Bortezomib and Rituximab in Newly Diagnosed Adolescent and Adult CD20-Positive Philadelphia (Ph) Negative Precursor B-Cell Acute Lymphoblastic Leukemia: A Phase II Study

Bortezomib and Rituximab in Newly Diagnosed Adolescent and Adult CD20-Positive Philadelphia (Ph) Negative Precursor B-Cell Acute Lymphoblastic Leukemia: A Phase II Study

Background: The expression of CD20 in precursor B-cell ALL has been associated with poor outcomes. The addition of rituximab with intensive chemotherapy in this subset of ALL has led to improvement in the event-free survival. Further increment in outcomes require novel approaches. Bortezomib is an a...

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Veröffentlicht in:Blood 2020-11, Vol.136 (Supplement 1), p.26-26
Hauptverfasser: Goli, Vasu Babu, Jain, Hasmukh, Tembhare, Prashant, Shetty, Dhanlaxmi Lalit, Bonda, Avinash, Nayak, Lingaraj, Patkar, Nikhil, Subramanian, Papagudi Ganesan, Sengar, Manju
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container_end_page 26
container_issue Supplement 1
container_start_page 26
container_title Blood
container_volume 136
creator Goli, Vasu Babu
Jain, Hasmukh
Tembhare, Prashant
Shetty, Dhanlaxmi Lalit
Bonda, Avinash
Nayak, Lingaraj
Patkar, Nikhil
Subramanian, Papagudi Ganesan
Sengar, Manju
description Background: The expression of CD20 in precursor B-cell ALL has been associated with poor outcomes. The addition of rituximab with intensive chemotherapy in this subset of ALL has led to improvement in the event-free survival. Further increment in outcomes require novel approaches. Bortezomib is an active drug in relapsed ALL as well as has synergistic activity with rituximab in B-cell lymphomas; thus the addition of bortezomib to rituximab and chemotherapy may improve the outcomes in CD20-positive precursor B-cell ALL. Methods: We conducted a phase II study to test the activity of bortezomib and rituximab in combination with a paediatric inspired regimen during induction therapy in newly diagnosed adolescent and adults (>14 years of age) with CD20-positive, Philadelphia (Ph)-negative precursor B-ALL, with bone marrow measurable residual disease (MRD) negativity at the end of induction (EOI) as the primary endpoint. Results: From December 2017 through August 2019, a total of 35 patients were enrolled. A total of 70.99% patients achieved EOI MRD negative status. MRD negative rates improved to 88% post consolidation. There was no significant increase in toxicity with addition of bortezomib and rituximab to standard chemotherapy. The incidence of neuropathy was 26% (
doi_str_mv 10.1182/blood-2020-140801
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The addition of rituximab with intensive chemotherapy in this subset of ALL has led to improvement in the event-free survival. Further increment in outcomes require novel approaches. Bortezomib is an active drug in relapsed ALL as well as has synergistic activity with rituximab in B-cell lymphomas; thus the addition of bortezomib to rituximab and chemotherapy may improve the outcomes in CD20-positive precursor B-cell ALL. Methods: We conducted a phase II study to test the activity of bortezomib and rituximab in combination with a paediatric inspired regimen during induction therapy in newly diagnosed adolescent and adults (&gt;14 years of age) with CD20-positive, Philadelphia (Ph)-negative precursor B-ALL, with bone marrow measurable residual disease (MRD) negativity at the end of induction (EOI) as the primary endpoint. Results: From December 2017 through August 2019, a total of 35 patients were enrolled. A total of 70.99% patients achieved EOI MRD negative status. MRD negative rates improved to 88% post consolidation. There was no significant increase in toxicity with addition of bortezomib and rituximab to standard chemotherapy. The incidence of neuropathy was 26% (&lt;grade 3). After a median follow up of 18 months, event-free survival and overall survival were 81.8% and 84.7%, respectively. Conclusion: The combination of bortezomib, rituximab and paediatric-inspired ALL regimen is active and well tolerated in in de-novo CD20 positive Ph-negative precursor B-ALL. No relevant conflicts of interest to declare.