Estudio primario

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Año 2023
Autores Qianfoshan Hospital
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To observe the efficacy and safety of obinutuzumab in Chinese population with idiopathic membranous nephropathy and guide clinical management.

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Estudio primario

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Año 2019
Autores Niguarda Hospital
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This study is a multicenter, open-label, uncontrolled, phase II trial aimed to establish the safety and tolerability of venetoclax, atezolizumab and obinutuzumab combination in Richter Transformation of CLL.

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Estudio primario

No clasificado

Año 2023
Autores Ng, J.Y. , Joshi, M. , Choi, P.Y.-I.
Revista Blood
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Estudio primario

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Año 2015
Revista Emerging infectious diseases

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Two cases of disseminated enteroviral infection occurred in patients who received the CD20 monoclonal antibody obinutuzumab. Clinical features included hepatitis, edema, and a dermatomyositis-like syndrome. These manifestations may be unfamiliar to clinicians and are possibly responsive to intravenous immunoglobulin. Clinicians should remain vigilant for enteroviral infections in patients receiving obinutuzumab.

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Estudio primario

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Año 2013
Autores Gilead Sciences
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The primary objective of this study is to evaluate the effects of idelalisib with obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.

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Estudio primario

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Año 2018
Registro de estudios clinicaltrials.gov

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This is phase 1/2 study for patients with CLL or (SLL) who have not been previously treated. This study will evaluate whether obinutuzumab and lenalidomide is safe and tolerable in this setting and induce complete clinical responses.

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Estudio primario

No clasificado

Año 2023
Revista Journal of clinical oncology

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Background: In an early‐phase study, the combination of zanubrutinib plus obinutuzumab (ZO) was well tolerated and associated with an early signal of efficacy in patients (pts) with follicular lymphoma (FL) (Tam et al. Blood Adv 2020). ROSEWOOD (NCT03332017) is a phase 2, randomized study designed to assess efficacy and safety of ZO vs obinutuzumab (O) in pts with relapsed/refractory (R/R) FL. Here, we present an updated analysis with a median follow‐up of 20.2 mo. Methods: Pts with R/R FL (grade 1‐3a) who received ≥2 lines of therapy including an anti‐CD20 antibody and alkylating agent were randomized 2:1 to receive ZO or O. Zanubrutinib was given at 160 mg twice daily until progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR) by independent central review. Secondary endpoints included duration of response (DOR), progression‐free survival (PFS), time to next treatment (TTNT), overall survival (OS), and safety. Results: A total of 217 pts were randomized (145 for ZO; 72 for O). Median age was 64 years. Of the 217 pts, 114 (52.5%) had a high Follicular Lymphoma International Prognostic Index (FLIPI) score at screening and 123 (56.7%) pts had high tumor burden criteria according to Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria. Median number of prior lines of therapy was 3 (range, 2‐11). A total of 114 (52.5%) pts were refractory to rituximab; 214 (98.6%) pts received prior immunochemotherapy. Prior exposure to anticancer drugs included anthracyclines (80.6%), cyclophosphamide (94.0%), and bendamustine (54.8%). ORR was 69.0% (ZO) vs 45.8%(O) (P = 0.0012). Complete response rate was 39.3% (ZO) vs 19.4% (O); 18‐mo DOR rate was 69.3% (ZO) vs 41.9% (O); median PFS was 28.0 mo (ZO) vs 10.4 mo (O) (hazard ratio [HR], 0.50 [95% CI.: 0.33, 0.75]; P = 0.0007). Median TTNT was not evaluable for ZO and 12.2 mo for O (HR, 0.34 [95% CI.: 0.22, 0.52]; P < 0.0001). Estimated OS rate at 24 mo was 77.3% (ZO) and 71.4% (O), with median OS not reached in either arm. Nonhematologic treatmentemergent adverse events of any grade that occurred more frequently for ZO vs O (>5%difference) were petechiae (6.3% vs 0%) and herpes zoster infection (6.3% vs 0%); in contrast, pyrexia (13.3% vs 19.7%) and infusion‐related reaction (2.8% vs 9.9%) occurred more frequently in pts on O. When adjusted for duration of treatment exposure, incidences of infection and cytopenia were similar, and incidence of all grades of hemorrhage was 2.4 (ZO) vs 1.3 (O) persons per 100 person‐months. Two pts in each treatment group reported major hemorrhage. Incidences of atrial fibrillation and hypertension were low and similar in both treatment arms. Conclusions: ZO demonstrated meaningful activity and a manageable safety profile in pts with heavily pretreated R/R FL, representing a potential novel therapy.

