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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

2020년 5월 26일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

267

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 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.
다른 이름들:
  • GDC-0199, ABT-199
의약품: 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.
의약품: 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).
의약품: Doxorubicin
Doxorubicin 50 mg/m^2 administered IV on Day 1 of each 21-day cycle up to Cycle 6.
의약품: Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) administered IV on Day 1 of each 21-day cycle up to Cycle 6.
의약품: Prednisone
Prednisone 100 mg per day orally on Days 1-5 of each 21-day cycle up to Cycle 6.
실험적: 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.
의약품: 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.
다른 이름들:
  • GDC-0199, ABT-199
의약품: 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.
의약품: Doxorubicin
Doxorubicin 50 mg/m^2 administered IV on Day 1 of each 21-day cycle up to Cycle 6.
의약품: Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) administered IV on Day 1 of each 21-day cycle up to Cycle 6.
의약품: Prednisone
Prednisone 100 mg per day orally on Days 1-5 of each 21-day cycle up to Cycle 6.
의약품: Rituximab
Rituximab 375 mg/m^2 dose will be administered IV on Day 1 of every 21-day cycle.
다른 이름들:
  • 맙테라/리툭산

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)
기간: 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)
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hoffmann-La Roche

협력자

AbbVie

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2013년 11월 17일

기본 완료 (실제)

2017년 6월 28일

연구 완료 (실제)

2019년 6월 28일

연구 등록 날짜

최초 제출

2014년 2월 4일

QC 기준을 충족하는 최초 제출

2014년 2월 4일

처음 게시됨 (추정)

2014년 2월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 6월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 5월 26일

마지막으로 확인됨

2020년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

림프종, 비호지킨에 대한 임상 시험

Venetoclax에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Iran

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다