Delving into the Latest Updates on Lenograstim (Genetical Recombination) with Synapse

Overview

Basic Info

Drug Type

Colony-stimulating factors

Synonyms

G-CSF (CHO cell derived), Glycosylated recombinant G-CSF, Glycosylated recombinant granulocyte colony stimulating factor

+ [14]

Target

CSF-3R

Mechanism

CSF-3R agonists(Colony stimulating factor 3 receptor agonists)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Acute Myeloid LeukemiaHead and Neck NeoplasmsTransitional Cell Carcinoma+ [3]

Inactive Indication

Hodgkin's LymphomaX-Linked Lymphoproliferative Disorder

Originator Organization

Chugai Pharmaceutical Co., Ltd.

Active Organization

Chugai Pharmaceutical Co., Ltd.

Hunan Wuhzoutong Pharmacuetical Co. Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (04 Oct 1991),

Neutropenia

Regulation-

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Structure/Sequence

Sequence Code 34410

Source: *****

To evaluate the use of G-CSF + plerixafor injection for stem cell mobilization before autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM), and the proportion of patients achieving CD34+ cells ≥ 5×106/kg within 4 days or less compared with G-CSF + placebo.

Start Date24 Nov 2016

Sponsor / Collaborator

Hunan Wuhzoutong Pharmacuetical Co. Ltd.

CTR20170560

/ RecruitingPhase 1

以粒细胞集落刺激因子（G-CSF）为基础用药普乐沙福注射液在非霍奇金淋巴瘤患者中的药代动力学与药效学研究

[Translation] Pharmacokinetics and pharmacodynamics of plerixafor injection based on granulocyte colony stimulating factor (G-CSF) in patients with non-Hodgkin's lymphoma

以G-CSF（ 5μg/kg/天[仅限格拉诺赛特Granocyte ®]）为基础用药，考察普乐沙福注射液（0.24mg/kg）在非霍奇金淋巴瘤受试者(NHL) 单次皮下给药自体移植前干细胞动员中的吸收、分布、代谢与排泄过程的药代动力学特征、药效学以及初步的安全性研究。

[Translation]

This study was conducted to investigate the pharmacokinetic characteristics, pharmacodynamics, and preliminary safety of plerixafor injection (0.24 mg/kg) in the absorption, distribution, metabolism, and excretion of a single subcutaneous dose of G-CSF (5 μg/kg/day [Granocyte ® only]) in subjects with non-Hodgkin's lymphoma (NHL) for stem cell mobilization prior to autologous transplantation.

Start Date22 Sep 2016

Sponsor / Collaborator

Hunan Wuhzoutong Pharmacuetical Co. Ltd.

100 Clinical Results associated with Lenograstim (Genetical Recombination)

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100 Translational Medicine associated with Lenograstim (Genetical Recombination)

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100 Patents (Medical) associated with Lenograstim (Genetical Recombination)

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731

Literatures (Medical) associated with Lenograstim (Genetical Recombination)

01 Dec 2024·Journal of International Medical Research

Predicting apheresis yield and factors affecting peripheral blood stem cell harvesting using a machine learning model

Article

Author: Huang, Chen ; Qi, Jing ; Wang, Nana ; Huang, Dongping ; Jin, Xiaoke ; Xie, Faqin ; Chen, Yinchu ; Wang, Ran ; Wei, Yuanfeng ; Yan, Jiawei ; Yu, Zhengzhi ; Huang, Jun

Objective Mobilization and collection of peripheral blood stem cells (PBSCs) are time-intensive and costly. Excessive apheresis sessions can cause physical discomfort for donors and increase the costs associated with collection. Therefore, it is essential to identify key predictive factors for successful harvests to minimize the need for multiple apheresis procedures. Methods We retrospectively analyzed 88 PBSC donations at our hospital. Mobilization involved disease-specific chemotherapy plus human recombinant granulocyte-colony-stimulating factor (G-CSF; lenograstim) or G-CSF alone for 5 days, followed by apheresis on day 5. The baseline characteristics of donors, pre-apheresis complete blood counts, and CD34+ cells were evaluated. Univariate logistic regression, the eXtreme Gradient Boosting algorithm, and multivariate logistic regression were applied to select significant predictive variables. The multivariate logistic regression results were integrated into various machine learning models to assess predictive accuracy. Results The percentage of pre-collection monocytes (Mono%), age, and CD34+ cell percentage (CD34+ cell%) were identified as significant independent factors that could accurately predict the success of an initial PBSC harvest. Conclusions We used machine learning methods to identify and validate Mono%, age, and CD34+ cell% as significant factors predictive of successful PBSC harvest on the first attempt, offering important insight to guide the clinical harvesting of PBSCs.

01 Aug 2024·Therapeutic Apheresis and Dialysis

A global assessment of hemostatic function of healthy allogeneic stem cell donors undergoing apheresis by rotational thromboelastometry

Article

Author: Akay, Olga Meltem ; Eren, Ozgur Can ; Cilek, Neslihan ; Yalcin, Ozlem ; Ugurel, Elif

AbstractIntroductionPeripheral blood stem cell (PBSC) collection via apheresis requires the administration of granulocyte colony‐stimulating factor (filgrastim) to stem cell donors. Several reports have shown that filgrastim administration and apheresis procedure induce a hypercoagulable state across PBSC collection, which might predispose certain donors to thrombotic complications.MethodsWe evaluated the hemostatic functions of healthy allogeneic stem cell donors by rotational thromboelastometry (ROTEM). Blood samples from healthy donors (n = 30) were collected at defined time points: before filgrastim (baseline), on the day of apheresis before and after the procedure, and 1 week after apheresis.ResultsThe results indicated that hemostatic changes are temporary since all parameters in both EXTEM and INTEM assays are restored to their initial values 1 week after the apheresis.ConclusionWe concluded that stem cell apheresis does not induce a hypercoagulable state in healthy donors. This is the first study evaluating the hemostatic functions of stem cell donors by ROTEM.

