Trial Outcomes & Findings for Enzalutamide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma (NCT NCT02489123)
NCT ID: NCT02489123
Last Updated: 2021-08-10
Results Overview
An ORR of 20% (4 or more responses among 20 patients) will be taken as a benchmark for success for the primary endpoint of this pilot study. Evaluation of response is per standard NCI Response Criteria Cheson 2014 and assessed by PET-CT; CR = complete metabolic response, PR = decrease by more the 50% in the sum of the product of the perpendicular diameters.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2021-08-10
Participant Flow
Participant milestones
| Measure |
Treatment (Enzalutamide)
Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enzalutamide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Enzalutamide)
n=8 Participants
Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
60 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsAn ORR of 20% (4 or more responses among 20 patients) will be taken as a benchmark for success for the primary endpoint of this pilot study. Evaluation of response is per standard NCI Response Criteria Cheson 2014 and assessed by PET-CT; CR = complete metabolic response, PR = decrease by more the 50% in the sum of the product of the perpendicular diameters.
Outcome measures
| Measure |
Treatment (Enzalutamide)
n=7 Participants
Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Best Overall Response Rate (ORR) Including Complete Response (CR) and Partial Response (PR) as Measured by Standard Criteria
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first treatment administration to the first time to treatment failure, assessed up to 5 yearsOutcome measures
| Measure |
Treatment (Enzalutamide)
n=8 Participants
Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Time to Treatment Failure
|
14 Weeks
Interval 10.0 to 35.0
|
SECONDARY outcome
Timeframe: From first study drug administration to the first occurrence of disease progression or death from any cause, assessed up to 5 yearsKaplan-Meier methodology will be used to estimate event-free curves and corresponding quartiles (including the median).
Outcome measures
| Measure |
Treatment (Enzalutamide)
n=8 Participants
Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Progression-free Survival
|
4.1 Months
Interval 1.3 to 8.3
|
SECONDARY outcome
Timeframe: Up to 5 yearsOutcome measures
| Measure |
Treatment (Enzalutamide)
n=8 Participants
Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Survival
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after study treatment completion, an average of 18 weeks.Outcome measures
| Measure |
Treatment (Enzalutamide)
n=8 Participants
Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Number of Participants With One or More Adverse Events, Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe count of participants who achieved a CR, PR, or SD for greater than 3 months.
Outcome measures
| Measure |
Treatment (Enzalutamide)
n=8 Participants
Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Disease Control Rate (CR + PR + Stable Disease [SD] > 3 Months)
|
4 Participants
|
Adverse Events
Treatment (Enzalutamide)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment (Enzalutamide)
n=8 participants at risk
Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Triple Arthrodesis Right Ankle Surgery
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
Other adverse events
| Measure |
Treatment (Enzalutamide)
n=8 participants at risk
Patients receive enzalutamide PO QD. Courses 1-3 repeat every 4 weeks (28 days) and subsequent courses repeat every 12 weeks (84 days) in the absence of disease progression or unacceptable toxicity.
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
2/8 • Number of events 2 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Psychiatric disorders
Agitation
|
25.0%
2/8 • Number of events 3 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Renal and urinary disorders
Decreased Urination
|
25.0%
2/8 • Number of events 2 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Reproductive system and breast disorders
Breast Tenderness
|
25.0%
2/8 • Number of events 2 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Vascular disorders
Hot Flashes
|
62.5%
5/8 • Number of events 6 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Investigations
Platelet Count Decreased
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
General disorders
Fatigue
|
62.5%
5/8 • Number of events 5 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.5%
3/8 • Number of events 3 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
25.0%
2/8 • Number of events 4 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
2/8 • Number of events 2 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
General disorders
Ankle Pain
|
12.5%
1/8 • Number of events 3 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Reproductive system and breast disorders
Decrease in genital size
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
General disorders
Genital oder
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin Changes
|
37.5%
3/8 • Number of events 3 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
General disorders
Non-cardiac chest pain
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Gastrointestinal disorders
Dry Mouth
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Eye disorders
Eye Pain
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Blood and lymphatic system disorders
Increased white blood cell count
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Skin and subcutaneous tissue disorders
Paresthesia
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
12.5%
1/8 • Number of events 1 • Adverse Events of Grade 3 and above will be monitored and recorded from the time of the first dose of study treatment through 30 days following the end of study treatment, an average of 18 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place