Promising lymphoma combo trial pulled before it began
NCT ID NCT04285268
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial was designed to test a combination of rituximab, venetoclax, and bortezomib in patients with diffuse large B-cell lymphoma that had come back or stopped responding to treatment. The goal was to see how many patients would have their tumors shrink or disappear. However, the study was withdrawn before any participants were enrolled, so no data were collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rituximab, venetoclax, and bortezomib
- What this could lead to
- If this combination worked, it could offer a new treatment option for patients whose lymphoma has returned or not responded to standard therapy.
- What could go wrong
- The trial was withdrawn before enrolling any participants, so no results are available. The combination may have side effects like low blood counts or infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
-
May 2020
An estimate. Start dates often move.
- Expected to finish
-
Sep 2024
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Relapsed/refractory DLBCL defined as any of the following: * Confirmed DLBCL/Burkitt lymphoma (BL)/B-cell lymphoma, unclassifiable (BCLU) by World Health Organization (WHO) 2016 classification * Double hit lymphoma (DHL) phenotype as confirmed by FISH (fluorescent in-situ hybridization) or IHC (immunohistochemistry) * Relapsed or progression of disease after at least one prior line of standard rituximab-cyclophosphamide-hydroxydaunorubicin-oncovin-prednisone (R-CHOP), rituximab-etoposide-prednisone-oncovin-cyclophosphamide-hydroxydaunorubicin (R-EPOCH) or other R-CHOP-like therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * No prior treatment with a proteasome inhibitor or prior BCL2 inhibitor * No cytotoxic chemotherapy within 2 weeks prior to study treatment * Patients who are not candidates for salvage stem cell transplant or patients who are not candidates for CAR-T (chimeric antigen receptor T-cell) therapy, patients who have progressed or relapsed after a salvage transplant or CAR-T therapy are eligible * Patients must give informed consent * Prior radiation therapy allowed to \< 25% of the bone marrow and patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Patients treated with standard postoperative adjuvant radiation therapy for other cancers are allowed. Prior radiotherapy must be completed 14 days before study entry. Lesions that have been radiated in the advanced setting cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy * Patients with lower blood counts due to marrow involvement by DHL will be eligible for the study * Absolute neutrophil count (ANC) \>= 1,000/uL * Platelets \>= 50,000/uL * Total bilirubin within normal institutional limits * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \< 3 X institutional upper limit of normal (ULN) * Creatinine \< 1.5 the upper limit of normal Exclusion Criteria: * Patients who have had prior proteasome inhibitor therapy or prior therapy with venetoclax * Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator * Patients with history of hepatitis B with negative viral load are eligible (including latent carriers and patient with history of active disease who required treatment) * History of allergic reactions attributed to compounds of similar chemical or biologic composition to venetoclax and bortezomib or other agents used in the study * Subjects with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) which is not well controlled on antiviral therapy * Patients who have received autologous hematopoietic stem cell transplantation within 12 months * Subject has received the following within 7 days prior to the first dose of study drug: Steroid therapy for anti-neoplastic intent, strong and moderate CYP3A inhibitors and/or strong and moderate CYP3A inducers * The effects of combination venetoclax and bortezomib may cause fetal harm. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 12 weeks after. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
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