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）

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

BACKGROUNDThe 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.METHODSA 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).RESULTSThere 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.CONCLUSIONSWe 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.

2012-03-01·Targeted Oncology3区 · 医学

Presently available biosimilars in hematology-oncology: G-CSF

3区 · 医学

Review

作者: Gascon, Pere

Biopharmaceuticals were copies of endogenous human proteins developed in the mid-1990s that were characterized by complex three-dimensional, high-molecular weight compounds. What made them unique was that contrary to classical chemotherapeutical drugs, they were manufactured by living cells. One of these biopharmaceuticals was granulocyte-colony stimulating factor (G-CSF). Once their patent expired, generic versions appeared in pharmacies. They are now called biosimilars. There are several biosimilar G-CSFs approved in Europe: Biograstim®/Filgrastim ratiopharm/Ratiograstim®/Tevagrastim® (XM02); Zarzio® and Nivestim®. All these new products are manufactured in facilities with state-of-the-art technology. All products have passed the regulatory requirements for approval, mainly phase I and phase III, with the consequent PD/PK evaluations and studies on efficacy and safety. However, there are still some concerns regarding their long-term evaluation, in particular, the limited experience at the time of approval of these products in terms of efficacy, safety and immunogenicity. For this reason, pharmacovigilance should be rigorous. A lot of work remains to be done in terms of clarification with regard to substituting a biosimilar G-CSF for the innovator product and, finally, information must be provided to physicians, pharmacists and patients to allow for proper decision-making. Ultimately, only clinical trials and effective post-marketing pharmacovigilance will provide definitive evidence that a biosimilar is comparable to the originator-reference product in terms of efficacy and safety.

Psychotherapy2区 · 心理学

Interpersonal learning is associated with improved self-esteem in group psychotherapy for women with binge eating disorder.

2区 · 心理学

Article

作者: Balfour, Louise ; Ritchie, Kerri ; Bissada, Hany ; Tasca, Giorgio A ; Gallagher, Meagan E ; Maxwell, Hilary

Yalom and Leszcz (2005) indicated that interpersonal learning is a key therapeutic factor in group psychotherapy. In this study, we conceptualized interpersonal learning as the convergence over time between an individual's and the group's perception of the individual's cohesion to the group. First, we developed parallel measures of: (a) an individual's self-rated cohesion to the group (Cohesion Questionnaire-Individual Version [CQ-I]), and (b) the group's rating of the individual's cohesion to the group (CQ-G) based on the original Cohesion Questionnaire (CQ; Piper, Marache, Lacroix, Richardsen, & Jones, 1983). Second, we used these parallel scales to assess differences between an individual's self-rating and the mean of the group's ratings of the individual's cohesion to the group. Women with binge eating disorder (N = 102) received Group Psychodynamic Interpersonal Psychotherapy. Participants were assigned to homogeneously composed groups of either high or low attachment anxiety. Outcomes were measured pre- and post-treatment, and the CQ-I and CQ-G were administered every fourth group session. We found significant convergence over time between the CQ-I and mean CQ-G scale scores in both attachment anxiety conditions. Participants with higher attachment anxiety had lower individual self-ratings of cohesion and had greater discrepancies between the CQ-I and CG-G compared with those with lower attachment anxiety. There was a significant relationship between greater convergence in cohesion ratings and improved self-esteem at post-treatment. More accurate self-perceptions through feedback from group members may be a key factor in facilitating increased self-esteem in group therapy. Group therapists may facilitate such interpersonal learning, especially for those higher in attachment anxiety, by noting discrepancies and then encouraging convergence between an individual and the group in their perceptions of cohesion to the group.

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

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