A Phase Ⅲ, Randomized, Double-Blinded Study Evaluating the Safety and Efficacy of Combination Treatment of Motixafortide and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma

This is a randomized, double-blinded, placebo-controlled, multi-center phase Ⅲ bridging clinical study designed to evaluate the efficacy, safety, and pharmacokinetic and pharmacodynamic profiles of Motixafortide (BL-8040) + G-CSF vs placebo + G-CSF mobilized hematopoietic stem cells for autologous transplantation in Chinese patients with multiple myeloma.

开始日期2024-09-30

申办/合作机构

广州誉衡生物科技有限公司

100 项与 G-CSF(Guangzhou Gloria Biosciences) 相关的临床结果

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100 项与 G-CSF(Guangzhou Gloria Biosciences) 相关的转化医学

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100 项与 G-CSF(Guangzhou Gloria Biosciences) 相关的专利（医药）

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项与 G-CSF(Guangzhou Gloria Biosciences) 相关的文献（医药）

2022-10-01·Clinical Lymphoma Myeloma & Leukemia

AML-119 The Impact of Post-Remission Granulocyte Colony-Stimulating Factor (G-CSF) Use (G-CSFu) in the Phase 3 Studies of Venetoclax (Ven) Combination Treatments in Patients (Pts) With Newly Diagnosed Acute Myeloid Leukemia (AML)

Article

作者: Vorobyev, Vladimir ; Illés, Àrpád ; Wei, Xudong ; Schmidt, Xenia ; Zhang, Meng ; Kim, Inho ; Panayiotidis, Panayiotis ; Tatsch, Fernando ; Recher, Christian ; Pratz, Keith ; Miller, Catherine ; DiNardo, Courtney ; Ku, Grace ; Ivanov, Vladimir ; Potluri, Jalaja

CONTEXT:

In VIALE-A (NCT02993523) and VIALE-C (NCT03069352), Ven+azacitidine (Aza) and low-dose cytarabine (LDAC), respectively, improved outcomes in pts with intensive chemotherapy (IC)-ineligble newly diagnosed AML.

OBJECTIVE:

To explore outcomes in pts with G-CSFu.

DESIGN:

VIALE-A/C, dosing and treatment schedule were previously described. G-CSFu was given per institutional practice. Pts who achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) were analyzed by G-CSFu.

RESULTS:

In VIALE-A/C, baseline demographics were similar in Ven-treated pts regardless of G-CSFu. In VIALE-A, 190/286 pts (66%) treated with Ven+Aza and 41/145(28%) pts treated with placebo (PBO)+Aza achieved CR/CRi; 93(49%) and 10(24%) pts with CR/CRi received G-CSF (median time to first G-CSFu[range], 36d[2-483] and 35d[4-127]), respectively. Median duration of response (mDOR) for CR/CRi (95% CI) was not reached (NR; 17.5-NR) and 12.9mo(7.9-17.3) in the Ven+Aza+G-CSF and Ven+Aza+non-G-CSF groups, respectively; DOR at 12mo was 67% and 53%. Among 164 evaluable pts, measurable residual disease response (MRD<10-3) was achieved by 67, of whom 38(57%) had G-CSFu. Median overall survival (mOS[95% CI) was NR(NR-NR) with Ven+Aza+G-CSF and was 21.1mo(15.2-NR) with Ven+Aza+non-G-CSF; 12-mo OS rates were 83% and 71%. Post-remission Gr ≥3 neutropenia and febrile neutropenia (FN) rates were 33%(n=31) and 39%(n=36) with Ven+Aza+G-CSF, and 29%(n=28) and 20%(n=19) with Ven+Aza+non-G-CSF, respectively. Median durations of post-remission Gr ≥3 neutropenia and FN were 12.5d and 8d (Ven+Aza+G-CSF), and 16d and 10.5d (Ven+Aza+non-G-CSF). In VIALE-C, 69/143 pts (48%) treated with Ven+LDAC and 9/68(13%) pts treated with PBO+LDAC achieved CR/CRi; 30(43%) and 2(22%) received G-CSF (median time to first G-CSFu[range], 30d[2-459] and 229d[169-289]), respectively. mDOR was 10.8(4.9-17.8) and 11.8mo(5.9-NR) in the Ven+LDAC+G-CSF and Ven+LDAC+non-G-CSF groups, respectively; DOR at 12mo was 45% and 49%. mOS was 20.8mo(11.9-NR) with Ven+LDAC+G-CSF and 13.7mo(10.8-NR) with Ven+LDAC+non-G-CSF; 12-mo OS were ~68% and ~57%; 9/64 evaluable pts achieved MRD<10-3, of whom 6(67%) had G-CSFu. Post-remission Gr ≥3 neutropenia and FN rates were 53%(n=16) and 23%(n=7) with Ven+LDAC+G-CSF, and 51%(n=20) and 8%(n=3) with Ven+LDAC+non-G-CSF, respectively. Median durations of post-remission Gr≥3 neutropenia and FN were 15d and 6d(Ven+LDAC+G-CSF), and 12.5d and 29d(Ven+LDAC+non-G-CSF).

