Trial Outcomes & Findings for A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma (NCT NCT03323151)
NCT ID: NCT03323151
Last Updated: 2024-01-18
Results Overview
To determine the maximum tolerable dose (MTD) of ixazomib (mg) in combination with ibrutinib (mg) in patients with relapsed/refractory mantle cell lymphoma (MCL) using DLT endpoint.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
43 participants
Primary outcome timeframe
1 month
Results posted on
2024-01-18
Participant Flow
Participant milestones
| Measure |
Phase I: Ixazomib & Ibrutinib (Dose Level 1)
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 3 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle. Dose may be escalated (Ixazomib 4 mg) dependent on dose-limiting toxicities. Note: Ixazomib dose will not be de-escalated but remain at 3 mg.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Phase I: Ixazomib & Ibrutinib (Dose Level 2)
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Phase II: Ixazomib & BTK Pre-Treated
Patients previously treated with a BTK will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
Phase II: Ixazomib & BTK-Naive
Patients who are BTK-Naive will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
9
|
4
|
27
|
|
Overall Study
COMPLETED
|
3
|
9
|
4
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Phase I: Ixazomib & Ibrutinib (Dose Level 1)
n=3 Participants
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
|
Phase I: Ixazomib & Ibrutinib (Dose Level 2)
n=9 Participants
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
|
Phase II: Ixazomib & BTK Pre-Treated
n=4 Participants
Patients previously treated with a BTK will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
Phase II: Ixazomib & BTK-Naive
n=27 Participants
Patients who are BTK-Naive will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Age, Continuous
|
67 years
n=5 Participants
|
73 years
n=7 Participants
|
74 years
n=5 Participants
|
70 years
n=4 Participants
|
70 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
9 participants
n=7 Participants
|
4 participants
n=5 Participants
|
27 participants
n=4 Participants
|
43 participants
n=21 Participants
|
|
Ann Arbor Stage
Stage IE
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ann Arbor Stage
Stage II
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ann Arbor Stage
Stage III
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ann Arbor Stage
Stage IV
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
ECOG Performance Status
0
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
ECOG Performance Status
1
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
ECOG Performance Status
2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Number of Prior Lines of Treatment
1
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Number of Prior Lines of Treatment
2
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Number of Prior Lines of Treatment
3
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Number of Prior Lines of Treatment
4
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
MCL International Prognostic Index-c (MIPI-c) Category
Low
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
MCL International Prognostic Index-c (MIPI-c) Category
Low/Intermediate
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
MCL International Prognostic Index-c (MIPI-c) Category
High/intermediate and High
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
MCL International Prognostic Index-c (MIPI-c) Category
Indeterminate
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 monthTo determine the maximum tolerable dose (MTD) of ixazomib (mg) in combination with ibrutinib (mg) in patients with relapsed/refractory mantle cell lymphoma (MCL) using DLT endpoint.
Outcome measures
| Measure |
Phase I: Ixazomib & Ibrutinib (Dose Level 1)
n=3 Participants
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 3 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle. Dose may be escalated (Ixazomib 4 mg) dependent on dose-limiting toxicities. Note: Ixazomib dose will not be de-escalated but remain at 3 mg.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Phase I: Ixazomib & Ibrutinib (Dose Level 2)
n=9 Participants
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Ixazomib & BTK Pre-Treated
Patients previously treated with a BTK will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
Phase II: Ixazomib & BTK-Naive
Patients who are BTK-Naive will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Phase I: Dose Limiting Toxicities (DLT) Rate
Dose Limiting Toxicity = No
|
3 Participants
|
5 Participants
|
—
|
—
|
|
Phase I: Dose Limiting Toxicities (DLT) Rate
Dose Limiting Toxicity = Yes
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Phase I: Dose Limiting Toxicities (DLT) Rate
Unevaluable for Dose Limiting Toxicity
|
0 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Eligible and treated patients
CR rate will be the defined as the percentage of patients achieving CR as confirmed by bone marrow biopsy within the first 12 months of initiating treatment. Response to treatment was assessed using the Lugano classification criteria. Patients completed a PET/CT at the time of study enrollment and were restaged at cycles 3, 6, 9, and 12, and then every 6 months while on study therapy. All patients with suspected CR who had bone marrow involvement at screening underwent a bone marrow biopsy to confirm response.
