Trial Outcomes & Findings for Dimethylfumarate (DMF) in Relapsed/Refractory CLL/SLL (NCT NCT02784834)
NCT ID: NCT02784834
Last Updated: 2019-09-19
Results Overview
The incidence of dose limiting toxicities (DLTs) will be used to define the maximum tolerated dose or biologically active dose for potential phase 2 studies.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
2 participants
Primary outcome timeframe
2 months
Results posted on
2019-09-19
Participant Flow
Participant milestones
| Measure |
Dimethyl Fumarate (DMF)
Cohort 1: dimethyl fumarate 120 mg PO BID (approximately 12 hours apart) for 2 x 28 day cycles.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Dimethyl Fumarate (DMF)
Cohort 1: dimethyl fumarate 120 mg PO BID (approximately 12 hours apart) for 2 x 28 day cycles.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Dimethylfumarate (DMF) in Relapsed/Refractory CLL/SLL
Baseline characteristics by cohort
| Measure |
Dimethyl Fumarate (DMF)
n=2 Participants
Cohort 1: dimethyl fumarate 120 mg PO BID (approximately 12 hours apart) for 2 x 28 day cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 monthsThe incidence of dose limiting toxicities (DLTs) will be used to define the maximum tolerated dose or biologically active dose for potential phase 2 studies.
Outcome measures
| Measure |
Dimethyl Fumarate (DMF)
n=2 Participants
Cohort 1: dimethyl fumarate 120 mg PO BID (approximately 12 hours apart) for 2 x 28 day cycles.
|
|---|---|
|
Incidence of Dose Limiting Toxicity
|
0 Participants
|
Adverse Events
Dimethyl Fumarate (DMF)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dimethyl Fumarate (DMF)
n=2 participants at risk
Cohort 1: dimethyl fumarate 120 mg PO BID (approximately 12 hours apart) for 2 x 28 day cycles.
|
|---|---|
|
Immune system disorders
Allergic Reaction
|
50.0%
1/2 • Number of events 1 • 4 months
|
|
Blood and lymphatic system disorders
Lymph node pain
|
50.0%
1/2 • Number of events 1 • 4 months
|
|
Vascular disorders
Flushing
|
100.0%
2/2 • Number of events 2 • 4 months
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • 4 months
|
|
Investigations
Thrombocytopenia
|
100.0%
2/2 • Number of events 2 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place