Trial Outcomes & Findings for Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System (NCT NCT05211336)

Last Updated: 2026-01-08

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

After 2 Cycles (each cycle is 21 days)

Results posted on

2026-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Lenalidomide+Nivolumab Followed by Ventoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide-Nivo Cohort 1, Arm 1: Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). Experimental - Nivolumab on Day 1 with lenalidomide (days 1-14) for a 21-day cycle. Following Window, VIPOR-Nivo (venetoclax, ibrutinib, prednisone, Obinutuzumab, lenalidomide, and nivolumab) in 21-day cycles for up to 6 cycles.	Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in 21-day cycles for up to 6 cycles.
Overall Study STARTED	4	10
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	1	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Lenalidomide+Nivolumab Followed by Ventoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide-Nivo Cohort 1, Arm 1: Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). Experimental - Nivolumab on Day 1 with lenalidomide (days 1-14) for a 21-day cycle. Following Window, VIPOR-Nivo (venetoclax, ibrutinib, prednisone, Obinutuzumab, lenalidomide, and nivolumab) in 21-day cycles for up to 6 cycles.	Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in 21-day cycles for up to 6 cycles.
Overall Study Unacceptable adverse event - autoimmune hepatitis	1	0
Overall Study Progressive disease	0	4
Overall Study Death due to myocardial infarction	0	1
Overall Study Death due to unknown cause	0	1
Overall Study Worsening kidney function and quality of response	0	1

Baseline Characteristics

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo n=4 Participants Cohort 1, Arm 1: Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). Experimental - Nivolumab on Day 1 with lenalidomide (days 1-14) for a 21-day cycle. Following Window, VIPOR-Nivo (venetoclax, ibrutinib, prednisone, Obinutuzumab, lenalidomide, and nivolumab) in 21-day cycles for up to 6 cycles.	Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) n=10 Participants Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in 21-day cycles for up to 6 cycles.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=18 Participants	5 Participants n=17 Participants	7 Participants n=35 Participants
Age, Categorical >=65 years	2 Participants n=18 Participants	5 Participants n=17 Participants	7 Participants n=35 Participants
Age, Continuous	67.5 years STANDARD_DEVIATION 16.66 • n=18 Participants	63.3 years STANDARD_DEVIATION 12.3 • n=17 Participants	64.5 years STANDARD_DEVIATION 13.14 • n=35 Participants
Sex: Female, Male Female	0 Participants n=18 Participants	5 Participants n=17 Participants	5 Participants n=35 Participants
Sex: Female, Male Male	4 Participants n=18 Participants	5 Participants n=17 Participants	9 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=18 Participants	5 Participants n=17 Participants	6 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=18 Participants	4 Participants n=17 Participants	7 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	1 Participants n=17 Participants	1 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	0 Participants n=18 Participants	1 Participants n=17 Participants	1 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	0 Participants n=18 Participants	3 Participants n=17 Participants	3 Participants n=35 Participants
Race (NIH/OMB) White	4 Participants n=18 Participants	6 Participants n=17 Participants	10 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Region of Enrollment United States	4 participants n=18 Participants	10 participants n=17 Participants	14 participants n=35 Participants
Disease Category (Primary/Secondary Central Nervous System Lymphoma) Primary	3 Participants n=18 Participants	6 Participants n=17 Participants	9 Participants n=35 Participants
Disease Category (Primary/Secondary Central Nervous System Lymphoma) Secondary	1 Participants n=18 Participants	4 Participants n=17 Participants	5 Participants n=35 Participants

PRIMARY outcome

Timeframe: After 2 Cycles (each cycle is 21 days)

Population: 9/10 participants were analyzed in Cohort 1, Arm 2 because 1 participant progressed before 2 cycles and was unevaluable.

Outcome measures

Outcome measures
Measure	Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo n=4 Participants Cohort 1, Arm 1: Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). Experimental - Nivolumab on Day 1 with lenalidomide (days 1-14) for a 21-day cycle. Following Window, VIPOR-Nivo (venetoclax, ibrutinib, prednisone, Obinutuzumab, lenalidomide, and nivolumab) in 21-day cycles for up to 6 cycles.	Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) n=9 Participants Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in 21-day cycles for up to 6 cycles.
Proportion of Participants Who Completed at Least 2 Cycles of VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) Therapy Without Stopping Due to Toxicity	0.75 proportion of participants Interval 0.194 to 0.994	1.0 proportion of participants Interval 0.664 to 1.0

SECONDARY outcome

Timeframe: After cycles 3 and 6

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo n=3 Participants Cohort 1, Arm 1: Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). Experimental - Nivolumab on Day 1 with lenalidomide (days 1-14) for a 21-day cycle. Following Window, VIPOR-Nivo (venetoclax, ibrutinib, prednisone, Obinutuzumab, lenalidomide, and nivolumab) in 21-day cycles for up to 6 cycles.	Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) n=7 Participants Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in 21-day cycles for up to 6 cycles.
Complete Response (CR) After cycle 3	0.33 proportion of participants Interval 0.01 to 0.91	0 proportion of participants Interval 0.0 to 0.41
Complete Response (CR) After cycle 6	0.67 proportion of participants Interval 0.09 to 0.99	0.67 proportion of participants Interval 0.09 to 0.99