Outcome measures
| Measure |
Phase I: Ixazomib & Ibrutinib (Dose Level 1)
n=4 Participants
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 3 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle. Dose may be escalated (Ixazomib 4 mg) dependent on dose-limiting toxicities. Note: Ixazomib dose will not be de-escalated but remain at 3 mg.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Phase I: Ixazomib & Ibrutinib (Dose Level 2)
n=27 Participants
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Ixazomib & BTK Pre-Treated
Patients previously treated with a BTK will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
Phase II: Ixazomib & BTK-Naive
Patients who are BTK-Naive will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Phase II: Complete Response Rate
Complete Response
|
0 Participants
|
11 Participants
|
—
|
—
|
|
Phase II: Complete Response Rate
Partial Response
|
2 Participants
|
10 Participants
|
—
|
—
|
|
Phase II: Complete Response Rate
Stable Disease
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Phase II: Complete Response Rate
Progressive Disease
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Phase II: Complete Response Rate
Unevaluable
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase I: 12 months; Phase II: 36 monthsNumber of patients with abnormal laboratory values and/or adverse events (defined as a new untoward medical occurrence or worsening of a pre-existing medical condition) related to study treatment. Grades refer to the severity of the adverse event, where grade 1 through 5 signifies mild, moderate, severe, life-threatening, and death respectively.
Outcome measures
| Measure |
Phase I: Ixazomib & Ibrutinib (Dose Level 1)
n=3 Participants
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 3 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle. Dose may be escalated (Ixazomib 4 mg) dependent on dose-limiting toxicities. Note: Ixazomib dose will not be de-escalated but remain at 3 mg.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Phase I: Ixazomib & Ibrutinib (Dose Level 2)
n=9 Participants
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Ixazomib & BTK Pre-Treated
n=4 Participants
Patients previously treated with a BTK will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
Phase II: Ixazomib & BTK-Naive
n=27 Participants
Patients who are BTK-Naive will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Grade 3
|
3 Participants
|
7 Participants
|
3 Participants
|
18 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Phase I: 12 months; Phase II: 12 monthsORR assessed in accordance with Lugano classification
Outcome measures
| Measure |
Phase I: Ixazomib & Ibrutinib (Dose Level 1)
n=3 Participants
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 3 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle. Dose may be escalated (Ixazomib 4 mg) dependent on dose-limiting toxicities. Note: Ixazomib dose will not be de-escalated but remain at 3 mg.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Phase I: Ixazomib & Ibrutinib (Dose Level 2)
n=9 Participants
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Ixazomib & BTK Pre-Treated
n=4 Participants
Patients previously treated with a BTK will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
Phase II: Ixazomib & BTK-Naive
n=27 Participants
Patients who are BTK-Naive will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
Complete (CR) or Partial Response (PR)
|
2 Participants
|
6 Participants
|
2 Participants
|
21 Participants
|
|
Overall Response Rate (ORR)
Non-CR/-PR
|
1 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Phase I & II: 48 monthsPFS assessed in accordance with Lugano classification
Outcome measures
| Measure |
Phase I: Ixazomib & Ibrutinib (Dose Level 1)
n=3 Participants
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 3 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle. Dose may be escalated (Ixazomib 4 mg) dependent on dose-limiting toxicities. Note: Ixazomib dose will not be de-escalated but remain at 3 mg.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Phase I: Ixazomib & Ibrutinib (Dose Level 2)
n=9 Participants
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Ixazomib & BTK Pre-Treated
n=4 Participants
Patients previously treated with a BTK will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
Phase II: Ixazomib & BTK-Naive
n=27 Participants
Patients who are BTK-Naive will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
17.12 Months
Interval 2.56 to 36.44
|
27.43 Months
Interval 5.78 to 29.17
|
14.16 Months
Interval 2.14 to 14.16
|
29.83 Months
Interval 8.28 to 35.12
|
SECONDARY outcome
Timeframe: Phase I & II: 48 monthsOS assessed during clinic visit or by reaching out to patients to confirm vital status.
