Response-Adapted, Time-Limited Venetoclax, Umbralisib & Ublituximab for Relapsed/Refractory Chronic Lymphocytic Leukemia
Time limited, response-adapted venetoclax, umbralisib and ublituximab is safe and yields high rates of undetectable MRD for relapsed CLL. Many patients with chronic lymphocytic leukemia (CLL) will develop treatment resistance to Bruton’s tyrosine kinase (BTK) inhibitors. Phosphatidylinositol-3-kinas...
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| Veröffentlicht in: | Blood advances 2024-01, Vol.8 (2), p.378-387 |
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| creator | Hill, Brian T. Ma, Shuo Zent, Clive S. Baran, Andrea M. Wallace, Danielle S. Advani, Anjali Winter, Allison Winter, Jane Gordan, Leo Karmali, Reem Liesveld, Jane L. Mulford, Deborah A. Rowland, Chris Bui, Andrew Sportelli, Peter Miskin, Hari P. Weiss, Michael S. Friedberg, Jonathan W. Barr, Paul M. |
| description | Time limited, response-adapted venetoclax, umbralisib and ublituximab is safe and yields high rates of undetectable MRD for relapsed CLL.
Many patients with chronic lymphocytic leukemia (CLL) will develop treatment resistance to Bruton’s tyrosine kinase (BTK) inhibitors. Phosphatidylinositol-3-kinase (PI3K) inhibitors, including umbralisib, have significant clinical activity in relapsed/refractory CLL, but prolonged exposure is associated with potential toxicities. Due to the synergistic anti-tumor effects of combined PI3K and BCL-2 inhibition, we sought to explore the feasibility of response-adapted, time-limited therapy to optimize disease control while mitigating the risks of prolonged treatment. We conducted a phase 1/2 clinical trial to determine the safety and efficacy of venetoclax in combination with umbralisib and the anti-CD20 monoclonal antibody, ublituximab, (U2-VeN) in patients with relapsed/refractory CLL (N=46) and Richter’s transformation (RT, N =5). After 12 cycles, treatment was stopped for patients with CLL who achieved undetectable minimal residual disease (uMRD). Adverse events of special interest included diarrhea in 50% of patients (11% grade 3/4), and AST and/or ALT elevation in 15 patients (33%), with 3 (7%) grade 3/4. There were no cases of tumor lysis syndrome (TLS) related to venetoclax, with outpatient initiation in 96% of patients. The intent-to-treat overall response rate for CLL was 98% with 100% of evaluable patients responding with 38% complete responses. The end of treatment rate of uMRD at 10-4 in bone marrow was 77% (30 out of 39), including a 71% uMRD rate among 14 patients refractory to prior BTK inhibitor. Time-limited venetoclax and U2 is safe and highly effective combination therapy for relapsed/refractory CLL patient including those who have been previously treated with covalent BTK inhibitors. This trial was registered on ClinicalTrials.gov under identifier: NCT03379051 |
| doi_str_mv | 10.1182/bloodadvances.2023010693 |
| format | Article |
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Many patients with chronic lymphocytic leukemia (CLL) will develop treatment resistance to Bruton’s tyrosine kinase (BTK) inhibitors. Phosphatidylinositol-3-kinase (PI3K) inhibitors, including umbralisib, have significant clinical activity in relapsed/refractory CLL, but prolonged exposure is associated with potential toxicities. Due to the synergistic anti-tumor effects of combined PI3K and BCL-2 inhibition, we sought to explore the feasibility of response-adapted, time-limited therapy to optimize disease control while mitigating the risks of prolonged treatment. We conducted a phase 1/2 clinical trial to determine the safety and efficacy of venetoclax in