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo n=3 Participants Cohort 1, Arm 1: Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). Experimental - Nivolumab on Day 1 with lenalidomide (days 1-14) for a 21-day cycle. Following Window, VIPOR-Nivo (venetoclax, ibrutinib, prednisone, Obinutuzumab, lenalidomide, and nivolumab) in 21-day cycles for up to 6 cycles.	Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) n=7 Participants Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in 21-day cycles for up to 6 cycles.
Proportion of Participants Overall Response Rate (Complete Response + Partial Response) to VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) After cycle 3	1.0 proportion of participants Interval 0.29 to 1.0	0.71 proportion of participants Interval 0.29 to 0.96
Proportion of Participants Overall Response Rate (Complete Response + Partial Response) to VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) After cycle 6	1.0 proportion of participants Interval 0.29 to 1.0	1.0 proportion of participants Interval 0.29 to 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo n=4 Participants Cohort 1, Arm 1: Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). Experimental - Nivolumab on Day 1 with lenalidomide (days 1-14) for a 21-day cycle. Following Window, VIPOR-Nivo (venetoclax, ibrutinib, prednisone, Obinutuzumab, lenalidomide, and nivolumab) in 21-day cycles for up to 6 cycles.	Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) n=10 Participants Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in 21-day cycles for up to 6 cycles.
Overall Survival (OS)	23.4 Months Interval 4.3 to The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash.	10.4 Months Interval 3.6 to The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo n=4 Participants Cohort 1, Arm 1: Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). Experimental - Nivolumab on Day 1 with lenalidomide (days 1-14) for a 21-day cycle. Following Window, VIPOR-Nivo (venetoclax, ibrutinib, prednisone, Obinutuzumab, lenalidomide, and nivolumab) in 21-day cycles for up to 6 cycles.	Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) n=10 Participants Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in 21-day cycles for up to 6 cycles.
Progression Free Survival (PFS)	8.4 Months Interval 4.3 to The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash.	3.0 Months Interval 2.0 to The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo n=4 Participants Cohort 1, Arm 1: Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). Experimental - Nivolumab on Day 1 with lenalidomide (days 1-14) for a 21-day cycle. Following Window, VIPOR-Nivo (venetoclax, ibrutinib, prednisone, Obinutuzumab, lenalidomide, and nivolumab) in 21-day cycles for up to 6 cycles.	Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) n=10 Participants Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in 21-day cycles for up to 6 cycles.
Duration of Response (DOR) Complete Response	21.9 Months Interval 12.0 to The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash	7.2 Months Interval 5.2 to The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash
Duration of Response (DOR) Partial Response	4.9 Months The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash	4.8 Months Interval 3.6 to The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo n=4 Participants Cohort 1, Arm 1: Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). Experimental - Nivolumab on Day 1 with lenalidomide (days 1-14) for a 21-day cycle. Following Window, VIPOR-Nivo (venetoclax, ibrutinib, prednisone, Obinutuzumab, lenalidomide, and nivolumab) in 21-day cycles for up to 6 cycles.	Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) n=10 Participants Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in 21-day cycles for up to 6 cycles.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).	4 Participants	9 Participants

Adverse Events

Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo

Serious events: 3 serious events

Other events: 4 other events

Deaths: 2 deaths

Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide)

Serious events: 6 serious events

Other events: 9 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Rahul Lakhotia

National Cancer Institute

Phone: 240-858.7242

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo n=4 participants at risk Cohort 1, Arm 1: Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). Experimental - Nivolumab on Day 1 with lenalidomide (days 1-14) for a 21-day cycle. Following Window, VIPOR-Nivo (venetoclax, ibrutinib, prednisone, Obinutuzumab, lenalidomide, and nivolumab) in 21-day cycles for up to 6 cycles.	Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) n=10 participants at risk Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in 21-day cycles for up to 6 cycles.
Investigations Alanine aminotransferase increased	25.0% 1/4 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	0.00% 0/10 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Investigations Aspartate aminotransferase increased	25.0% 1/4 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	0.00% 0/10 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Cardiac disorders Atrial fibrillation	25.0% 1/4 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	0.00% 0/10 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Cardiac disorders Atrial flutter	0.00% 0/4 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Cardiac disorders Conduction disorder	25.0% 1/4 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	0.00% 0/10 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Gastrointestinal disorders Diarrhea	25.0% 1/4 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	0.00% 0/10 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Injury, poisoning and procedural complications Fall	0.00% 0/4 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
General disorders Fatigue	0.00% 0/4 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	10.0% 1/10 • Number of events 2 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Renal and urinary disorders Hepatobiliary disorders - Other, drug induces liver injury	25.0% 1/4 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	0.00% 0/10 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Infections and infestations Infections and infestations - Other, COVID-19	25.0% 1/4 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Infections and infestations Lung infection	0.00% 0/4 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Cardiac disorders Myocardial infarction	0.00% 0/4 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	10.0% 1/10 • Number of events 2 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Nervous system disorders Presyncope	25.0% 1/4 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	0.00% 0/10 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Nervous system disorders Seizure	25.0% 1/4 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Infections and infestations Sepsis	0.00% 0/4 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Nervous system disorders Stroke	0.00% 0/4 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.
Nervous system disorders Syncope	25.0% 1/4 • Number of events 3 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.	0.00% 0/10 • All-Cause Mortality and 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. Participants were followed for a maximum duration of 2.6 years.