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Estudio primario

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Año 2024
Autores Beigene Ltd.
Registro de estudios Clinical Trials Information System

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Estudio primario

No clasificado

Año 2018
Revista Blood advances
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Early data on venetoclax-containing regimens for the treatment of chronic lymphocytic leukemia (CLL) show promising results with deep remissions, but are hampered by potential risk for tumor lysis syndrome (TLS). Whether optimal duration of venetoclax treatment can be guided by minimal residual disease (MRD) is currently unknown. To study whether TLS risk can be mitigated in an unfit population by introducing preinduction, and whether MRD-guided duration of venetoclax treatment is a feasible and efficacious approach, we performed the Dutch-Belgian Cooperative Trial Group for Hemato-oncology (HOVON) 139/GIVE trial. The study treatment consists of 4 treatment phases: preinduction (2 cycles obinutuzumab), induction I (6 cycles obinutuzumab and venetoclax), induction II (6 cycles venetoclax), and a randomization phase (group A: maintenance with 12 additional cycles of venetoclax irrespective of MRD; group B: MRD guided venetoclax maintenance with a maximum of 12 cycles). Here we report on a planned interim safety analysis as well as preliminary efficacy and MRD data of the first 30 patients enrolled. Downgrading of TLS risk after preinduction occurred in 25 patients: 3 from high to medium, 3 from high to low, and 19 from medium to low risk. No patient remained high risk. From these 30 patients, peripheral blood MRD data were obtained for 28 patients at the end of induction II (6 months after the last obinutuzumab dose), of whom 26 had undetectable MRD levels, and for 18 patients who reached the 3-month after-randomization point, of whom 16 had undetectable MRD levels. Obinutuzumab preinduction is tolerated well in these unfit patients and results in abrogating high TLS risk in all patients. Preliminary data indicate that efficacy is maintained with a high proportion of patients with undetectable MRD levels after combination treatment. © 2018 American Society of Hematology. All rights reserved.

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Estudio primario

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Año 2015
Autores [No se listan los autores]
Registro de estudios EU Clinical Trials Register
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INTERVENTION:

Product Name: Venetoclax (GDC‐0199) Product Code: RO553‐7382/F01‐01 Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

Venetoclax Current Sponsor code: RO5537382 Other descriptive name: GDC‐0199/ABT‐199 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Product Name: Venetoclax (GDC‐0199) Product Code: RO553‐7382/F04‐01 Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

Venetoclax Current Sponsor code: RO5537382 Other descriptive name: GDC‐0199/ABT‐199 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Product Name: Venetoclax Product Code: RO553‐7382/F05‐01 Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

Venetoclax Current Sponsor code: RO5537382 Other descriptive name: GDC‐0199/ABT‐199 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: Gazyvaro Product Name: Obinutuzumab Product Code: RO5072759/F06‐01 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed

INN:

Obinutuzumab CAS Number: 949142‐50‐1 Current Sponsor code: RO5072759 Other descriptive name: OBINUTUZUMAB, GA101 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000‐ Trade Name: Chlorambucil Product Name: Chlorambucil Product Code: RO0059978 Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

CHLORAMBUCIL CAS Number: 305‐03‐3 Current Sponsor code: RO0059978 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐

CONDITION:

chronic lymphocytic leukemia ; MedDRA version: 20.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 100000004864 Therapeutic area: Diseases [C] ‐ Cancer [C04]

PRIMARY OUTCOME:

Main Objective: To determine efficacy by investigator‐assessed PFS of a combined regimen of obinutuzumab and Venetoclax compared with GClb in previously untreated patients with CLL who have coexisting medical conditions. Primary end point(s): Progression‐free survival (PFS), defined as the time from randomization to the first occurrence of progression, relapse or death from any cause as assessed by the investigator using IWCLL criteria Secondary Objective: To determine efficacy as assessed by additional outcome measures, including PFS assessed by Independent Review Committee [IRC], overall response, complete response and Minimal residual disease (MRD) response rate as measured by allele‐specific oligonucleotide polymerase chain reaction [ASO‐PCR]; Timepoint(s) of evaluation of this end point: At baseline, day 1 of cycle 7 and 9, day 1 of cycle 4, day 28 after treatment completion or early termination, during follow up i.e. 3 months after treatment completion or early termination and then regularly until 5 years from last patient enrolled.;

SECONDARY OUTCOME:

Secondary end point(s): ‐ PFS based on Institutional Review Committee (IRC)‐assessments, defined as the time from randomization to the first occurrence of progression or relapse or death from any cause ; ‐ Objective response rate ([ORR] defined as rate of a clinical response of complete response [CR], CR with incomplete bone marrow recovery [CRi] or partial response [PR]) as determined by the investigator, according to the IWCLL criteria ; ‐Complete response rate (defined as rate of a clinical response of CR or CRi at the completion of treatment assessment, as determined by the investigator according to the IWCLL guidelines) ; ‐ Minimal residual disease (MRD) response rate, as measured by allele‐specific oligonucleotide polymerase chain reaction (ASO‐PCR) ; ‐ ORR at completion of combination treatment response assessment ; ‐ MRD response rate, as measured by ASO‐PCR at completion of combination treatment response assessment ; ‐ Overall survival ; ‐ Duration of objective response ; ‐ Best response achieved (CR, CRi, PR, stable disease, or progressive disease) ; ‐ Event‐free survival ; ‐ Time to next anti‐leukemic treatment ; ‐ Incidence of adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 ; ‐ Incidence of severe adverse events ; ‐ Incidence of adverse events of special interest Timepoint(s) of evaluation of this end point: Up to 5 years from last patient enrolled. ;

INCLUSION CRITERIA:

‐ Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria ‐ CLL requiring treatment according to IWCLL criteria ‐ Total Cumulative Illness Rating Scale (CIRS score) > 6 ‐ Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL ‐ Adequate liver function ‐ Life expectancy > 6 months ‐ Agreement to use highly effective contraceptive methods per protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 357

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