[Translation] A prospective/retrospective non-interventional study of VIDAZA® (azacitidine) in Chinese patients with International Prognostic Scoring System (IPSS) intermediate-2 and high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia or acute myeloid leukemia with 20-30% blasts and multilineage dysplasia

本研究是一项回顾性和前瞻性、非干预性、多中心研究，将评估在常规医疗实践条件下，按照中国产品说明书接受阿扎胞苷（AZA）治疗的中危-2（Int-2）和高危骨髓增生异常综合征（MDS）（根据IPSS确定）或慢性粒单核细胞白血病（CMML）或伴20-30%骨髓（BM）原始细胞和多系发育异常的急性髓系白血病（AML）的（根据WHO分类确定）患者在真实世界环境中（包括住院和门诊环境）的安全性和有效性。

[Translation]

This retrospective and prospective, non-interventional, multicenter study will evaluate the safety and efficacy of azacitidine (AZA) in patients with intermediate-risk-2 (Int-2) and high-risk myelodysplastic syndrome (MDS) (determined by IPSS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML) with 20-30% bone marrow (BM) blasts and multilineage dysplasia (determined by WHO classification) treated with the Chinese product label under routine medical practice conditions in real-world settings (including inpatient and outpatient settings).

Start Date25 Feb 2022

Sponsor / Collaborator

Celgene Consulting (Shanghai) Co., Ltd.

[+2]

CTR20160088 / CompletedPhase 3

比较来那度胺与安慰剂分别联合R-CHOP在初治ABC型DLBCL受试者中的疗效和安全性的随机、双盲、多中心III期临床研究

[Translation] A randomized, double-blind, multicenter phase III clinical study comparing the efficacy and safety of lenalidomide and placebo combined with R-CHOP in subjects with newly diagnosed ABC-type DLBCL

比较来那度胺联合R-CHOP化疗（R2-CHOP）与安慰剂联合R-CHOP（安慰剂-R-CHOP）化疗在既往未接受治疗的活化B细胞型弥漫性大B细胞淋巴瘤（DLBCL）受试者中的疗效和安全性

[Translation]

To compare the efficacy and safety of lenalidomide plus R-CHOP chemotherapy (R2-CHOP) versus placebo plus R-CHOP chemotherapy (placebo-R-CHOP) in subjects with previously untreated activated B-cell diffuse large B-cell lymphoma (DLBCL)

Start Date07 Apr 2016

Sponsor / Collaborator

Penn Pharmaceutical Services Ltd.

[+2]

CTR20140716 / Active, not recruitingPhase 3

比较利妥昔单抗联合来那度胺与利妥昔单抗联合安慰剂治疗复发性/难治性惰性淋巴瘤的疗效和安全性的研究

[Translation] A study comparing the efficacy and safety of rituximab combined with lenalidomide and rituximab combined with placebo in the treatment of relapsed/refractory indolent lymphoma

评估利妥昔单抗联合来那度胺（CC-5013）治疗复发性/难治性惰性淋巴瘤的疗效和安全性。

[Translation]

To evaluate the efficacy and safety of rituximab combined with lenalidomide (CC-5013) in the treatment of relapsed/refractory indolent lymphoma.

Start Date05 Nov 2014

Sponsor / Collaborator

Penn Pharmaceutical Services Ltd.

[+2]

100 Clinical Results associated with Celgene Europe Ltd.

0 Patents (Medical) associated with Celgene Europe Ltd.

Literatures (Medical) associated with Celgene Europe Ltd.

20 May 2019·Journal of Clinical Oncology

Tislelizumab (BGB-A317) + concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy for newly diagnosed locally advanced, unresectable, stage III non-small cell lung cancer (NSCLC) in a phase III study (RATIONALE 001).

Author: Senan, Suresh ; Paz-Ares, Luis G. ; Planchard, David ; Nguyen, Marie Huong ; Vokes, Everett E. ; Cheong, Alicia ; Slepetis, Ruta ; Wang, Luhua

TPS8574 Background: cCRT improves survival vs RT alone and is a global standard of care in patients (pts) with stage III NSCLC, but survival remains poor for these pts. Combining PD-1/PD-L1-targeting immunotherapies and cCRT may lead to synergistic activity and improved outcomes. Tislelizumab (anti–PD-1) demonstrated clinical activity and tolerability in solid tumors, including NSCLC. This phase III, randomized, double-blind, placebo-controlled study (RATIONALE 001) will evaluate efficacy and safety of tislelizumab + cCRT. Methods: Pts (N ≈ 840) will be randomized 1:1:1 in a 3-arm study design to evaluate whether the timing of giving tislelizumab earlier upfront with cCRT in addition to as consolidation (Arm 1) or giving tislelizumab as consolidation only (Arm 2) will improve outcomes vs cCRT alone (Arm 3; Table). RT will be given in 2 Gy fractions to a target dose of 60 Gy (30 fractions). Chemotherapy will be investigator’s choice of cisplatin + etoposide or carboplatin + paclitaxel. A safety analysis specific to the cisplatin + etoposide component of the cCRT + tislelizumab combination is planned. All sites must pass a radiation quality assurance review process. The primary endpoint is PFS. Secondary endpoints include ORR, OS, OS at 24 months, and safety. As an exploratory endpoint, blood and tumor biomarkers will be assessed for correlations with clinical benefit. With a one-sided α of 1.25%, a total of 580 PFS events are required to allow ≈ 90% power to detect a HR for progression or death of 0.7 for either pairwise comparison (Arm 1 vs Arm 3 or Arm 2 vs Arm 3). Key eligibility criteria are locally advanced, unresectable, stage III NSCLC; FDG-PET and brain imaging confirmation of stage III status; no prior treatment; and ECOG PS ≤ 1. PD-L1 expression assessment is not required prior to randomization. EudraCT number 2018-001132-22. Clinical trial information: NCT03745222. [Table: see text]

