ABT-199
薬：Cyclophosphamide
Cyclophosphamide 750 milligrams per square meter (mg/m^2) administered intravenously (IV) on Day 1 of each 21-day cycle up to Cycle 6.
薬：Obinutuzumab
Obinutuzumab will be administered by IV infusion as an absolute dose of 1000 mg on Days 1, 8, 15 of Cycle 1 and Day 1 of Cycles 2-8 (cycle length = 21 days).
薬：Doxorubicin
Doxorubicin 50 mg/m^2 administered IV on Day 1 of each 21-day cycle up to Cycle 6.
薬：Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) administered IV on Day 1 of each 21-day cycle up to Cycle 6.
薬：Prednisone
Prednisone 100 mg per day orally on Days 1-5 of each 21-day cycle up to Cycle 6.
実験的：Venetoclax + R-CHOP Arm
Phase I: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle will consist of 21 days. Phase II: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle will consist of 21 days. For both phase I and II, participants with ongoing response without excessive toxicity may receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
薬：Venetoclax
Venetoclax 200 to 800 milligrams (mg) tablets will be administered orally once daily (QD) on Days 4-10 of Cycle 1 and Days 1-10 of Cycles 2-8 during Phase I and MTD will be administered according to the same schedule during Phase II.
他の名前：
  • GDC-0199、ABT-199
薬：Cyclophosphamide
Cyclophosphamide 750 milligrams per square meter (mg/m^2) administered intravenously (IV) on Day 1 of each 21-day cycle up to Cycle 6.
薬：Doxorubicin
Doxorubicin 50 mg/m^2 administered IV on Day 1 of each 21-day cycle up to Cycle 6.
薬：Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) administered IV on Day 1 of each 21-day cycle up to Cycle 6.
薬：Prednisone
Prednisone 100 mg per day orally on Days 1-5 of each 21-day cycle up to Cycle 6.
薬：Rituximab
Rituximab 375 mg/m^2 dose will be administered IV on Day 1 of every 21-day cycle.
他の名前：
  • マブセラ/リツキサン

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
Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)
時間枠：Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)
DLTs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Decrease in B cells, lymphopenia, and leukopenia caused by lymphopenia were not considered DLTs but instead were expected outcomes of study treatment. Any Grade >/= 3 adverse event, that was attributed to having a reasonable possibility of being related to the combined administration of venetoclax plus R-CHOP or G-CHOP, that could not be attributed by the investigator to an alternative, clearly identifiable cause such as tumor progression, concurrent illness or medical condition, or concomitant medication and that occurred during the DLT observation period (start of venetoclax treatment through end of Cycle 2) was considered a DLT for dose-escalation purposes. Grade 3 or 4 neutropenia or thrombocytopenia identified on Day 1 of Cycle 2 or 3, resulting in dose delay were considered DLTs.
Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)
Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC)
時間枠：Baseline up to end of treatment (up to approximately 6 months)
CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake </= mediastinum; 3) uptake < mediastinum but </= liver. No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy
Baseline up to end of treatment (up to approximately 6 months)
Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC
時間枠：Baseline up to end of treatment (up to approximately 6 months)
CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake </= mediastinum; 3) uptake < mediastinum but </= liver. No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.
Baseline up to end of treatment (up to approximately 6 months)

二次結果の測定

結果測定
メジャーの説明
時間枠
Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)
時間枠：Predose (within 30 minutes) & 2, 4, 6, 8 hours (Hr) postdose on Cycle 1 Day 4 (cycle length = 21 days)

AUC was calculated based on measurement of venetoclax concentration in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.

Data are reported as hour*micrograms per milliliter (hr*mcg/mL)
Predose (within 30 minutes) & 2, 4, 6, 8 hours (Hr) postdose on Cycle 1 Day 4 (cycle length = 21 days)
Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax)
時間枠：Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
Tmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.
Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax)
時間枠：Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)

Cmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.

