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1024 Bortezomib and Rituximab in Newly Diagnosed Adolescent and Adult CD20-Positive Philadelphia (Ph) Negative Precursor B-Cell Acute Lymphoblastic Leukemia: A Phase II Study

Program: Oral and Poster Abstracts
Session: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Poster I
Hematology Disease Topics & Pathways:
Leukemia, ALL, Diseases, Lymphoid Malignancies
Saturday, December 5, 2020, 7:00 AM-3:30 PM

Vasu Babu Goli, MD1*, Hasmukh Jain, MD, DM1,2*, Prashant Tembhare, MD3,4*, Dhanlaxmi Lalit Shetty, PhD5,6*, Avinash Bonda, MD, DM1,2*, Lingaraj Nayak, MD, DM2,7*, Nikhil Patkar, MD4,8*, Papagudi Ganesan Subramanian, MD4,9* and Manju Sengar, MD, DM1,10

1Department of Medical Oncology, Tata Memorial Centre, Mumbai, India
2Adult Hematolymphoid Disease Management Group, Tata Memorial Centre, Mumbai, India
3Adult & Pediatric Hematolymphoid Disease Management Group, Department of Medical Oncology, Tata Memorial Centre, Mumbai, India
4Hematopathology Laboratory, Tata Memorial Centre, Mumbai, India
5Adult Hematolymphoid Disease Management Group, Department of Medical Oncology, ACTREC, Navi Mumbai, Maharashtra, IND
6Adult Hematolymphoid Disease Management Group, Department of Medical Oncology, Tata Memorial Centre, Mumbai, India
7Bone Marrow Transplant Unit, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre., Navi Mumbai., India
8Haematopathology Laboratory, Tata Memorial Hospital, Navi Mumbai, India
9Hematopathology Laboratory, ACTREC, Tata Memorial Centre, Mumbai, Maharashtra, India
10Adult Hematolymphoid Disease Management Group, Tata Memorial Centre, Mumbai, Maharashtra, India

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% (<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.

Disclosures: No relevant conflicts of interest to declare.

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