A Phase 2 interventional study of Bortezomib and Rituximab in High Grade B-Cell Lymphoma, Not Otherwise Specified, Recurrent Burkitt Lymphoma and Recurrent Diffuse Large B-Cell Lymphoma, sponsored by Rutgers, The State University of New Jersey. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Rutgers, The State University of New Jersey · Phase 2, Interventional, and Treatment
This phase II trial studies how well rituximab, venetoclax, and bortezomib work in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Venetoclax and bortezomib may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. Giving rituximab, venetoclax, and bortezomib may slow or stop the growth of cancer cells in patients with diffuse large B-cell lymphoma.
PRIMARY OBJECTIVE:
I. To determine the overall response rate (ORR) of rituximab, venetoclax, and bortezomib in relapsed/refractory diffuse large B-cell lymphoma.
SECONDARY OBJECTIVES:
I. To describe the safety profile of rituximab, venetoclax, and bortezomib in diffuse large B-cell lymphoma (DLBCL).
II. To describe the progression free survival of subjects enrolled to the study.
III. To describe the median overall survival of subjects enrolled to the study. IV. To describe the complete remission (CR) rate, the partial remission (PR) rate and the duration of response (DoR) of rituximab, venetoclax, and bortezomib in relapsed/refractory DLBCL.
EXPLORATORY OBJECTIVE:
I. To describe the association of BCL2 expression status, measured by immunohistochemistry (IHC), with ORR, CR and PR rates.
OUTLINE:
Patients receive rituximab intravenously (IV) on day -1 of cycle 1, then on day 1 of cycles 2-6. Patients also receive venetoclax orally (PO) once daily (QD) on days 1-14 and bortezomib IV or subcutaneously (SC) on day -1 of cycle 1, then on days 1, 8, and 15 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles for rituximab and up to 26 cycles for venetoclax and bortezomib in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.
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Relapsed/refractory DLBCL defined as any of the following:
Exclusion Criteria:
Patients receive rituximab IV on day -1 of cycle 1, then on day 1 of cycles 2-6. Patients also receive venetoclax PO QD on days 1-14 and bortezomib IV or SC on day -1 of cycle 1, then on days 1, 8, and 15 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles for rituximab and up to 26 cycles for venetoclax and bortezomib in the absence of disease progression or unacceptable toxicity.
Drug: Bortezomib · Biological: Rituximab · Drug: Venetoclax
Given IV or SC
Also known as: [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341, PS341, Velcade
Given IV
Also known as: ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab ABBS, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, rituximab biosimilar TQB2303, rituximab-abbs, RTXM83, Truxima
Given PO
Also known as: ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto
Overall response rate (ORR)
Defined as the proportion of subjects who achieve a best response of a partial response (PR) or better. The ORR (complete and partial responses) will be reported as a percentage with a 95% confidence interval. If response is missing for any patients, those patients will still be included in the denominator when reporting the response rate.
Time frame: Up to 4 years
Incidence of adverse events
Toxicity parameters will be defined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (V) 5.0. Descriptive statistics will be provided for the safety data.
Time frame: Up to 30 days post treatment
Progression free survival (PFS)
The Kaplan-Meier curve will be used to estimate the corresponding PFS distribution and median PFS for patients treated on this study.
Time frame: From study enrollment to disease progression or death from any cause, assessed up to 4 years
Overall survival (OS)
The Kaplan-Meier curve will also be used to estimate the corresponding OS distribution and median OS for all treated patients. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date").
Time frame: From study enrollment to the date of death from any cause, assessed up to 4 years
Complete response (CR) and partial response (PR) rates
Defined as the proportion of subjects who achieve a best response of CR or PR respectively.
Time frame: Up to 4 years
Duration of response (DoR)
The Kaplan-Meier curve will be used to estimate the corresponding DoR distribution and median DoR for patients treated on this study who achieve a CR or PR.
Time frame: From when measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 4 years
BCL2 protein expression
BCL2 protein expression by immunohistochemistry will be defined as positive or negative based on the most recent available biopsy report of each patient's diffuse large B-cell lymphoma. Descriptive statistics will be provided for the exploratory analysis of BCL2 expression and response to treatment.
Time frame: Up to 4 years
This study is withdrawn, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Rutgers, The State University of New Jersey