01 May 2019·Journal of NeurologyQ2 · MEDICINE

Multi-database study of multiple sclerosis: identification, validation and description of MS patients in two countries

Q2 · MEDICINE

Article

Author: Yood, Marianne Ulcickas ; Jick, Susan ; Persson, Rebecca ; Evans, Amber ; Wagner, Michael ; Minton, Neil ; Lindholm, Anders ; Lee, Sally ; Niemcryk, Steve

OBJECTIVETo describe the resources and methods used to identify and validate multiple sclerosis (MS) and match non-MS patients in each of the two databases, and to characterize their demographics, comorbidities and concomitant medications.METHODSThis study was conducted in two separate electronic medical databases, the United States Department of Defense (DOD) military health care system and the United Kingdom's Clinical Practice Research Datalink (CPRD) GOLD. We identified patients with a first recorded diagnosis of MS in 2001-2016 (CPRD) or 2004-2017 (DOD) and matched non-MS patients using algorithms appropriate to each database. We describe patient symptoms, comorbidities, and medication use at the time of the MS diagnosis and compared them to the non-MS cohort.RESULTSWe identified 8695 patients with MS and 86,934 matched non-MS patients in the DOD database and 6932 patients with MS and 68,526 matched non-MS patients in CPRD GOLD. Most MS patients were female (around 70%) and were diagnosed before age 60 (88%). MS patients had higher prevalence of depression and other psychiatric conditions at MS diagnosis compared to non-MS patients. Epilepsy, fractures and infections were also more common. MS patients had many expected symptoms and treatments documented in their records prior to the MS diagnosis.CONCLUSIONThese results are consistent between the two databases, as well as with previous studies of MS. Future analyses of these patients' experience after MS diagnosis will provide valuable insights into disease and treatment patterns in relation to risk of chronic diseases and mortality.

01 Feb 2016·Journal of Clinical Oncology

A phase I safety and pharmacokinetic (PK) study of nab-paclitaxel (nab-P) plus gemcitabine (Gem) for patients (pts) with advanced pancreatic cancer (APC) who have cholestatic hyperbilirubinemia (CH) secondary to bile duct obstruction.

Author: Ramanathan, Ramesh K. ; Riess, Hanno ; Philip, Philip Agop ; Chen, Peng ; Romano, Alfredo ; Kunzmann, Volker ; Seufferlein, Thomas ; McGovern, Desmond Micahel Thomas

TPS474 Background: In pts with APC, the distal common bile duct is frequently obstructed, which can lead to elevated bilirubin levels. Normalization of bilirubin by stenting can take weeks, so treatment options that could be initiated in pts with elevated bilirubin are desirable. In a phase III trial of pts with metastatic PC, nab-P + Gem demonstrated superior efficacy vs Gem alone for all endpoints, including overall survival (OS; median, 8.7 vs 6.6 months; hazard ratio, 0.72; P < 0.001). This study will be the first to analyze safety and PK profiles of nab-P + Gem in pts with APC and CH secondary to bile duct obstruction. Methods: Treatment-naive pts (≈ 12 to 40) with APC, Karnofsky performance status ≥ 70, and CH due to bile duct obstruction are eligible. Pts with a biliary stent must have 2 stable (within 20% of each other) bilirubin readings within 48 to 72 hours of each other taken between 5 and 21 days after stenting. Exclusion criteria consist of brain metastases, any other active malignancy, infection requiring systemic therapy, a history of myocardial infarction, or current use of medications known to be strong inducers of CYP3A4 and CYP2C8. Pts will enter 1 of 2 cohorts based on bilirubin level: cohort 1, > 1.5 to 3 × upper limit of normal (ULN), or cohort 2, > 3 to 5 × ULN. Cohort 2 will proceed only after review of safety and PK data from cohort 1 by a safety monitoring committee (SMC) and a decision has been made to proceed. The starting doses are nab-P 100 mg/m2 and Gem 800 mg/m2 for cohort 1 and nab-P 75 mg/m2 and Gem 600 mg/m2 for cohort 2. Treatment will be administered on days 1, 8, and 15 of each 28-day cycle. Doses in each cohort will be modified according to tolerability as determined by the SMC. The primary endpoints are determination of maximum tolerated dose for each cohort and PK profile. Secondary endpoints include investigator-assessed objective response rate, progression-free survival, OS, PK profile of Gem, and safety. The exploratory endpoint is change in serum CA19-9 level from baseline. Enrollment is ongoing. ClinicalTrials.gov: NCT02267707. Clinical trial information: NCT02267707.

100 Deals associated with Celgene Europe Ltd.

100 Translational Medicine associated with Celgene Europe Ltd.

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Drug(Targets)	Indications	Global Highest Phase

Lenalidomide ( CK1α x CRBN x IFNγ x IKZF1 x IKZF3 x IL-2 x IL-6 x TNF-α )	Marginal Zone B-Cell Lymphoma More	Phase 3
Lepirudin Recombinant(Celgene) ( prothrombin )	Thromboembolism More	Withdrawn
Romidepsin ( HDACs )	Non-Hodgkin Lymphoma More	Discontinued

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