Trial Outcomes & Findings for Study of MLN9708 as Maintenance Therapy for Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) in Remission (NCT NCT02302846)
NCT ID: NCT02302846
Last Updated: 2018-10-03
Results Overview
RFS defined as interval from date of enrollment to date of first objective documentation of disease relapse or death from any cause. Survival or times to failure and time to progression functions estimated using Kaplan-Meier method.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
84 days
Results posted on
2018-10-03
Participant Flow
Recruitment Period: May 2015 through March 2016. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.
Of the five participants enrolled in this study, three were evaluable for response. One participant was evaluable for toxicity. A fifty participant was registered but did not receive therapy due to the patient's decision to continue a prior therapy.
Participant milestones
| Measure |
Ixazomib
Participants receive 4 mg oral dose of Ixazomib on Days 1, 8 and 15 of each 28-day cycle.
Ixazomib: 4 mg by mouth on Days 1, 8 and 15 of each 28-day cycle.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Ixazomib
Participants receive 4 mg oral dose of Ixazomib on Days 1, 8 and 15 of each 28-day cycle.
Ixazomib: 4 mg by mouth on Days 1, 8 and 15 of each 28-day cycle.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study of MLN9708 as Maintenance Therapy for Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) in Remission
Baseline characteristics by cohort
| Measure |
Ixazomib
n=5 Participants
Participants receive 4 mg oral dose of Ixazomib on Days 1, 8 and 15 of each 28-day cycle.
Ixazomib: 4 mg by mouth on Days 1, 8 and 15 of each 28-day cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 84 daysPopulation: Three participants were evaluable for response. One patient was evaluable for toxicity only. No other analysis is possible due to the low number of patients accrued.
RFS defined as interval from date of enrollment to date of first objective documentation of disease relapse or death from any cause. Survival or times to failure and time to progression functions estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Ixazomib
n=3 Participants
Participants receive 4 mg oral dose of Ixazomib on Days 1, 8 and 15 of each 28-day cycle.
Ixazomib: 4 mg by mouth on Days 1, 8 and 15 of each 28-day cycle.
|
|---|---|
|
Relapse-Free Survival (RFS)
|
34 Weeks
Interval 19.0 to 50.0
|
Adverse Events
Ixazomib
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixazomib
n=4 participants at risk
Participants receive 4 mg oral dose of Ixazomib on Days 1, 8 and 15 of each 28-day cycle.
Ixazomib: 4 mg by mouth on Days 1, 8 and 15 of each 28-day cycle.
|
|---|---|
|
General disorders
Fall
|
25.0%
1/4 • Number of events 1 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Number of events 1 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
1/4 • Number of events 1 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
Other adverse events
| Measure |
Ixazomib
n=4 participants at risk
Participants receive 4 mg oral dose of Ixazomib on Days 1, 8 and 15 of each 28-day cycle.
Ixazomib: 4 mg by mouth on Days 1, 8 and 15 of each 28-day cycle.
|
|---|---|
|
General disorders
Intermittent Headache
|
25.0%
1/4 • Number of events 1 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
2/4 • Number of events 3 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 2 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 2 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
|
Infections and infestations
Sinusitis
|
25.0%
1/4 • Number of events 1 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
25.0%
1/4 • Number of events 1 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
|
Blood and lymphatic system disorders
Decreased White Blood Count
|
25.0%
1/4 • Number of events 1 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
|
Infections and infestations
Neutropenia
|
25.0%
1/4 • Number of events 1 • Adverse events reported during each treatment course, an average of one year . Overall period: May 2015 to March 2016.
|
Additional Information
Courtney DiNardo, MD/Assistant Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-794-1141
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place