Data are reported as micrograms per milliliter
Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval
時間枠：Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
Cmin was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.
Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
Prednisone Plasma PK: AUC
時間枠：Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
AUC was determined based on measurement of Predisone concentrations in plasma over time.
Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
Prednisone Plasma PK: Tmax
時間枠：Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
Tmax was determined based on measurement of Predisone concentrations in plasma over time.
Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
Prednisone Plasma PK: Cmax
時間枠：Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
Cmax was determined based on measurement of Predisone concentrations in plasma over time.
Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
Rituximab PK: Cmax
時間枠：End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Cmax was determined using the post-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Rituximab PK: Cmin Within the Dosing Interval
時間枠：Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)
Cmin was determined using the pre-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose on Day 1 of Cycle 2.
Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)
Obinutuzumab PK: Cmax
時間枠：End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Cmax was determined using the post-dose obinutuzumab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Cyclophosphamide PK: Cmax
時間枠：End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Cmax was determined using the post-dose Cyclophosphamide plasma concentrations on Cycle 1 Day 1.
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Doxorubicin PK: Cmax
時間枠：End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Cmax was determined using the post-dose Doxorubicin plasma concentrations.
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Vincristine PK: Cmax
時間枠：End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Cmax was determined using the post-dose Vincristine plasma concentrations.
End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Using the Modified Lugano Classification Assessed by IRC
時間枠：Baseline to end of treatment (up to approximately 6 months)

Objective Response defined as PR (partial response) or CR (complete response) at end of treatment.

CR: Lymph nodes and extra-lymphatic sites with score 1, 2 or 3 on a 5-point scale (with a higher score being a worse outcome). No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.

PR: Lymph nodes and extralymphatic sites with score of 4 or 5 on the 5-point scale with reduced uptake compared with baseline and residual mass(es) of any size. CT-based response criteria for PR must also be met. No new lesions. In bone marrow residual uptake could be higher than in normal marrow but must be reduced compared with baseline; persistent focal changes in the marrow to be considered for further evaluation with magnetic resonance imaging (MRI) or biopsy or an interval scan. OR=PR+CR
Baseline to end of treatment (up to approximately 6 months)
Percentage of Participants Who Are Alive and Without Disease Progression at Month 12
時間枠：Month 12
Progressive disease (PD) was determined using the modified Lugano classification criteria. For PET-CT-based PD: Score 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with an increase in intensity of uptake from baseline in target nodes and nodal lesions, new FDG-uptake foci of extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment, no non-measured lesions, new FDG-uptake foci consistent with lymphoma, new or recurrent FDG-uptake foci in bone marrow. For CT-based PD: >/= 50% decrease in SPD of up to 6 target measureable nodes and extranodal sites; non-measured lesion should be absent/normal, have regressed, but not increased; no new lesions.
Month 12
Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification
時間枠：Baseline up to end of treatment (approx. 6 months)
CR was defined as follows according to modified Lugano classification for CT-based response: Target nodes/nodal masses must have regressed to </= 1.5 cm in longest transverse diameter of a lesion (LDi), no extra-lymphatic sites of disease, absence of non-measured lesions, organ enlargement must have regressed to normal, no new lesions, and if the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.
Baseline up to end of treatment (approx. 6 months)
Safety: Percentage of Participants With Adverse Events
時間枠：Baseline up to approximately 36 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Baseline up to approximately 36 months
Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy
時間枠：Baseline up to Cycle 6 (cycle length = 21 days)
Maintenance of relative dose intensity was defined as a dose intensity of >/= 90%.
Baseline up to Cycle 6 (cycle length = 21 days)
Relative Dose Intensity of Venetoclax
時間枠：Baseline up to Cycle 6 (cycle length = 21 days)
Dose intensity was categorized as < 80%, 80% to < 85%, 85% to < 90%, or >/= 90%.
Baseline up to Cycle 6 (cycle length = 21 days)

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

Hoffmann-La Roche

協力者

AbbVie

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)

2013年11月17日

一次修了 (実際)

2017年6月28日

研究の完了 (実際)

2019年6月28日

試験登録日

最初に提出

2014年2月4日

QC基準を満たした最初の提出物

2014年2月4日

最初の投稿 (見積もり)

2014年2月5日

学習記録の更新

投稿された最後の更新 (実際)

2020年6月11日

QC基準を満たした最後の更新が送信されました

2020年5月26日

最終確認日

2020年5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

  • GO27878
  • 2013-003749-40 (EudraCT番号)

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

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。

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