A Phase II, Randomised Study of CHOP-R in Combination With Acalabrutinib Compared to CHOP-R in Patients With Newly Diagnosed Richter's Syndrome and a Platform for Initial Investigations Into Activity of Novel Treatments in Relapsed/Refractory and Newly Diagnosed Richter's Syndrome.

The STELLAR trial will assess the effect of acalabrutinib taken in combination with CHOP-R compared to taking CHOP-R alone in patients with newly diagnosed Richter's Syndrome (RS). It will also be a platform to test other new drugs that show potential for treating RS. Chronic lymphocytic Leukaemia (CLL) is the most common blood cancer in adults, usually in their 70s or older. In a few patients, CLL can transform from a slow-growing cancer into an aggressive lymphoma called Richter's Syndrome. RS is very difficult to treat and patients have a short life-expectancy - usually a few months after diagnosis. Treatment for Richter's Syndrome in the UK is CHOP (four chemotherapy drugs) plus rituximab ('R' - an antibody treatment). The CHOP-R treatment is given as a standard of care for RS but has limited benefit - it is often temporary to extend life. Richter's Syndrome returns in most patients who then die from this disease. The STELLAR trial will investigate if a new drug called acalabrutinib, which is effective used by itself in patients with relapsed CLL and also some with Richter's Syndrome, will improve outcomes for newly diagnosed patients with RS. Acalabrutinib blocks a protein in CLL which can stop the cancer growing.
Participants who have Richter's Syndrome and are suitable for CHOP-R will be recruited by specialised hospitals across the UK. People with another cancer, heart problems, or recent stroke cannot take part. Participants will have a lymph node biopsy, 3-4 bone marrow biopsies, blood samples, and PET-CT and CT scans. CHOP-R is given in a hospital every three weeks up to 6 times. All participants will receive CHOP-R; half will also receive acalabrutinib. When treatment with CHOP-R ends the patients who had acalabrutinib can continue to take it; patients who had CHOP-R alone may have acalabrutinib if their Richter's Syndrome returns after CHOP-R.

开始日期2019-07-23

申办/合作机构

University of Birmingham

[+2]

NCT02933320 / Completed临床1/2期IIT

A Cancer Research UK Phase I/IIa Clinical Trial of BI-1206; an Antibody to FcƔRIIB (CD32b), as a Single Agent and in Combination With an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Malignancy

The purpose of this trial is to identify the tolerable dose of BI-1206 (both alone and in combination) for patients with B-cell lymphoma and leukaemia and further evaluate BI-1206 alone and in combination with an anti-CD20 antibody.

开始日期2016-10-27

申办/合作机构

Cancer Research UK

[+2]

NCT02752204 / Completed临床2期IIT

Torch: A Phase II Study to Determine the Safety and Efficacy of the Dual mTORC Inhibitor AZD2014 and to Investigate Additional Toxicities in Combination With Rituximab in Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)

The aim of this clinical trial is to see if the drug called AZD2014 is effective and safe to use to treat patients with relapsed or refractory Diffuse Large BCell Lymphoma (DLBCL). The trial will also be looking at combining the antibody (Rituximab) with the drug AZD2014 in a small number of patients to see if this can be done without increasing the toxicity. 36 patients will be recruited to the trial. 30 will receive AZD2014 alone and the remaining 6 will receive AZD2014 plus rituximab. AZD2014 will be given as a 125mg tablet that is to be taken twice a day for 2 days out of every 7 (i.e. on days 1 and 2 of every week). Rituximab will be given via IV infusion on day 1 of every 28 days (once every 4 weeks) for a maximum of 6 cycles.

开始日期2015-10-01

申办/合作机构

University of Birmingham

[+3]

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项与 Bloodwise 相关的文献（医药）

2011-11-18·Blood

Impact of Age on Physician's Decision to Pursue Active Treatment in Elderly Patients with Myelodysplastic Syndromes: Results from an Internet-Based Survey

作者: Huber, John ; Waldman, Anita ; Kurtin, Sandra E. ; Campbell, Kenneth ; Smith, B. Douglas ; Santini, Valeria

