Trial Outcomes & Findings for Ixazomib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma (NCT NCT04047797)
NCT ID: NCT04047797
Last Updated: 2025-04-20
Results Overview
Evaluate the complete remission rate of BTK inhibitor refractory MCL patients with ixazomib and rituximab at 16 weeks of therapy. Complete remission at 16 weeks was measured by PET/CT or CT imaging using Lugano Criteria 2014.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
16 weeks
Results posted on
2025-04-20
Participant Flow
Open label, single center, single-arm, phase II
Participant milestones
| Measure |
Study Drug
Ixazomib 4mg PO on days 1, 8, 15 Rituximab 375 mg/m2 IV weekly until cycle 3, then given day 1 of each cycle
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Study Drug
Ixazomib 4mg PO on days 1, 8, 15 Rituximab 375 mg/m2 IV weekly until cycle 3, then given day 1 of each cycle
|
|---|---|
|
Overall Study
Progressive Disease
|
1
|
Baseline Characteristics
Ixazomib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Study Drug
n=3 Participants
Ixazomib 4mg PO on days 1, 8, 15 Rituximab 375 mg/m2 IV weekly until cycle 3, then given day 1 of each cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All endpoints will be measured on patients that received at least one dose of the study drug
Evaluate the complete remission rate of BTK inhibitor refractory MCL patients with ixazomib and rituximab at 16 weeks of therapy. Complete remission at 16 weeks was measured by PET/CT or CT imaging using Lugano Criteria 2014.
Outcome measures
| Measure |
Study Drug
n=3 Participants
Ixazomib 4mg PO on days 1, 8, 15 Rituximab 375 mg/m2 IV weekly until cycle 3, then given day 1 of each cycle
|
|---|---|
|
Complete Remission Rate at 16 Weeks
|
3 Participants
|
SECONDARY outcome
Timeframe: 16 weeksEvaluate the overall response rate (ORR) assessed by Lugano criteria (2014)
Outcome measures
| Measure |
Study Drug
n=3 Participants
Ixazomib 4mg PO on days 1, 8, 15 Rituximab 375 mg/m2 IV weekly until cycle 3, then given day 1 of each cycle
|
|---|---|
|
Overall Response Rate at 16 Weeks
|
3 Participants
|
SECONDARY outcome
Timeframe: 16 weeksEvaluate progression free survival and overall survival
Outcome measures
| Measure |
Study Drug
n=3 Participants
Ixazomib 4mg PO on days 1, 8, 15 Rituximab 375 mg/m2 IV weekly until cycle 3, then given day 1 of each cycle
|
|---|---|
|
Progression Free Survival (PFS) and Overall Survival (OS)
Overall survival (OS)
|
3 Participants
|
|
Progression Free Survival (PFS) and Overall Survival (OS)
Complete Metabolic Response (CMR)
|
2 Participants
|
SECONDARY outcome
Timeframe: time of first dose of ixazomib through 30 days after the last dose of ixazomib was administered, up to 140 weeks.Tolerability of study drug at weeks 8, 16, 28, 42, and 56 using CTCAE v4.0 Toxicities or Adverse Events (grade 3 and up) were measured using CTCAE v 4.0 to determine the tolerability of ixazomib.
Outcome measures
| Measure |
Study Drug
n=3 Participants
Ixazomib 4mg PO on days 1, 8, 15 Rituximab 375 mg/m2 IV weekly until cycle 3, then given day 1 of each cycle
|
|---|---|
|
Tolerability of Study Drug at Weeks 8, 16, 28, 42, and 56
Week 8
|
0 Participants
|
|
Tolerability of Study Drug at Weeks 8, 16, 28, 42, and 56
Week 16
|
0 Participants
|
|
Tolerability of Study Drug at Weeks 8, 16, 28, 42, and 56
Week 28
|
0 Participants
|
|
Tolerability of Study Drug at Weeks 8, 16, 28, 42, and 56
Week 42
|
0 Participants
|
|
Tolerability of Study Drug at Weeks 8, 16, 28, 42, and 56
Week 56
|
0 Participants
|
Adverse Events
Study Drug
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Drug
n=3 participants at risk
Ixazomib 4mg PO on days 1, 8, 15 Rituximab 375 mg/m2 IV weekly until cycle 3, then given day 1 of each cycle
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders- other, specify (COVID-19 pneumonia)
|
33.3%
1/3 • Number of events 1 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
33.3%
1/3 • Number of events 1 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
Nervous system disorders
Stroke
|
33.3%
1/3 • Number of events 1 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
Other adverse events
| Measure |
Study Drug
n=3 participants at risk
Ixazomib 4mg PO on days 1, 8, 15 Rituximab 375 mg/m2 IV weekly until cycle 3, then given day 1 of each cycle
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
Gastrointestinal disorders
Abdominal distention
|
33.3%
1/3 • Number of events 1 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
Renal and urinary disorders
Urinary tract infection
|
33.3%
1/3 • Number of events 1 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • Number of events 3 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
General disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
General disorders
Edema limbs
|
66.7%
2/3 • Number of events 2 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Number of events 1 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
General disorders
Nausea
|
33.3%
1/3 • Number of events 1 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Number of events 1 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
General disorders
Headache
|
33.3%
1/3 • Number of events 1 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
|
Nervous system disorders
Neuropathy
|
33.3%
1/3 • Number of events 1 • From first dose of study drug through 30 days after administration of the last dose of ixazomib, up to 140 weeks.
Adverse event data collected using definitions from CTCAE v4.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place