Trial · NCT04739813
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma
NCT04739813, Phase 1, Active not recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma. Trials, record NCT04739813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04739813
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma
- NCT number
- NCT04739813
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 49 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Lymphoma, Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma, Burkitt Lymphoma
- Interventions
Obinutuzumab, Prednisone, Revlimid, Polatuzumab, Ibrutinib, Venetoclax, EKG, Bone marrow aspiration, Bone marrow biopsy, CT, MRI, PET, Tumor tissue/Biopsy, Acetaminophen, Diphenhydramine, Venetoclax, Polatuzumab
- First posted
- 2021-02-05
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Escalation: Number of Grade 3, 4 and/or 5 Dose-limiting (DLT) Adverse Events at Each Dose Level With Type | 21 days | Number, type and grade of adverse events at each dose level was assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. A DLT is a grade 3 or higher adverse event at least possibly related to the study agent that occurs within the first 21 days of Cycle 1 of treatment. |
| Primary | Maximum Tolerated Dose (MTD) of Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma | 21 Days (Cycle 1) | MTD is defined as the dose level at which no more than 1 of up to 6 participants experience a dose-limiting toxicity, or the dose level below that at which at least 2 (of ≤6) participants have a DLT. A DLT is a grade 3 or higher adverse event at least possibly related to the study agent that occurs within the first 21 days of Cycle 1 of treatment. Such as Grade 3 nausea with maximum medical supportive care and persisting ≤7 days; Grade 3 vomiting or diarrhea f the participant does not require total parenteral nutrition (TPN), tube feeding, or hospitalization, and the toxicity improves to \< grade 3 within ≤3 days; Grade 3 fatigue persisting ≤7 days; Grade 3 fever or infection; Grade 3 infusion related reaction; Grade 3 febrile neutropenia; Grade 3 or Grade 4 neutropenia, Grade 3 thrombocytopenia not associated with grade 2 or greater bleeding; Grade 3 anemia persisting ≤7 days; and treatment delay of Cycle 2 for ≤7 days for hematologic toxicity. |
| Primary | Maximum Tolerated Dose (MTD) of Venetoclax in Relapsed/Refractory B-cell Lymphoma | 21 Days (Cycle 1) | MTD is defined as the dose level at which no more than 1 of up to 6 participants experience a dose-limiting toxicity, or the dose level below that at which at least 2 (of ≤6) participants have a DLT. A DLT is a grade 3 or higher adverse event at least possibly related to the study agent that occurs within the first 21 days of Cycle 1 of treatment. Such as Grade 3 nausea with maximum medical supportive care and persisting ≤7 days; Grade 3 vomiting or diarrhea f the participant does not require total parenteral nutrition (TPN), tube feeding, or hospitalization, and the toxicity improves to \< grade 3 within ≤3 days; Grade 3 fatigue persisting ≤7 days; Grade 3 fever or infection; Grade 3 infusion related reaction; Grade 3 febrile neutropenia; Grade 3 or Grade 4 neutropenia, Grade 3 thrombocytopenia not associated with grade 2 or greater bleeding; Grade 3 anemia persisting ≤7 days; and treatment delay of Cycle 2 for ≤7 days for hematologic toxicity. |
| Secondary | Overall Response Rate (ORR) | Every 42 days for 3 assessments (e.g., every 2 cycles) and/or end of treatment, up to 18 weeks | Overall response rate was assessed by the Lugano Classification Response Criteria for Non-Hodgkin Lymphoma. Complete response is no extralymphatic sites of disease or new lesions, and target nodes/nodal masses must regress to ≤1.5 cm in longest diameter. of a lesion. Partial response is ≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites. Progressive disease is progressive metabolic disease. Node or lesion longest transverse diameter of a lesion (LDi) \>1.5 cm and increase by ≥50% from cross product of the LDi and perpendicular diameter (PPD) nadir and an increase in LDi or shortest axis perpendicular to the LDi (SDi) from nadir; 0.5 cm for lesions ≤2 cm and 1.0 cm for lesions \>2 cm. Also new or clear progression of pre-existing nonmeasured lesions. ORR was measured by the Kaplan Meier method and reported along with a 2-sided 95% confidence interval. |
| Secondary | Duration of Response | Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented or death | DOR is defined as the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented or death, assessed every 3-12 months, measured by the Kaplan Meier method and reported along with a 2-sided 95% confidence interval. Response was assessed by the Lugano Classification Response Criteria for Non-Hodgkin Lymphoma. Complete response is no extralymphatic sites of disease or new lesions, and target nodes/nodal masses must regress to ≤1.5 cm in longest diameter. Partial response is ≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites. Progressive disease is progressive metabolic disease. Node or lesion longest transverse diameter of a lesion (LDi) \>1.5 cm and increase by ≥50% from cross product of the LDi and perpendicular diameter (PPD) nadir. |
| Secondary | Progression-free Survival (PFS) | Time from date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first | PFS is defined as the time from date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first, assessed every 3-12 months measured by the Kaplan Meier method and reported along with a 2-sided 95% confidence interval. Response was assessed by the Lugano Classification Response Criteria for Non-Hodgkin Lymphoma. Disease relapse is Progressive disease is progressive metabolic disease. Node or lesion longest transverse diameter of a lesion (LDi) \>1.5 cm and increase by ≥50% from cross product of the LDi and perpendicular diameter (PPD) nadir. |
| Secondary | Event-free Survival (EFS) | Time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), or death, whichever occurs first | EFS is defined as the time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), or death, whichever occurs first, assessed every 3-12 months. measured by the Kaplan Meier method and reported along with a 2-sided 95% confidence interval. Response was assessed by the Lugano Classification Response Criteria for Non-Hodgkin Lymphoma. Diseae relapse is Progressive disease is progressive metabolic disease. Node or lesion longest transverse diameter of a lesion (LDi) \>1.5 cm and increase by ≥50% from cross product of the LDi and perpendicular diameter (PPD) nadir. |
| Secondary | Overall Survival (OS) | Time from the date of study enrollment until death from any cause | OS is defined as the time from the date of study enrollment until death from any cause, assessed every 3-12 months measured by the Kaplan Meier method and reported along with a 2-sided 95% confidence interval. |
| Secondary | Complete Response Rate in Non-Germinal Center B-cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL) Treated at the Maximum Tolerated Dose (MTD) | Every 42 days for 3 assessments (e.g., every 2 cycles) and/or end of treatment, up to 18 weeks | Complete response rate is based on Lugano Classification Response Criteria for Non-Hodgkin Lymphoma. Complete response is no extralymphatic sites of disease or new lesions, and target nodes/nodal masses must regress to ≤1.5 cm in longest diameter of a lesion. Progressive disease is progressive metabolic disease. Node or lesion longest transverse diameter of a lesion (LDi) \>1.5 cm and increase by ≥50% from cross product of the LDi and perpendicular diameter (PPD) nadir and an increase in LDi or shortest axis perpendicular to the LDi (SDi) from nadir; 0.5 cm for lesions ≤2 cm and 1.0 cm for lesions \>2 cm. Also new or clear progression of pre-existing nonmeasured lesions. Complete response is measured by the Kaplan Meier method and reported along with a 2-sided 95% confidence interval. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Adverse Events were monitored/assessed from the date of first dose of any study drug, through 30 days after the last dose of any study drug, an average of 5.2 months | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04739813
GET https://conductscience.org/api/trials/v1/NCT04739813/registered