CONCLUSIONS:

Gr ≥3 neutropenia and FN with G-CSFu trended towards shorter duration, without negative impact on DOR or OS.

2018-11-01·Journal of child and adolescent psychopharmacology3区 · 医学

Group Cognitive Behavioral Therapy and Attention Bias Modification for Childhood Anxiety Disorders: A Factorial Randomized Trial of Efficacy

3区 · 医学

Article

作者: DeSousa, Diogo ; Castro, Stela ; Petersen, Circe S. ; Barrett, Paula ; Borba, Lidiane Nunes ; Pine, Daniel S. ; Bar-Haim, Yair ; Toazza, Rudineia ; Gallegos, Julia ; Jarros, Rafaela B. ; Abend, Rany ; Salum, Giovanni A. ; Manfro, Gisele G. ; Koller, Silvia H.

BACKGROUND:

The objective of this study is to assess group differences in symptom reduction between individuals receiving group cognitive behavioral therapy (G-CBT) and attention bias modification (ABM) compared to their respective control interventions, control therapy (CT), and attention control training (ACT), in a 2 × 2 factorial design.

METHODS:

A total of 310 treatment-naive children (7-11 years of age) were assessed for eligibility and 79 children with generalized, separation or social anxiety disorder were randomized and received G-CBT (n = 42) or CT (n = 37). Within each psychotherapy group, participants were again randomized to ABM (n = 38) or ACT (n = 41) in a 2 × 2 factorial design resulting in four groups: G-CBT + ABM (n = 21), G-CBT + ACT (n = 21), CT + ABM (n = 17), and CT + ACT (n = 20). Primary outcomes were responder designation as defined by Clinical Global Impression-Improvement (CGI-I) scale (≤2) and change on the Pediatric Anxiety Rating Scale (PARS).

RESULTS:

There were significant improvements of symptoms in all groups. No differences in response rates or mean differences in PARS scores were found among groups: G-CBT + ABM group (23.8% response; 3.9 points, 95% confidence interval [CI] -0.3 to 8.1), G-CBT + ACT (42.9% response; 5.6 points, 95% CI 2.2-9.0), CT + ABM (47.1% response; 4.8 points 95% CI 1.08-8.57), and CT + ACT (30% response; 0.8 points, 95% CI -3.0 to 4.7). No evidence or synergic or antagonistic effects were found, but the combination of G-CBT and ABM was found to increase dropout rate.

CONCLUSIONS:

We found no effect of G-CBT or ABM beyond the effects of comparison groups. Results reveal no benefit from combining G-CBT and ABM for anxiety disorders in children and suggest potential deleterious effects of the combination on treatment acceptability.

2014-06-01·Applied Health Economics and Health Policy

Biosimilar granulocyte colony-stimulating factor uptakes in the EU-5 markets: a descriptive analysis.

Article

作者: Bocquet, François ; Cordonnier, Anne-Laure ; Sinègre, Martine ; Fusier, Isabelle ; Le Pen, Claude ; Paubel, Pascal

BACKGROUND:

Biosimilars are copies of biological reference medicines. Unlike generics (copies of chemical molecules), biologics are complex, expensive and complicated to produce. The knowledge of the factors affecting the competition following patent expiry for biologics remains limited.

OBJECTIVES:

The aims of this study were to analyse the EU-5 Granulocyte-Colony Stimulating Factor (G-CSF) markets and to determine the factors affecting the G-CSF biosimilar uptakes, particularly that of biosimilar prices relative to originators.

METHODS:

Data on medicine volumes, values, and ex-manufacturer prices for all G-CSF categories were provided by IMS Health. Volumes were calculated in defined daily doses (DDD) and prices in Euros per DDD. In the EU-5 countries, there is 5 years of experience with biosimilar G-CSFs (2007-2011).

RESULTS:

Two G-CSF market profiles exist: (1) countries with a high retail market distribution, which are the largest G-CSF markets with low global G-CSF biosimilar uptakes (5.4% in France and 8.5% in Germany in 2011); and (2) countries with a dominant hospital channel, which are the smallest markets with higher G-CSF biosimilar uptakes (12.4% in Spain and 20.4% in the UK). The more the decisions are decentralized, the more their uptakes are high. The price difference between G-CSF biosimilars and their reference plays a marginal role at a global level (price differences of +13.3% in the UK and -20.4% in France).

CONCLUSION:

The competition with G-CSF biosimilars varies significantly between EU-5 countries, probably because of G-CSF distribution channel differences. Currently, this competition is not mainly based on prices, but on local political options to stimulate tendering between them and recently branded second- or third-generation products.

100 项与 G-CSF(Guangzhou Gloria Biosciences) 相关的药物交易

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