combination with umbralisib and the anti-CD20 monoclonal antibody, ublituximab, (U2-VeN) in patients with relapsed/refractory CLL (N=46) and Richter’s transformation (RT, N =5). After 12 cycles, treatment was stopped for patients with CLL who achieved undetectable minimal residual disease (uMRD). Adverse events of special interest included diarrhea in 50% of patients (11% grade 3/4), and AST and/or ALT elevation in 15 patients (33%), with 3 (7%) grade 3/4. There were no cases of tumor lysis syndrome (TLS) related to venetoclax, with outpatient initiation in 96% of patients. The intent-to-treat overall response rate for CLL was 98% with 100% of evaluable patients responding with 38% complete responses. The end of treatment rate of uMRD at 10-4 in bone marrow was 77% (30 out of 39), including a 71% uMRD rate among 14 patients refractory to prior BTK inhibitor. Time-limited venetoclax and U2 is safe and highly effective combination therapy for relapsed/refractory CLL patient including those who have been previously treated with covalent BTK inhibitors. This trial was registered on ClinicalTrials.gov under identifier: NCT03379051</description><identifier>ISSN: 2473-9529</identifier><identifier>ISSN: 2473-9537</identifier><identifier>EISSN: 2473-9537</identifier><identifier>DOI: 10.1182/bloodadvances.2023010693</identifier><identifier>PMID: 37871300</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Antibodies, Monoclonal - therapeutic use ; Bridged Bicyclo Compounds, Heterocyclic ; Heterocyclic Compounds, 4 or More Rings ; Humans ; Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy ; Leukemia, Lymphocytic, Chronic, B-Cell - pathology ; Lymphoma, B-Cell - drug therapy ; Phosphatidylinositol 3-Kinases - therapeutic use ; Phosphoinositide-3 Kinase Inhibitors ; Sulfonamides</subject><ispartof>Blood advances, 2024-01, Vol.8 (2), p.378-387</ispartof><rights>2023 The American Society of Hematology</rights><rights>2024 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c369t-e567a378fe02cf99a42f38a03e6e77bce33b5d609658f2a5aa67b9add6ba63</cites><orcidid>0000-0001-6099-3313 ; 0000-0001-9371-6777 ; 0000-0003-0984-4376 ; 0000-0003-0228-4054 ; 0000-0002-9733-401X ; 0000-0003-1666-7064 ; 0000-0002-6139-5486 ; 0000-0003-0015-5902</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,860,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37871300$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hill, Brian T.</creatorcontrib><creatorcontrib>Ma, Shuo</creatorcontrib><creatorcontrib>Zent, Clive S.</creatorcontrib><creatorcontrib>Baran, Andrea M.</creatorcontrib><creatorcontrib>Wallace, Danielle S.</creatorcontrib><creatorcontrib>Advani, Anjali</creatorcontrib><creatorcontrib>Winter, Allison</creatorcontrib><creatorcontrib>Winter, Jane</creatorcontrib><creatorcontrib>Gordan, Leo</creatorcontrib><creatorcontrib>Karmali, Reem</creatorcontrib><creatorcontrib>Liesveld, Jane L.</creatorcontrib><creatorcontrib>Mulford, Deborah A.</creatorcontrib><creatorcontrib>Rowland, Chris</creatorcontrib><creatorcontrib>Bui, Andrew</creatorcontrib><creatorcontrib>Sportelli, Peter</creatorcontrib><creatorcontrib>Miskin, Hari P.</creatorcontrib><creatorcontrib>Weiss, Michael S.</creatorcontrib><creatorcontrib>Friedberg, Jonathan W.</creatorcontrib><creatorcontrib>Barr, Paul M.</creatorcontrib><title>Response-Adapted, Time-Limited Venetoclax, Umbralisib & Ublituximab for Relapsed/Refractory Chronic Lymphocytic Leukemia</title><title>Blood advances</title><addtitle>Blood Adv</addtitle><description>Time limited, response-adapted venetoclax, umbralisib and ublituximab is safe and yields high rates of undetectable MRD for relapsed CLL.
