Trial Outcomes & Findings for Obinutuzumab in Combination With Ibrutinib in Treating Patients With Relapsed Mantle Cell Lymphoma (NCT NCT02736617)

Last Updated: 2022-01-05

Results Overview

Overall response is measured combining bone marrow biopsy with CT or PET, measuring target and evaluable non-targeted lesions, according to the Lugano criteria. For FDG-PET, the Deauville criteria is used in conjecture with CT to assess lesion FDG-update. Deauville scale ranges from 1 to 5, where 1 is best (no uptake or no residual uptake) and 5 is worst (markedly increased uptake or any new lesion). If bone marrow is involved prior to treatment, infiltrate must have cleared on repeat biopsy for CR; bone marrow assessment is irrelevant for determination of PR. Measurements are taken at baseline, end of cycle 2, end of induction (after cycle 6) and every 4 months thereafter. Best overall response is any CR or PR reported since start of therapy. Percent of participants with complete response or partial response (CR+PR) are reported along with 95% confidence interval.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

From first dose of study therapy until the 6-month disease assessment (Cycle 6, Day1 or End of Induction Day 28). Disease assessment is also assessed at end of Cycle 2 (2-months).

Results posted on

2022-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Overall Study Participants receive 1000mg Obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib once daily by mouth on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have at least partial response (PR) will continue to receive obinutuzumab IV every 2 months and oral ibrutinib for 2 years in the absence of disease progression or unacceptable toxicity.
Treatment STARTED	10
Treatment COMPLETED	7
Treatment NOT COMPLETED	3
Maintenance STARTED	7
Maintenance COMPLETED	2
Maintenance NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Study Participants receive 1000mg Obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib once daily by mouth on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have at least partial response (PR) will continue to receive obinutuzumab IV every 2 months and oral ibrutinib for 2 years in the absence of disease progression or unacceptable toxicity.
Treatment Adverse Event	1
Treatment Lack of Efficacy	1
Treatment Withdrawal by Subject	1
Maintenance Lack of Efficacy	4
Maintenance Physician Decision	1

Baseline Characteristics

Obinutuzumab in Combination With Ibrutinib in Treating Patients With Relapsed Mantle Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=10 Participants Participants who receive at least one dose of either study drug.
Age, Continuous	72.0 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	10 Participants n=5 Participants
Disease status at enrollment Stable Disease	5 Participants n=5 Participants
Disease status at enrollment Progressive Disease	5 Participants n=5 Participants
Mantle Cell Lymphoma International Prognositic Index (MIPI) Risk Class Intermediate Risk	3 Participants n=5 Participants
Mantle Cell Lymphoma International Prognositic Index (MIPI) Risk Class High Risk	7 Participants n=5 Participants
Ki-67 positivity, % (proliferation marker)	65 percent positive nuclei in field n=5 Participants
Eastern Cooperative Oncology Group (ECOG) at screening ECOG 0	1 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) at screening ECOG 1	9 Participants n=5 Participants
Months between diagnosis and enrollment	21.5 Months n=5 Participants

PRIMARY outcome

Timeframe: From first dose of study therapy until the 6-month disease assessment (Cycle 6, Day1 or End of Induction Day 28). Disease assessment is also assessed at end of Cycle 2 (2-months).

Population: Efficacy evaluable population: those who receive at least one dose of both study drugs and had one response assessment (after cycle 2). Any patient who clinically progresses prior to their first scheduled response assessment will be included in the efficacy set and will be counted as a non-responder.

Outcome measures

Outcome measures
Measure	Efficacy Evaluable n=9 Participants Participants who receive at least one dose of both study drugs and have one response assessment (after cycle 2) are eligible for the efficacy evaluable set. Participants progressing prior to the first scheduled response assessment are counted as non-responders. Evaluable participants who do not have response assessments (e.g. are removed for toxicity) are also counted as non-responders. All other progressions must be confirmed by imaging. One participant withdrew consent 6 days after starting study therapy and was considered ineligible for the efficacy evaluable set.
Percent of Participants With Best Overall Objective Response or Complete Response/Partial Response (CR/PR)	89 percentage of participants Interval 62.0 to 100.0

SECONDARY outcome

Timeframe: Time from the first day of combined study treatment to disease progression or death, whichever occurs first, assessed up to approximately 4 years, 11 months, after first dose of study drug(s)

Median progression free survival is measured from first day of study therapy until disease progression or death, whichever comes first. Participants who progress prior to their first scheduled disease assessment are considered to have clinically progressed. Participants who do not progress are censored at the time of their last disease assessment. The Kaplan-Meier method is used to estimate median PFS. 95% confidence interval is provided, although upper limit was not achieved (insufficient number of progressions)

Outcome measures

Outcome measures
Measure	Efficacy Evaluable n=9 Participants Participants who receive at least one dose of both study drugs and have one response assessment (after cycle 2) are eligible for the efficacy evaluable set. Participants progressing prior to the first scheduled response assessment are counted as non-responders. Evaluable participants who do not have response assessments (e.g. are removed for toxicity) are also counted as non-responders. All other progressions must be confirmed by imaging. One participant withdrew consent 6 days after starting study therapy and was considered ineligible for the efficacy evaluable set.
Progression Free Survival (PFS)	14 months Interval 6.9 to Too few participants progressed to calculate the upper limit of the 95% confidence interval

SECONDARY outcome

Timeframe: Measured from the first dose of either study drug until 30 days after the last dose of study drug, for approximately 4 years, 11 months.

