Trial Outcomes & Findings for Leflunomide for the Treatment of Relapsed or Refractory CD30+ Lymphoproliferative Disorders (NCT NCT04463615)
NCT ID: NCT04463615
Last Updated: 2023-12-05
Results Overview
Defined as the proportion of patients with a documented response (complete response \[CR\] or partial \[PR\]) any time during study treatment. Response will be categorized by modified severity weighted assessment tool (mSWAT). Will be calculated along with the Clopper Pearson binomial 95% exact confidence intervals. The treatment response was assessed after each 28-day cycle treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and then was off treatment on Day 14 of the second cycle due to disease progression.
Results posted on
2023-12-05
Participant Flow
Participant milestones
| Measure |
Treatment (Leflunomide)
Patients receive leflunomide PO QD on days 1-28. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.
Leflunomide: Given PO
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Leflunomide for the Treatment of Relapsed or Refractory CD30+ Lymphoproliferative Disorders
Baseline characteristics by cohort
| Measure |
Treatment (Leflunomide)
n=1 Participants
Patients receive leflunomide PO QD on days 1-28. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.
Leflunomide: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 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
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and then was off treatment on Day 14 of the second cycle due to disease progression.Defined as the proportion of patients with a documented response (complete response \[CR\] or partial \[PR\]) any time during study treatment. Response will be categorized by modified severity weighted assessment tool (mSWAT). Will be calculated along with the Clopper Pearson binomial 95% exact confidence intervals. The treatment response was assessed after each 28-day cycle treatment.
Outcome measures
| Measure |
Treatment (Leflunomide)
n=1 Participants
Patients receive leflunomide PO QD on days 1-28. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.
Leflunomide: Given PO
|
|---|---|
|
Overall Response Rate
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and was off treatment on Day 14 of the second cycle due to disease progression.Defined as the proportion of patients with a documented CR any time during study treatment. Response will be assessed by mSWAT. Will be calculated along with the Clopper Pearson binomial 95% exact confidence intervals. The treatment response was assessed after each 28-day cycle treatment.
Outcome measures
| Measure |
Treatment (Leflunomide)
n=1 Participants
Patients receive leflunomide PO QD on days 1-28. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.
Leflunomide: Given PO
|
|---|---|
|
Complete Response Rate
|
0 percentage of participants
|
Adverse Events
Treatment (Leflunomide)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Leflunomide)
n=1 participants at risk
Patients receive leflunomide PO QD on days 1-28. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.
Leflunomide: Given PO
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and then was off treatment on Day 14 of the second cycle due to disease progression. The adverse effects were monitored and assessed at each cycle treatment. All-cause mortality monitored/assessed up to 84 days from the start time of the initial study treatment.
|
|
Investigations
Cholesterol high
|
100.0%
1/1 • Number of events 1 • Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and then was off treatment on Day 14 of the second cycle due to disease progression. The adverse effects were monitored and assessed at each cycle treatment. All-cause mortality monitored/assessed up to 84 days from the start time of the initial study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
100.0%
1/1 • Number of events 1 • Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and then was off treatment on Day 14 of the second cycle due to disease progression. The adverse effects were monitored and assessed at each cycle treatment. All-cause mortality monitored/assessed up to 84 days from the start time of the initial study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
1/1 • Number of events 2 • Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and then was off treatment on Day 14 of the second cycle due to disease progression. The adverse effects were monitored and assessed at each cycle treatment. All-cause mortality monitored/assessed up to 84 days from the start time of the initial study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
100.0%
1/1 • Number of events 1 • Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and then was off treatment on Day 14 of the second cycle due to disease progression. The adverse effects were monitored and assessed at each cycle treatment. All-cause mortality monitored/assessed up to 84 days from the start time of the initial study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
100.0%
1/1 • Number of events 1 • Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and then was off treatment on Day 14 of the second cycle due to disease progression. The adverse effects were monitored and assessed at each cycle treatment. All-cause mortality monitored/assessed up to 84 days from the start time of the initial study treatment.
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Number of events 1 • Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and then was off treatment on Day 14 of the second cycle due to disease progression. The adverse effects were monitored and assessed at each cycle treatment. All-cause mortality monitored/assessed up to 84 days from the start time of the initial study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
100.0%
1/1 • Number of events 1 • Up to 42 days from the start time of the initial study treatment. Patient received one 28-day cycle treatment and then was off treatment on Day 14 of the second cycle due to disease progression. The adverse effects were monitored and assessed at each cycle treatment. All-cause mortality monitored/assessed up to 84 days from the start time of the initial study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place