Many patients with chronic lymphocytic leukemia (CLL) will develop treatment resistance to Bruton’s tyrosine kinase (BTK) inhibitors. Phosphatidylinositol-3-kinase (PI3K) inhibitors, including umbralisib, have significant clinical activity in relapsed/refractory CLL, but prolonged exposure is associated with potential toxicities. Due to the synergistic anti-tumor effects of combined PI3K and BCL-2 inhibition, we sought to explore the feasibility of response-adapted, time-limited therapy to optimize disease control while mitigating the risks of prolonged treatment. We conducted a phase 1/2 clinical trial to determine the safety and efficacy of venetoclax in combination with umbralisib and the anti-CD20 monoclonal antibody, ublituximab, (U2-VeN) in patients with relapsed/refractory CLL (N=46) and Richter’s transformation (RT, N =5). After 12 cycles, treatment was stopped for patients with CLL who achieved undetectable minimal residual disease (uMRD). Adverse events of special interest included diarrhea in 50% of patients (11% grade 3/4), and AST and/or ALT elevation in 15 patients (33%), with 3 (7%) grade 3/4. There were no cases of tumor lysis syndrome (TLS) related to venetoclax, with outpatient initiation in 96% of patients. The intent-to-treat overall response rate for CLL was 98% with 100% of evaluable patients responding with 38% complete responses. The end of treatment rate of uMRD at 10-4 in bone marrow was 77% (30 out of 39), including a 71% uMRD rate among 14 patients refractory to prior BTK inhibitor. Time-limited venetoclax and U2 is safe and highly effective combination therapy for relapsed/refractory CLL patient including those who have been previously treated with covalent BTK inhibitors. 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Ma, Shuo ; Zent, Clive S. ; Baran, Andrea M. ; Wallace, Danielle S. ; Advani, Anjali ; Winter, Allison ; Winter, Jane ; Gordan, Leo ; Karmali, Reem ; Liesveld, Jane L. ; Mulford, Deborah A. ; Rowland, Chris ; Bui, Andrew ; Sportelli, Peter ; Miskin, Hari P. ; Weiss, Michael S. ; Friedberg, Jonathan W. ; Barr, Paul M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c369t-e567a378fe02cf99a42f38a03e6e77bce33b5d609658f2a5aa67b9add6ba63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Bridged Bicyclo Compounds, Heterocyclic</topic><topic>Heterocyclic Compounds, 4 or More Rings</topic><topic>Humans</topic><topic>Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy</topic><topic>Leukemia, Lymphocytic, Chronic, B-Cell - pathology</topic><topic>Lymphoma, B-Cell - drug therapy</topic><topic>Phosphatidylinositol 3-Kinases - therapeutic use</topic><topic>Phosphoinositide-3 Kinase Inhibitors</topic><topic>Sulfonamides</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hill, Brian T.</creatorcontrib><creatorcontrib>Ma, Shuo</creatorcontrib><creatorcontrib>Zent, Clive S.</creatorcontrib><creatorcontrib>Baran, Andrea M.</creatorcontrib><creatorcontrib>Wallace, Danielle S.</creatorcontrib><creatorcontrib>Advani, Anjali</creatorcontrib><creatorcontrib>Winter, Allison</creatorcontrib><creatorcontrib>Winter, Jane</creatorcontrib><creatorcontrib>Gordan, Leo</creatorcontrib><creatorcontrib>Karmali, Reem</creatorcontrib><creatorcontrib>Liesveld, Jane L.</creatorcontrib><creatorcontrib>Mulford, Deborah A.</creatorcontrib><creatorcontrib>Rowland, Chris</creatorcontrib><creatorcontrib>Bui, Andrew</creatorcontrib><creatorcontrib>Sportelli, Peter</creatorcontrib><creatorcontrib>Miskin, Hari P.</creatorcontrib><creatorcontrib>Weiss, Michael S.</creatorcontrib><creatorcontrib>Friedberg, Jonathan W.</creatorcontrib><creatorcontrib>Barr, Paul M.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Blood advances</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hill, Brian T.</au><au>Ma, Shuo</au><au>Zent, Clive S.</au><au>Baran, Andrea M.</au><au>Wallace, Danielle S.</au><au>Advani, Anjali</au><au>Winter, Allison</au><au>Winter, Jane</au><au>Gordan, Leo</au><au>Karmali, Reem</au><au>Liesveld, Jane L.</au><au>Mulford, Deborah A.</au><au>Rowland, Chris</au><au>Bui, Andrew</au><au>Sportelli, Peter</au><au>Miskin, Hari P.</au><au>Weiss, Michael S.</au><au>Friedberg, Jonathan W.</au><au>Barr, Paul M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Response-Adapted, Time-Limited Venetoclax, Umbralisib & Ublituximab for Relapsed/Refractory Chronic Lymphocytic Leukemia</atitle><jtitle>Blood advances</jtitle><addtitle>Blood Adv</addtitle><date>2024-01-23</date><risdate>2024</risdate><volume>8</volume><issue>2</issue><spage>378</spage><epage>387</epage><pages>378-387</pages><issn>2473-9529</issn><issn>2473-9537</issn><eissn>2473-9537</eissn><abstract>Time limited, response-adapted venetoclax, umbralisib and ublituximab is safe and yields high rates of undetectable MRD for relapsed CLL.