Population: All participants receiving at least 1 dose of IV Obinutuzumab or oral Ibrutinib

Defined as any adverse event grade 3 or higher, classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, from the first dose of study drug(s) until 30 days after the last dose of study drug(s)

Outcome measures

Outcome measures
Measure	Efficacy Evaluable n=10 Participants Participants who receive at least one dose of both study drugs and have one response assessment (after cycle 2) are eligible for the efficacy evaluable set. Participants progressing prior to the first scheduled response assessment are counted as non-responders. Evaluable participants who do not have response assessments (e.g. are removed for toxicity) are also counted as non-responders. All other progressions must be confirmed by imaging. One participant withdrew consent 6 days after starting study therapy and was considered ineligible for the efficacy evaluable set.
Number of Participants With Treatment-related Toxicities, Grade 3 or Higher, as Assessed by CTCAE v4.0 Infections and infestations	1 participants
Number of Participants With Treatment-related Toxicities, Grade 3 or Higher, as Assessed by CTCAE v4.0 Infusion related reaction	1 participants
Number of Participants With Treatment-related Toxicities, Grade 3 or Higher, as Assessed by CTCAE v4.0 Neutrophil count decreased	4 participants
Number of Participants With Treatment-related Toxicities, Grade 3 or Higher, as Assessed by CTCAE v4.0 Platelet count decreased	2 participants
Number of Participants With Treatment-related Toxicities, Grade 3 or Higher, as Assessed by CTCAE v4.0 Stroke	1 participants

Adverse Events

Overall Study

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Overall Study n=10 participants at risk Participants receive 1000mg Obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib once daily by mouth on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have at least partial response (PR) will continue to receive obinutuzumab IV every 2 months and oral ibrutinib for 2 years in the absence of disease progression or unacceptable toxicity.
Infections and infestations Infections and infestations - Other, specify	20.0% 2/10 • Number of events 2 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Injury, poisoning and procedural complications Infusion related reaction	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Nervous system disorders Somnolence	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Nervous system disorders Stroke	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.

Other adverse events

Other adverse events
Measure	Overall Study n=10 participants at risk Participants receive 1000mg Obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib once daily by mouth on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have at least partial response (PR) will continue to receive obinutuzumab IV every 2 months and oral ibrutinib for 2 years in the absence of disease progression or unacceptable toxicity.
Infections and infestations Wound infection	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Skin and subcutaneous tissue disorders Alopecia	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Metabolism and nutrition disorders Anorexia	30.0% 3/10 • Number of events 4 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	30.0% 3/10 • Number of events 5 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Cardiac disorders Atrial fibrillation	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Investigations Blood bilirubin increased	20.0% 2/10 • Number of events 2 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Musculoskeletal and connective tissue disorders Bone pain	30.0% 3/10 • Number of events 3 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Injury, poisoning and procedural complications Bruising	40.0% 4/10 • Number of events 5 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Cardiac disorders Cardiac disorders - Other, specify	20.0% 2/10 • Number of events 3 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Musculoskeletal and connective tissue disorders Chest wall pain	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Psychiatric disorders Confusion	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Psychiatric disorders Depression	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Gastrointestinal disorders Diarrhea	30.0% 3/10 • Number of events 3 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Nervous system disorders Dizziness	10.0% 1/10 • Number of events 2 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 2/10 • Number of events 3 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
General disorders Edema limbs	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.0% 1/10 • Number of events 3 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Eye disorders Eye disorders - Other, specify	20.0% 2/10 • Number of events 3 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Injury, poisoning and procedural complications Fall	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
General disorders Fatigue	30.0% 3/10 • Number of events 7 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
General disorders Fever	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Gastrointestinal disorders Gastritis	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	30.0% 3/10 • Number of events 6 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	10.0% 1/10 • Number of events 2 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Ear and labyrinth disorders Hearing impaired	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Gastrointestinal disorders Hemorrhoids	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Vascular disorders Hypertension	40.0% 4/10 • Number of events 4 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Infections and infestations Infections and infestations - Other, specify	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Injury, poisoning and procedural complications Infusion related reaction	30.0% 3/10 • Number of events 3 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	10.0% 1/10 • Number of events 2 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 2/10 • Number of events 2 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Skin and subcutaneous tissue disorders Nail loss	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Gastrointestinal disorders Nausea	40.0% 4/10 • Number of events 4 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Nervous system disorders Nervous system disorders - Other, specify	40.0% 4/10 • Number of events 7 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Nervous system disorders Neuralgia	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Investigations Neutrophil count decreased	40.0% 4/10 • Number of events 15 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Gastrointestinal disorders Oral hemorrhage	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Infections and infestations Otitis media	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
General disorders Pain	20.0% 2/10 • Number of events 2 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	30.0% 3/10 • Number of events 4 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Cardiac disorders Palpitations	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Investigations Platelet count decreased	40.0% 4/10 • Number of events 8 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Respiratory, thoracic and mediastinal disorders Productive cough	20.0% 2/10 • Number of events 2 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Skin and subcutaneous tissue disorders Pruritus	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Skin and subcutaneous tissue disorders Rash acneiform	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Skin and subcutaneous tissue disorders Rash maculo-papular	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Renal and urinary disorders Renal and urinary disorders - Other, specify	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Infections and infestations Sinusitis	20.0% 2/10 • Number of events 5 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	50.0% 5/10 • Number of events 7 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Cardiac disorders Supraventricular tachycardia	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Infections and infestations Tooth infection	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Infections and infestations Upper respiratory infection	40.0% 4/10 • Number of events 4 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Renal and urinary disorders Urinary incontinence	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Investigations Weight gain	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Investigations Weight loss	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Injury, poisoning and procedural complications Wound dehiscence	10.0% 1/10 • Number of events 1 • From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months) All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.

Additional Information

Dr. Stephen E. Spurgeon, Associate Professor of Medicine

Oregon Health and Sciences University, Knight Cancer Institute

Phone: 503-494-8950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place