Outcome measures
| Measure |
Phase I: Ixazomib & Ibrutinib (Dose Level 1)
n=3 Participants
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 3 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle. Dose may be escalated (Ixazomib 4 mg) dependent on dose-limiting toxicities. Note: Ixazomib dose will not be de-escalated but remain at 3 mg.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Phase I: Ixazomib & Ibrutinib (Dose Level 2)
n=9 Participants
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Ixazomib & BTK Pre-Treated
n=4 Participants
Patients previously treated with a BTK will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
Phase II: Ixazomib & BTK-Naive
n=27 Participants
Patients who are BTK-Naive will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
27.01 Months
Interval 20.01 to 51.15
|
47.74 Months
Interval 25.17 to 47.74
|
29.17 Months
Interval 14.16 to 37.06
|
35.68 Months
Interval 29.83 to 35.68
|
Adverse Events
Phase I: Ixazomib & Ibrutinib (Dose Level 1)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase I: Ixazomib & Ibrutinib (Dose Level 2)
Serious events: 7 serious events
Other events: 9 other events
Deaths: 4 deaths
Phase II: Ixazomib & BTK Pre-Treated
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase II: Ixazomib & BTK-Naive
Serious events: 10 serious events
Other events: 27 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Phase I: Ixazomib & Ibrutinib (Dose Level 1)
n=3 participants at risk
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 3 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle. Dose may be escalated (Ixazomib 4 mg) dependent on dose-limiting toxicities. Note: Ixazomib dose will not be de-escalated but remain at 3 mg.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Phase I: Ixazomib & Ibrutinib (Dose Level 2)
n=9 participants at risk
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Phase II: Ixazomib & BTK Pre-Treated
n=4 participants at risk
Patients previously treated with a BTK will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
Phase II: Ixazomib & BTK-Naive
n=27 participants at risk
Patients who are BTK-Naive will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
7.4%
2/27 • Number of events 2 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Number of events 2 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
Other adverse events
| Measure |
Phase I: Ixazomib & Ibrutinib (Dose Level 1)
n=3 participants at risk
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 3 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle. Dose may be escalated (Ixazomib 4 mg) dependent on dose-limiting toxicities. Note: Ixazomib dose will not be de-escalated but remain at 3 mg.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Phase I: Ixazomib & Ibrutinib (Dose Level 2)
n=9 participants at risk
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
|
Phase II: Ixazomib & BTK Pre-Treated
n=4 participants at risk
Patients previously treated with a BTK will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
Phase II: Ixazomib & BTK-Naive
n=27 participants at risk
Patients who are BTK-Naive will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Ixazomib: Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
44.4%
4/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
50.0%
2/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
55.6%
15/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
25.0%
1/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
25.9%
7/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
33.3%
9/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
7.4%
2/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
3/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
29.6%
8/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Injury, poisoning and procedural complications
Contusion
|
66.7%
2/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
33.3%
3/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
25.9%
7/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
14.8%
4/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
22.2%
2/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
18.5%
5/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
18.5%
5/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
18.5%
5/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
General disorders
Fatigue
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
44.4%
4/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
75.0%
3/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
59.3%
16/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
3/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
25.9%
7/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
25.0%
1/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
29.6%
8/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
7.4%
2/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
14.8%
4/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
3/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
18.5%
5/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
33.3%
3/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
25.0%
1/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
55.6%
15/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Investigations
Neutrophil Count Decreased
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
22.2%
2/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
14.8%
4/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
General disorders
Oedema Peripheral
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
22.2%
2/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
25.9%
7/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
33.3%
3/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
25.0%
1/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
25.9%
7/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
22.2%
2/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
14.8%
4/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Investigations
Platelet Count Decreased
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
22.2%
2/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
50.0%
2/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
37.0%
10/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
44.4%
4/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
25.0%
1/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
22.2%
6/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
18.5%
5/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
3/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
44.4%
4/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
7.4%
2/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
22.2%
2/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
33.3%
9/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
22.2%
2/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
25.0%
1/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
7.4%
2/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
22.2%
2/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
3.7%
1/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
7.4%
2/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
7.4%
2/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
25.0%
1/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
7.4%
2/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
General disorders
Chills
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
18.5%
5/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
22.2%
2/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
18.5%
5/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
7.4%
2/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
3/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
11.1%
1/9 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
0.00%
0/4 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
7.4%
2/27 • Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.
All serious adverse events and all-cause mortality, regardless of treatment attribution, are reported
|
Additional Information
Opeyemi Jegede, Statistician
ECOG-ACRIN Statistical Center
Phone: 617-582-7613
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place