AbstractAbstract 5045PURPOSE:Myelodysplastic syndromes (MDS) are a group of hematological disorders predominantly affecting older patients. A patient's age influences the treating physician's decision to proceed with active treatment in MDS, with older patients being less likely than younger patients to receive active treatment, irrespective of their physical status.DESIGN:This study is an internet-based survey of hematologists and oncologists who treat patients with MDS consisting of a 47-item questionnaire designed to assess 1) factors physicians consider when determining treatment recommendations for MDS patients, 2) the impact of patient age on treatment decisions and 3) views on tools available to physicians to guide their treatment plans. Respondents were given hypothetical patient scenarios and asked to select their recommended treatment based on the available information.RESULTS:A total of 310 online interviews were conducted in North America and Europe. Although physicians cited biological age and disease performance status as more important, chronological age nevertheless emerged as a strong influencing factor on their treatment recommendations for MDS patients aged 65 years and older. For instance, physicians were significantly more likely to prescribe active therapy to a 70-year-old patient with secondary MDS and an intermediate International Prognostic Scoring System level than to an 80-year-old patient with otherwise identical characteristics (32% vs. 12%; p<0.05). Concerns regarding treatment toxicity influenced the recommendations of 66% of physicians, and 29% expressed dissatisfaction with the amount of data available to help guide treatment recommendations. A majority (62%) agreed that better guidelines would prevent under-treatment of older patients.CONCLUSION:Chronological age can influence physicians' treatment recommendations for MDS patients. The findings suggest that some older patients may be denied appropriate treatment options due to age and support the need for additional clinical evidence for older patients with MDS, such as validated comprehensive geriatric assessment tools to support treatment decisions regarding active treatment.Disclosures:Smith: Celgene: Honoraria. Santini:Celgene: Honoraria. Kurtin:Celgene: Honoraria. Huber:Celgene: Honoraria. Campbell:Celgene: Honoraria. Waldman:Celgene: Honoraria.

项与 Bloodwise 相关的新闻（医药）

2022-06-15

·PRNewswire

Global Orphan Diseases Partnering Deals Report 2022: Access to Headline, Upfront, Milestone and Royalty Data

