Trial · NCT05211336
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System
NCT05211336, Phase 1, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-04-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System. Trials, record NCT05211336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05211336
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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 (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System
- NCT number
- NCT05211336
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 14 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Primary Diffuse Large B-cell Lymphoma of the Central Nervous System (CNS), Aggressive B-cell Lymphoma With Secondary Involvement of the CNS
- Interventions
Obinutuzumab, Prednisone, Lenalidomide, Venetoclax, Ibrutinib, Acetaminophen, Diphenhydramine, Peg-filgrastim, CT Scan (chest, abdomen, and pelvis), MRI, 18f-FDG-PET, PET, Lumbar puncture/Ommaya tap, Bone marrow aspiration/biopsy, EKG
- First posted
- 2022-01-27
- Last updated
- 2026-01-08
- Results first posted
- 2025-04-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Who Completed at Least 2 Cycles of VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) Therapy Without Stopping Due to Toxicity | After 2 Cycles (each cycle is 21 days) | The proportion of participants who complete at least 2 cycles of VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) therapy without stopping due to toxicity will be determined and reported along with a 95% confidence interval. Success is defined as completing at least 2 cycles of VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) therapy without the need to discontinue treatment due to toxicity (i.e., serious adverse event). 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. |
| Secondary | Complete Response (CR) | After cycles 3 and 6 | Complete response is disappearance of all detectable evidence of disease and disease-related symptoms measured by the Lugano criteria. The complete response rate of up to 6 cycles of VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in primary central nervous system lymphoma (PCNSL) and secondary central nervous system lymphoma (SCNSL) will be reported along with a 95% confidence interval. |
| Secondary | Proportion of Participants Overall Response Rate (Complete Response + Partial Response) to VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | After cycles 3 and 6 | The overall response rate of up to 6 cycles of VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in primary central nervous system lymphoma (PCNSL) and secondary central nervous system lymphoma (SCNSL) will be reported along with a 95% confidence interval. Complete response (CR) + Partial response (PR) was measured by the Lugano criteria. Complete response is disappearance of all detectable evidence of disease and disease-related symptoms. Partial response is a ≥50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. |
| Secondary | Overall Survival (OS) | Up to 2.6 years | Overall survival (OS) is defined as the duration of time from the date of study enrollment until time of death from any cause, or 10 years post-treatment whichever occurs first. Overall survival (OS) after VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in primary central nervous system lymphoma (PCNSL) and secondary central nervous system lymphoma (SCNSL) will be determined using a Kaplan-Meier curve. The median will be determined and presented with its associated 95% confidence interval. |
| Secondary | Progression Free Survival (PFS) | Up to 2.6 years | Progression-free survival (PFS) is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, death, or 10 years post-treatment, whichever occurs first. The progression-free survival (PFS) after VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in primary central nervous system lymphoma (PCNSL) and secondary central nervous system lymphoma (SCNSL) will be estimated using progression or death without progression as events, using a Kaplan-Meier curve. The median will be determined and presented with its associated 95% confidence interval. Progression was measured by the Lugano criteria and is appearance of any new nodal lesion ≥1.6 cm in greatest tumor dimension or ≥1.1 cm in short axis during or after the end of therapy, even if other lesions are decreasing in size. |
| Secondary | Duration of Response (DOR) | From date of first response until the date of recurrent or progressive disease is objectively documented, up to a max 2.6 years | The duration of response after VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in primary central nervous system lymphoma (PCNSL) and secondary central nervous system lymphoma (SCNSL) will be determined starting at the date a response is identified and will be estimated using a Kaplan-Meier curve along with a median DOR, and its associated 95% confidence interval. The duration of response (DOR) is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, death, or, in the absence of progressive disease (PD), date of last assessment. CR is disappearance of all detectable evidence of disease and disease-related symptoms. PR is a ≥50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Progression is appearance of any new nodal lesion. |
| 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 after the last dose of any study drug. Participants were followed for a maximum duration of 2.6 years. | 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
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants Who Completed at Least 2 Cycles of VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) Therapy Without Stopping Due to Toxicity | After 2 Cycles (each cycle is 21 days) | 9/10 participants were analyzed in Cohort 1, Arm 2 because 1 participant progressed before 2 cycles and was unevaluable. | proportion of participants | NUMBER |
