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.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
267
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Quebec、加拿大、G1J 1Z4
- CHU de Quebec - Hôpital de l' Enfant Jésus
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Alberta
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Edmonton、Alberta、加拿大、T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Kelowna、British Columbia、加拿大、V1Y 5L3
- BC Cancer Agency, CSI
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Vancouver、British Columbia、加拿大、V5Z 4E6
- BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency
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Quebec
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Montréal、Quebec、加拿大、H3T 1E2
- Jewish General Hospital; Research Unit
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Budapest、匈牙利、1122
- Országos Onkológiai Intézet
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Budapest、匈牙利、1083
- Semmelweis Egyetem
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Debrecen、匈牙利、4032
- Debreceni Egyetem; Belgyogyaszati Klinika Hematologiai Tanszek
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Salzburg、奥地利、5020
- Lkh - Universitatsklinikum Der Pmu Salzburg
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Wien、奥地利、1090
- Medizinische Universität Wien
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Campania
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Napoli、Campania、意大利、80131
- Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
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Liguria
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Genova、Liguria、意大利、16132
- Azienda Ospedaliero Universitaria San Martino
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Piemonte
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Torino、Piemonte、意大利、10126
- Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
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Sicilia
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Palermo、Sicilia、意大利、90127
- Azienda Ospedaliera Vincenzo Cervello
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Toscana
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Pisa、Toscana、意大利、56100
- Azienda Ospedaliero Universitaria Pisana; U.O. Farmaceutica
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Brno、捷克语、613 00
- Fakultni nemocnice Brno
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Hradec Kralove、捷克语、500 05
- Fakultni nemocnice Hradec Kralove
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Ostrava - Poruba、捷克语、708 52
- Fakultni Nemocnice Ostrava
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Praha 2、捷克语、128 08
- Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
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Creteil、法国、94010
- Hopital Henri Mondor, Unite Hemopathies lymphoides
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La Roche sur Yon、法国、85025
- Centre Hospitalier Departemental Les Oudairies
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Le Mans、法国、72015
- Clinique Victor Hugo; Pharmacie
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Lille、法国、59037
- Hopital Claude Huriez - CHU Lille
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Montpellier、法国、34295
- Hopital Saint Eloi
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Nantes、法国、44093
- CHU Nantes - Hôtel Dieu; Service Assistance Medicale à la Procreation
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Paris、法国、75475
- Hôpital Saint-Louis
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Pierre-Benite、法国、69495
- Centre Hospitalier LYON SUD
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Rennes cedex 09、法国、35033
- CHU Rennes - Hôpital Pontchaillou
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Rouen、法国、76038
- Centre Henri Becquerel; Hematologie
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Vandoeuvre-les-nancy、法国、54511
- Hôpital de Brabois Adultes
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New South Wales
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Concord、New South Wales、澳大利亚、2139
- Concord Repatriation General Hospital
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Queensland
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Woolloongabba、Queensland、澳大利亚、4102
- Princess Alexandra Hospital
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Victoria
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Melbourne、Victoria、澳大利亚、3000
- Peter MacCallum Cancer Centre-East Melbourne
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Parkville、Victoria、澳大利亚、3050
- Royal Melbourne Hospital
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California
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Fullerton、California、美国、92835
- St. Jude Heritage Healthcare
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Los Angeles、California、美国、90095
- UCLA Jonsson Comprehensive Cancer Center
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Santa Maria、California、美国、93454
- Central Coast Medical Oncology
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Missouri
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Saint Louis、Missouri、美国、63129
- The West Clinici
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New Jersey
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Hackensack、New Jersey、美国、07601
- Hackensack University Medical Center; WFAN - Imus Pediatric Center
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New Mexico
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Farmington、New Mexico、美国、87401
- San Juan Oncology Associates
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New York
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New York、New York、美国、10065
- Memorial Sloan-Kettering Cancer Center
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Rochester、New York、美国、14642
- Uni of Rochester Medical Center; Wilmot Cancer Center, Pharmacy Department
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Tennessee
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Nashville、Tennessee、美国、37203
- Tennessee Oncology
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Amsterdam、荷兰、1081 HV
- Amsterdam UMC location VUMC
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Rotterdam、荷兰、3015 GD
- Erasmus Medisch Centrum
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Utrecht、荷兰、3508 GA
- UMC Utrecht
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Barcelona、西班牙、08003
- Hospital Del Mar
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Barcelona、西班牙、08035
- Hospital Universitari Vall d'Hebron
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Barcelona、西班牙、08907
- ICO l´Hospitalet - Hospital Duran i Reynals; Hematology
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Madrid、西班牙、28034
- Hospital Universitario Ramon y Cajal
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Madrid、西班牙、280146
- Hospital Universitario La Paz
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Salamanca、西班牙、37007
- Hospital Universitario De Salamanca
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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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.
其他名称：
Cyclophosphamide 750 milligrams per square meter (mg/m^2) administered intravenously (IV) on Day 1 of each 21-day cycle up to Cycle 6.
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).
Doxorubicin 50 mg/m^2 administered IV on Day 1 of each 21-day cycle up to Cycle 6.
Vincristine 1.4 mg/m^2 (maximum 2 mg) administered IV on Day 1 of each 21-day cycle up to Cycle 6.
Prednisone 100 mg per day orally on Days 1-5 of each 21-day cycle up to Cycle 6.
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实验性的：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.
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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.
其他名称：
Cyclophosphamide 750 milligrams per square meter (mg/m^2) administered intravenously (IV) on Day 1 of each 21-day cycle up to Cycle 6.