DUBLIN, June 15, 2022 /PRNewswire/ -- The "Global Orphan Diseases Partnering 2010-2022: Deal Trends, Players and Financials" report has been added to ResearchAndMarkets.com's offering. The Global Orphan Diseases Partnering 2010-2022 report provides comprehensive access to available deals and contract documents for over 280 orphan diseases deals signed between the world's pharmaceutical and biotechnology companies since 2010. Trends in Orphan Diseases partnering deals Financial deal terms for headline, upfront and royalty by stage of development Orphan Diseases partnering agreement structure Orphan Diseases partnering contract documents Top Orphan Diseases deals by value Most active Orphan Diseases dealmakers Most of the deals included within the report occur when a licensee obtains a right or an option right to license a licensor's product or technology. More often these days these deals tend to be multi-component including both a collaborative R&D and a commercialization of outcomes element. The report takes readers through the comprehensive Orphan Diseases disease deal trends, key players and top deal values allowing the understanding of how, why and under what terms companies are currently entering Orphan Diseases deals. The report presents financial deal terms values for Orphan Diseases deals, where available listing by overall headline values, upfront payments, milestones and royalties enabling readers to analyse and benchmark the value of current deals. The initial chapters of this report provide an orientation of Orphan Diseases dealmaking trends. Chapter 2 provides an overview of the trends in Orphan Diseases dealmaking since 2010 covering trends by year, deal type, stage of development, technology type and therapeutic indication. Chapter 3 includes an analysis of financial deal terms covering headline value, upfront payment, milestone payments and royalty rates. Chapter 4 provides a review of the leading Orphan Diseases deals since 2010. Deals are listed by headline value. The chapter includes the top 25 most active Orphan Diseases dealmakers, together with a full listing of deals to which they are a party. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 5 provides comprehensive access to Orphan Diseases deals since 2010 where a deal contract is available, providing the user with direct access to contracts as filed with the SEC regulatory authorities. Each deal title links via Weblink to an online version of the deal record contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive directory of all Orphan Diseases partnering deals by specific Orphan Diseases target announced since 2010. The chapter is organized by specific Orphan Diseases therapeutic target. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. In addition, a comprehensive appendix is provided with each report of all Orphan Diseases partnering deals signed and announced since 2010. The appendices are organized by company A-Z, stage of development at signing, deal type (collaborative R&D, co-promotion, licensing etc) and technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. The report also includes numerous tables and figures that illustrate the trends and activities in Orphan Diseases partnering and dealmaking since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of Orphan Diseases technologies and products. Report scope Global Orphan Diseases Partnering 2010 to 2022 includes: Trends in Orphan Diseases dealmaking in the biopharma industry since 2010 Access to headline, upfront, milestone and royalty data Access to hundreds of Orphan Diseases deal contract documents Comprehensive access to over 280 Orphan Diseases deal records The leading Orphan Diseases deals by value since 2010 Most active Orphan Diseases dealmakers since 2010 In Global Orphan Diseases Partnering 2010 to 2022, available deals and contracts are listed by: Headline value Upfront payment value Royalty rate value Stage of development at signing Deal component type Technology type Specific therapy indication Analyzing actual contract agreements allows assessment of the following: What are the precise rights granted or optioned? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Key Topics Covered: Executive Summary Chapter 1 - Introduction Chapter 2 - Trends in Orphan Diseases dealmaking 2.1. Introduction 2.2. Orphan Diseases partnering over the years 2.3. Orphan Diseases partnering by deal type 2.4. Orphan Diseases partnering by industry sector 2.5. Orphan Diseases partnering by stage of development 2.6. Orphan Diseases partnering by technology type Chapter 3 -Financial deal terms for Orphan Diseases partnering 3.1. Introduction 3.2. Disclosed financials terms for Orphan Diseases partnering 3.3. Orphan Diseases partnering headline values 3.4. Orphan Diseases deal upfront payments 3.5. Orphan Diseases deal milestone payments 3.6. Orphan Diseases royalty rates Chapter 4 - Leading Orphan Diseases deals and dealmakers 4.1. Introduction 4.2. Most active in Orphan Diseases partnering 4.3. List of most active dealmakers in Orphan Diseases 4.4. Top Orphan Diseases deals by value Chapter 5 - Orphan Diseases contract document directory 5.1. Introduction 5.2. Orphan Diseases partnering deals where contract document available Chapter 6 - Orphan Diseases dealmaking by therapeutic target 6.1. Introduction 6.2. Deals by Orphan Diseases therapeutic target Appendices Appendix 1 - Directory of Orphan Diseases deals by company A-Z since 2010 Appendix 2 - Directory of Orphan Diseases deals by deal type since 2010 Appendix 3 - Directory of Orphan Diseases deals by stage of development since 2010 Appendix 4 - Directory of Orphan Diseases deals by technology type since 2010 Table of figures Figure 1: Orphan Diseases partnering since 2010 Figure 2: Orphan Diseases partnering by deal type since 2010 Figure 3: Orphan Diseases partnering by industry sector since 2010 Figure 4: Orphan Diseases partnering by stage of development since 2010 Figure 5: Orphan Diseases partnering by technology type since 2010 Figure 6: Orphan Diseases partnering by indication since 2010 Figure 7: Orphan Diseases deals with a headline value Figure 8: Orphan Diseases deals with upfront payment values Figure 9: Orphan Diseases deals with milestone payment Figure 10: Orphan Diseases deals with royalty rates Figure 11: Active Orphan Diseases dealmaking activity since 2010 Figure 12: Top Orphan Diseases deals by value since 2010 Companies Mentioned MSD Action Foundation (MSDAF) Oxford BioMedica Edmond Pharma Ligand Pharmaceuticals Florida Biologix Abbvie Castle Creek Pharmaceuticals Nestle Health Science Enable Injections BioTie Therapies European Commission G-treeBNT OncoSec Medical BioNTech Hematech DBV Technologies Videregen CSL Behring BioXcel Vericel Leukaemia & Lymphoma Research ArmaGen Abiogen Pharma Janssen Sciences Soligenix Medicenna Therapeutics Catalent Cutaneous Lymphoma Foundation Novasep OncoPep Moulder Center for Drug Discovery Research Spooner Girls Foundation Jupiter Orphan Therapeutics Marnier-Lapostolle Foundation Plexcera ProThera Kalytera Therapeutics Acceleron Pharma Regenerx Fortress Biotech Synageva BioPharma ImmuneWorks Rare Expertise For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 SOURCE Research and Markets

100 项与 Bloodwise 相关的药物交易

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100 项与 Bloodwise 相关的转化医学

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