| SECONDARY | Complete Response (CR) | After cycles 3 and 6 | 3/4 participants are analyzed in Arm 1 and 7/10 are analyzed in Arm 2 after cycle 3 because 1 patient in Arm 1 and 3 patients in Arm 2 did not complete 3 cycles of treatment and stopped earlier.~3/4 participants are analyzed in Arm 1 and 3/10 are analyzed in Arm 2 after cycle 6 because 1 patient in Arm 1 and 7 patients in Arm 2 did not complete 6 cycles of treatment and stopped earlier. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants Overall Response Rate (Complete Response + Partial Response) to VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | After cycles 3 and 6 | 3/4 participants are analyzed in Arm 1 and 7/10 are analyzed in Arm 2 after cycle 3 because 1 patient in Arm 1 and 3 patients in Arm 2 did not complete 3 cycles of treatment and stopped earlier.~3/4 participants are analyzed in Arm 1 and 3/10 are analyzed in Arm 2 after cycle 6 because 1 patient in Arm 1 and 7 patients in Arm 2 did not complete 6 cycles of treatment and stopped earlier. | proportion of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to 2.6 years | Months | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) | Up to 2.6 years | Months | MEDIAN | |
| SECONDARY | Duration of Response (DOR) | From date of first response until the date of recurrent or progressive disease is objectively documented, up to a max 2.6 years | Months | MEDIAN | |
| OTHER_PRE_SPECIFIED | 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 after the last dose of any study drug. Participants were followed for a maximum duration of 2.6 years. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants Who Completed at Least 2 Cycles of VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) Therapy Without Stopping Due to Toxicity | Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | 0.75 | 95% Confidence Interval 0.194 to 0.994 | proportion of participants | |
| Proportion of Participants Who Completed at Least 2 Cycles of VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) Therapy Without Stopping Due to Toxicity | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 1.0 | 95% Confidence Interval 0.664 to 1.000 | proportion of participants | |
| Complete Response (CR) | Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | After cycle 3 | 0.33 | 95% Confidence Interval 0.01 to 0.91 | proportion of participants |
| Complete Response (CR) | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | After cycle 3 | 0 | 95% Confidence Interval 0.0 to 0.41 | proportion of participants |
| Complete Response (CR) | Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | After cycle 6 | 0.67 | 95% Confidence Interval 0.09 to 0.99 | proportion of participants |
| Complete Response (CR) | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | After cycle 6 | 0.67 | 95% Confidence Interval 0.09 to 0.99 | proportion of participants |
| Proportion of Participants Overall Response Rate (Complete Response + Partial Response) to VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | After cycle 3 | 1.0 | 95% Confidence Interval 0.29 to 1.00 | proportion of participants |
| Proportion of Participants Overall Response Rate (Complete Response + Partial Response) to VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | After cycle 3 | 0.71 | 95% Confidence Interval 0.29 to 0.96 | proportion of participants |
| Proportion of Participants Overall Response Rate (Complete Response + Partial Response) to VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | After cycle 6 | 1.0 | 95% Confidence Interval 0.29 to 1.00 | proportion of participants |
| Proportion of Participants Overall Response Rate (Complete Response + Partial Response) to VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | After cycle 6 | 1.0 | 95% Confidence Interval 0.29 to 1.00 | proportion of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenalidomide+Nivolumab Followed by Ventoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide-Nivo | 4 | |
| Overall Study | STARTED | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 10 | |
| Overall Study | COMPLETED | Lenalidomide+Nivolumab Followed by Ventoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide-Nivo | 3 | |
| Overall Study | COMPLETED | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 3 | |
| Overall Study | NOT COMPLETED | Lenalidomide+Nivolumab Followed by Ventoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide-Nivo | 1 | |
| Overall Study | NOT COMPLETED | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 7 |
Source ClinicalTrials.gov
Adverse events150
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Agitation | Psychiatric disorders | Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | 1 | 4 | 1 |
| other | Agitation | Psychiatric disorders | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 0 | 10 | 0 |
| other | Alkaline phosphatase increased | Investigations | Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | 1 | 4 | 1 |
| other | Alkaline phosphatase increased | Investigations | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 0 | 10 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | 1 | 4 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 1 | 10 | 3 |
| other | Anorexia | Metabolism and nutrition disorders | Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | 0 | 4 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 1 | 10 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | 1 | 4 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 1 | 10 | 1 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | 2 | 4 |
| Total, all-cause mortality | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 6 | 10 |
| Total, other adverse events | Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | 4 | 4 |
| Total, other adverse events | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 9 | 10 |
| Total, serious adverse events | Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | 3 | 4 |
| Total, serious adverse events | Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 6 | 10 |
Source ClinicalTrials.gov
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo vs Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide): deaths from any cause | Trial comparisons |
Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo vs Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide): Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Trial comparisons |
Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo vs Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide): serious adverse events | Trial comparisons |
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/NCT05211336
GET https://conductscience.org/api/trials/v1/NCT05211336/events?page=2