Doxorubicin 50 mg/m^2 administered IV on Day 1 of each 21-day cycle up to Cycle 6.
Vincristine 1.4 mg/m^2 (maximum 2 mg) administered IV on Day 1 of each 21-day cycle up to Cycle 6.
Prednisone 100 mg per day orally on Days 1-5 of each 21-day cycle up to Cycle 6.
Rituximab 375 mg/m^2 dose will be administered IV on Day 1 of every 21-day cycle.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)
大体时间：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)
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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.
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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)
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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)
大体时间：Baseline up to end of treatment (up to approximately 6 months)
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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
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Baseline up to end of treatment (up to approximately 6 months)
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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
大体时间：Baseline up to end of treatment (up to approximately 6 months)
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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.
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Baseline up to end of treatment (up to approximately 6 months)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)
大体时间：Predose (within 30 minutes) & 2, 4, 6, 8 hours (Hr) postdose on Cycle 1 Day 4 (cycle length = 21 days)
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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)
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Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax)
大体时间：Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
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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.
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Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
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Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax)
大体时间：Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
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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)
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Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval
大体时间：Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
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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.
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Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
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Prednisone Plasma PK: AUC
大体时间：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)
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AUC was determined based on measurement of Predisone concentrations in plasma over time.
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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)
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Prednisone Plasma PK: Tmax
大体时间：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)
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Tmax was determined based on measurement of Predisone concentrations in plasma over time.
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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)
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Prednisone Plasma PK: Cmax
大体时间：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)
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Cmax was determined based on measurement of Predisone concentrations in plasma over time.
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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)
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Rituximab PK: Cmax
大体时间：End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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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.
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End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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Rituximab PK: Cmin Within the Dosing Interval
大体时间：Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)
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Cmin was determined using the pre-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose on Day 1 of Cycle 2.
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Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)
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Obinutuzumab PK: Cmax
大体时间：End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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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.
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End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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Cyclophosphamide PK: Cmax
大体时间：End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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Cmax was determined using the post-dose Cyclophosphamide plasma concentrations on Cycle 1 Day 1.
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End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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Doxorubicin PK: Cmax
大体时间：End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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Cmax was determined using the post-dose Doxorubicin plasma concentrations.
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End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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Vincristine PK: Cmax
大体时间：End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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Cmax was determined using the post-dose Vincristine plasma concentrations.
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End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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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
大体时间：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)
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Percentage of Participants Who Are Alive and Without Disease Progression at Month 12
大体时间：Month 12
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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.
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Month 12
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Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification
大体时间：Baseline up to end of treatment (approx. 6 months)
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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.
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Baseline up to end of treatment (approx. 6 months)
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Safety: Percentage of Participants With Adverse Events
大体时间：Baseline up to approximately 36 months
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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.
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Baseline up to approximately 36 months
|
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Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy
大体时间：Baseline up to Cycle 6 (cycle length = 21 days)
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Maintenance of relative dose intensity was defined as a dose intensity of >/= 90%.
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Baseline up to Cycle 6 (cycle length = 21 days)
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Relative Dose Intensity of Venetoclax
大体时间：Baseline up to Cycle 6 (cycle length = 21 days)
|
Dose intensity was categorized as < 80%, 80% to < 85%, 85% to < 90%, or >/= 90%.
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Baseline up to Cycle 6 (cycle length = 21 days)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Zelenetz AD, Salles G, Mason KD, Casulo C, Le Gouill S, Sehn LH, Tilly H, Cartron G, Chamuleau MED, Goy A, Tam CS, Lugtenburg PJ, Petrich AM, Sinha A, Samineni D, Herter S, Ingalla E, Szafer-Glusman E, Klein C, Sampath D, Kornacker M, Mobasher M, Morschhauser F. Venetoclax plus R- or G-CHOP in non-Hodgkin lymphoma: results from the CAVALLI phase 1b trial. Blood. 2019 May 2;133(18):1964-1976. doi: 10.1182/blood-2018-11-880526. Epub 2019 Mar 8.
- Samineni D, Huang W, Gibiansky L, Ding H, Zhang R, Li C, Sinha A, Rajwanshi R, Humphrey K, Bazeos A, Salem AH, Miles D. Population Pharmacokinetics and Exposure-Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma. Adv Ther. 2022 Jan;39(1):598-618. doi: 10.1007/s12325-021-01919-z. Epub 2021 Nov 25.
- Morschhauser F, Feugier P, Flinn IW, Gasiorowski R, Greil R, Illes A, Johnson NA, Larouche JF, Lugtenburg PJ, Patti C, Salles GA, Trneny M, de Vos S, Mir F, Samineni D, Kim SY, Jiang Y, Punnoose E, Sinha A, Clark E, Spielewoy N, Humphrey K, Bazeos A, Zelenetz AD. A phase 2 study of venetoclax plus R-CHOP as first-line treatment for patients with diffuse large B-cell lymphoma. Blood. 2021 Feb 4;137(5):600-609. doi: 10.1182/blood.2020006578. Erratum In: Blood. 2021 Apr 1;137(13):1844.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年11月17日
初级完成 (实际的)
2017年6月28日
研究完成 (实际的)
2019年6月28日
研究注册日期
首次提交
2014年2月4日
首先提交符合 QC 标准的
2014年2月4日
首次发布 (估计)
2014年2月5日
研究记录更新
最后更新发布 (实际的)
2020年6月11日
上次提交的符合 QC 标准的更新
2020年5月26日
最后验证
2020年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GO27878
- 2013-003749-40 (EudraCT编号)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.