</description><identifier>ISSN: 0006-4971</identifier><identifier>EISSN: 1528-0020</identifier><identifier>DOI: 10.1182/blood-2020-140801</identifier><language>eng</language><publisher>Elsevier Inc</publisher><ispartof>Blood, 2020-11, Vol.136 (Supplement 1), p.26-26</ispartof><rights>2020 American Society of Hematology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids></links><search><creatorcontrib>Goli, Vasu Babu</creatorcontrib><creatorcontrib>Jain, Hasmukh</creatorcontrib><creatorcontrib>Tembhare, Prashant</creatorcontrib><creatorcontrib>Shetty, Dhanlaxmi Lalit</creatorcontrib><creatorcontrib>Bonda, Avinash</creatorcontrib><creatorcontrib>Nayak, Lingaraj</creatorcontrib><creatorcontrib>Patkar, Nikhil</creatorcontrib><creatorcontrib>Subramanian, Papagudi Ganesan</creatorcontrib><creatorcontrib>Sengar, Manju</creatorcontrib><title>Bortezomib and Rituximab in Newly Diagnosed Adolescent and Adult CD20-Positive Philadelphia (Ph) Negative Precursor B-Cell Acute Lymphoblastic Leukemia: A Phase II Study</title><title>Blood</title><description>Background: The expression of CD20 in precursor B-cell ALL has been associated with poor outcomes. The addition of rituximab with intensive chemotherapy in this subset of ALL has led to improvement in the event-free survival. Further increment in outcomes require novel approaches. Bortezomib is an active drug in relapsed ALL as well as has synergistic activity with rituximab in B-cell lymphomas; thus the addition of bortezomib to rituximab and chemotherapy may improve the outcomes in CD20-positive precursor B-cell ALL. Methods: We conducted a phase II study to test the activity of bortezomib and rituximab in combination with a paediatric inspired regimen during induction therapy in newly diagnosed adolescent and adults (&gt;14 years of age) with CD20-positive, Philadelphia (Ph)-negative precursor B-ALL, with bone marrow measurable residual disease (MRD) negativity at the end of induction (EOI) as the primary endpoint. Results: From December 2017 through August 2019, a total of 35 patients were enrolled. A total of 70.99% patients achieved EOI MRD negative status. MRD negative rates improved to 88% post consolidation. There was no significant increase in toxicity with addition of bortezomib and rituximab to standard chemotherapy. The incidence of neuropathy was 26% (&lt;grade 3). After a median follow up of 18 months, event-free survival and overall survival were 81.8% and 84.7%, respectively. Conclusion: The combination of bortezomib, rituximab and paediatric-inspired ALL regimen is active and well tolerated in in de-novo CD20 positive Ph-negative precursor B-ALL. 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The addition of rituximab with intensive chemotherapy in this subset of ALL has led to improvement in the event-free survival. Further increment in outcomes require novel approaches. Bortezomib is an active drug in relapsed ALL as well as has synergistic activity with rituximab in B-cell lymphomas; thus the addition of bortezomib to rituximab and chemotherapy may improve the outcomes in CD20-positive precursor B-cell ALL. Methods: We conducted a phase II study to test the activity of bortezomib and rituximab in combination with a paediatric inspired regimen during induction therapy in newly diagnosed adolescent and adults (&gt;14 years of age) with CD20-positive, Philadelphia (Ph)-negative precursor B-ALL, with bone marrow measurable residual disease (MRD) negativity at the end of induction (EOI) as the primary endpoint. Results: From December 2017 through August 2019, a total of 35 patients were enrolled. A total of 70.99% patients achieved EOI MRD negative status. 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title Bortezomib and Rituximab in Newly Diagnosed Adolescent and Adult CD20-Positive Philadelphia (Ph) Negative Precursor B-Cell Acute Lymphoblastic Leukemia: A Phase II Study
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