Many patients with chronic lymphocytic leukemia (CLL) will develop treatment resistance to Bruton’s tyrosine kinase (BTK) inhibitors. Phosphatidylinositol-3-kinase (PI3K) inhibitors, including umbralisib, have significant clinical activity in relapsed/refractory CLL, but prolonged exposure is associated with potential toxicities. Due to the synergistic anti-tumor effects of combined PI3K and BCL-2 inhibition, we sought to explore the feasibility of response-adapted, time-limited therapy to optimize disease control while mitigating the risks of prolonged treatment. We conducted a phase 1/2 clinical trial to determine the safety and efficacy of venetoclax in combination with umbralisib and the anti-CD20 monoclonal antibody, ublituximab, (U2-VeN) in patients with relapsed/refractory CLL (N=46) and Richter’s transformation (RT, N =5). After 12 cycles, treatment was stopped for patients with CLL who achieved undetectable minimal residual disease (uMRD). Adverse events of special interest included diarrhea in 50% of patients (11% grade 3/4), and AST and/or ALT elevation in 15 patients (33%), with 3 (7%) grade 3/4. There were no cases of tumor lysis syndrome (TLS) related to venetoclax, with outpatient initiation in 96% of patients. The intent-to-treat overall response rate for CLL was 98% with 100% of evaluable patients responding with 38% complete responses. The end of treatment rate of uMRD at 10-4 in bone marrow was 77% (30 out of 39), including a 71% uMRD rate among 14 patients refractory to prior BTK inhibitor. Time-limited venetoclax and U2 is safe and highly effective combination therapy for relapsed/refractory CLL patient including those who have been previously treated with covalent BTK inhibitors. This trial was registered on ClinicalTrials.gov under identifier: NCT03379051</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>37871300</pmid><doi>10.1182/bloodadvances.2023010693</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-6099-3313</orcidid><orcidid>https://orcid.org/0000-0001-9371-6777</orcidid><orcidid>https://orcid.org/0000-0003-0984-4376</orcidid><orcidid>https://orcid.org/0000-0003-0228-4054</orcidid><orcidid>https://orcid.org/0000-0002-9733-401X</orcidid><orcidid>https://orcid.org/0000-0003-1666-7064</orcidid><orcidid>https://orcid.org/0000-0002-6139-5486</orcidid><orcidid>https://orcid.org/0000-0003-0015-5902</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Antibodies, Monoclonal - therapeutic use Bridged Bicyclo Compounds, Heterocyclic Heterocyclic Compounds, 4 or More Rings Humans Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy Leukemia, Lymphocytic, Chronic, B-Cell - pathology Lymphoma, B-Cell - drug therapy Phosphatidylinositol 3-Kinases - therapeutic use Phosphoinositide-3 Kinase Inhibitors Sulfonamides |
| title | Response-Adapted, Time-Limited Venetoclax, Umbralisib & Ublituximab for Relapsed/Refractory Chronic Lymphocytic Leukemia |
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