01 May 2024·Journal of the American Animal Hospital Association

Filgrastim Use in the Treatment of Azathioprine-Induced Myelosuppression Toxicity After Prescription Error in the Feline

Article

Author: Klar, Leigh

ABSTRACTOnly one report on the successful use of filgrastim (granulocyte colony-stimulating factor) in cats for severe neutropenia following azathioprine toxicity exists. Here, we report on a case in which a cat was prescribed methimazole but the medication was filled incorrectly with azathioprine tablets and the prescription label indicated a methimazole dosing regimen that was administered for three days before recognition of the error. On presentation, the cat’s physical examinations were consistent with previous examinations before ingestion of azathioprine. A complete blood cell count revealed neutropenia and leukopenia. The cat later developed hyporexia, dehydration, and vomiting. Treatment included antinausea and appetite stimulant medications, filgrastim, and antibiotics. Filgrastim given as subcutaneous injections over the course of treatment increased neutrophil cell counts after suppression. The cat made a full recovery after responding to the treatment protocol. Based on the perceived response to filgrastim in this single feline case report, its use can be considered for the treatment of azathioprine-induced neutropenia in cats.

100 Deals associated with Lenograstim (Genetical Recombination)

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External Link

KEGG	Wiki	ATC	Drug Bank
D03247	Lenograstim (Genetical Recombination)	L03AA10	DB13144

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Myeloid Leukemia	JP	Chugai Pharmaceutical Co., Ltd.	09 Dec 1997
Head and Neck Neoplasms	JP	Chugai Pharmaceutical Co., Ltd.	09 Dec 1997
Transitional Cell Carcinoma	JP	Chugai Pharmaceutical Co., Ltd.	09 Dec 1997
Acute Lymphoblastic Leukemia	JP	Chugai Pharmaceutical Co., Ltd.	30 Nov 1993
Neutropenia	JP	Chugai Pharmaceutical Co., Ltd.	04 Oct 1991

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P568 (EBMT2022)	Not Applicable	Residual Neoplasm	98	Lenograstim	(tdtisjkzaq) = 1.0% exltjiwoud (saflgcsgvs ) View more	Positive	19 Mar 2022
ASCO_GU2020	Not Applicable	Castration-Resistant Prostatic Cancer	377	Primary GCSF	iiagfbxjyo(igtysqaqrn) = evbqowhweu lfnmmhgrnn (ftypuziotr )	Positive	19 Feb 2020
				No Primary GCSF	iiagfbxjyo(igtysqaqrn) = nwdazgyizw lfnmmhgrnn (ftypuziotr )
ESMO2019	Not Applicable	Neoadjuvant \| Adjuvant	47	FLOT chemotherapy without GCSF prophylaxis	(wlugvdkvui) = zxwhskizlk nlnidecddr (nmjquszaqq ) View more	-	29 Sep 2019
P833 (EBMT2018)	Not Applicable	Bone Marrow Neoplasms \| Lymphoma	248	Lenograstim	jjfyoxapdp(mhgubtremn) = rjqbcffxbl wiiludyrxt (jjcjxvfrua ) View more	Positive	19 Nov 2018
				Filgrastim	jjfyoxapdp(mhgubtremn) = dwkerqsfvd wiiludyrxt (jjcjxvfrua ) View more
P847 (EBMT2018)	Not Applicable	Lymphoma	40	Lenograstim 5 mcg/Kg	(wucxcsrqnk) = qnjshmzjsp ogaztcnjok (tdngpfpkfs )	-	19 Nov 2018
				Biosimilar Filgrastim 10 mcg/Kg	(wucxcsrqnk) = pfhjhryinb ogaztcnjok (tdngpfpkfs )
P-284 NESC (ESMO_GI2016)	Phase 2	stomach adenocarcinoma	33	Docetaxel-Cisplatin-5FU + lenograstim	jbgcjuspkq(rklztrwqts) = occcmgumkm qmvausvcfe (emngzoxgvq )	-	29 Jun 2016
EHA2015	Not Applicable	Hematopoietic stem cell transplantation	201	Lenograstim	jzsbytmxya(sticwluuad) = tjuhtzcgqc hijmjwdmft (qpmkcwhpsk )	-	21 May 2015
EHA2015	Not Applicable	-	29	Biosimilar filgrastim (Leucostim®)	bldtrgvaqd(bmfrftrqfi) = gypzgqvwnw dpzflfhzwj (uqgwsjkesb ) View more	-	21 May 2015
				Lenograstim (Granocyte®)	bldtrgvaqd(bmfrftrqfi) = fkbymkfrvd dpzflfhzwj (uqgwsjkesb ) View more
ASCO_GI2015	Phase 2	Febrile Neutropenia	5	FOLFIRINOX with prophylactic GCSF	hhjsmiioct(kkrtmbrygz) = ertxhsxiai rhnasabgiw (vprdbuiyjo ) View more	-	20 Jan 2015
ASCO2014	Not Applicable	Breast Cancer Adjuvant	55	Pegfilgrastim	dyhhherinh(axwdqdzywh) = apmyicijsf yenbvphqjm (klwvmlhmxo ) View more	-	20 May 2014
				Lenograstim	dyhhherinh(axwdqdzywh) = gbjfwqxiyy yenbvphqjm (klwvmlhmxo ) View more