Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine Versus Idelalisib in Participants With Relapsed or Refractory Follicular Lymphoma (NCT NCT04699461)
NCT ID: NCT04699461
Last Updated: 2023-10-23
Results Overview
CRR was defined as the percentage of participants who experienced a best overall response (BOR) of complete response (CR) assessed prior to any subsequent anticancer treatment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Up to the end of treatment, maximum time on treatment was 333 days
Results posted on
2023-10-23
Participant Flow
Participant milestones
| Measure |
Loncastuximab Tesirine
Participants were administered loncastuximab tesirine as an intravenous (IV) infusion on Day 1 of each cycle, where 1 cycle is 3 weeks. Loncastuximab tesirine will be administered at a dose of 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles.
The median number of treatment cycles was 5.5 (min: 5; max: 12). The median treatment duration was 122.5 days (min: 54; max: 231 days).
|
Idelalisib
Participants were administered 150 mg idelalisib, orally, twice a day throughout each cycle, where 1 cycle is 4 weeks.
1 participant received 6 cycles and the other participant received 13 cycles of treatment. The treatment duration was 140 days and 333 days, respectively.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Loncastuximab Tesirine
Participants were administered loncastuximab tesirine as an intravenous (IV) infusion on Day 1 of each cycle, where 1 cycle is 3 weeks. Loncastuximab tesirine will be administered at a dose of 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles.
The median number of treatment cycles was 5.5 (min: 5; max: 12). The median treatment duration was 122.5 days (min: 54; max: 231 days).
|
Idelalisib
Participants were administered 150 mg idelalisib, orally, twice a day throughout each cycle, where 1 cycle is 4 weeks.
1 participant received 6 cycles and the other participant received 13 cycles of treatment. The treatment duration was 140 days and 333 days, respectively.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Study termination by sponsor
|
2
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Radiographic progression
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine Versus Idelalisib in Participants With Relapsed or Refractory Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Loncastuximab Tesirine
n=4 Participants
Participants were administered loncastuximab tesirine as an intravenous (IV) infusion on Day 1 of each cycle, where 1 cycle is 3 weeks. Loncastuximab tesirine was administered at a dose of 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles.
The median number of treatment cycles was 5.5 (min: 5; max: 12). The median treatment duration was 122.5 days (min: 54; max: 231 days).
|
Idelalisib
n=2 Participants
Participants were administered 150 mg idelalisib, orally, twice a day throughout each cycle, where 1 cycle is 4 weeks.
1 participant received 6 cycles and the other participant received 13 cycles of treatment. The treatment duration was 140 days and 333 days, respectively.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
55 to 69 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to the end of treatment, maximum time on treatment was 333 daysPopulation: No response data was collected.
CRR was defined as the percentage of participants who experienced a best overall response (BOR) of complete response (CR) assessed prior to any subsequent anticancer treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of treatment, maximum time on treatment was 333 daysPopulation: No response data was collected.
ORR was defined as the percentage of participants with a BOR of CR or partial response (PR) assessed prior to any subsequent anticancer treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of treatment, maximum time on treatment was 333 daysPopulation: Inclusive of participants who experienced recurrence, progression, or death.
PFS was defined as the time between the randomization date and the first documentation of recurrence, progression, or death.
Outcome measures
| Measure |
Loncastuximab Tesirine
n=1 Participants
Participants were administered loncastuximab tesirine as an intravenous (IV) infusion on Day 1 of each cycle, where 1 cycle is 3 weeks. Loncastuximab tesirine will be administered at a dose of 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles.
The median number of treatment cycles was 5.5 (min: 5; max: 12). The median treatment duration was 122.5 days (min: 54; max: 231 days).
|
Idelalisib
n=1 Participants
Participants were administered 150 mg idelalisib, orally, twice a day throughout each cycle, where 1 cycle is 4 weeks.
1 participant received 6 cycles and the other participant received 13 cycles of treatment. The treatment duration was 140 days and 333 days, respectively.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
NA days
Due to risk of re-identification.
|
NA days
Due to risk of re-identification.
|
SECONDARY outcome
Timeframe: Up to end of treatment, maximum time on treatment was 333 daysPopulation: Inclusive of participants who experienced death.
OS was defined as the time between the randomization date and death from any cause.
Outcome measures
| Measure |
Loncastuximab Tesirine
n=1 Participants
Participants were administered loncastuximab tesirine as an intravenous (IV) infusion on Day 1 of each cycle, where 1 cycle is 3 weeks. Loncastuximab tesirine will be administered at a dose of 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles.
The median number of treatment cycles was 5.5 (min: 5; max: 12). The median treatment duration was 122.5 days (min: 54; max: 231 days).
|
Idelalisib
Participants were administered 150 mg idelalisib, orally, twice a day throughout each cycle, where 1 cycle is 4 weeks.
1 participant received 6 cycles and the other participant received 13 cycles of treatment. The treatment duration was 140 days and 333 days, respectively.
|
|---|---|---|
|
Overall Survival (OS)
|
NA days
Due to risk of re-identification.
|
—
|
SECONDARY outcome
Timeframe: Up to end of treatment, maximum time on treatment was 333 daysPopulation: No response data was collected.
DOR was defined as the time from the documentation of tumor response to disease progression or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to 30 days after end of treatment, maximum time on treatment was 333 daysTEAEs were defined as an AE that occurs or worsens in the period extending from the first dose of study treatment until 30 days after the last dose of study treatment or start of new anti-cancer therapy, whichever is earlier. Any clinically significant changes from baseline in the safety laboratory values, vital signs, 12-lead electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status were reported as TEAEs.
Outcome measures
| Measure |
Loncastuximab Tesirine
n=4 Participants
Participants were administered loncastuximab tesirine as an intravenous (IV) infusion on Day 1 of each cycle, where 1 cycle is 3 weeks. Loncastuximab tesirine will be administered at a dose of 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles.
The median number of treatment cycles was 5.5 (min: 5; max: 12). The median treatment duration was 122.5 days (min: 54; max: 231 days).
|
Idelalisib
n=2 Participants
Participants were administered 150 mg idelalisib, orally, twice a day throughout each cycle, where 1 cycle is 4 weeks.
1 participant received 6 cycles and the other participant received 13 cycles of treatment. The treatment duration was 140 days and 333 days, respectively.
|
|---|---|---|
|
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
TEAEs
|
4 Participants
|
2 Participants
|
|
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
Serious TEAEs
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to end of treatment, maximum time on treatment was 333 daysPopulation: No data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of treatment, maximum time on treatment was 333 daysPopulation: No data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of treatment, maximum time on treatment was 333 daysPopulation: No data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of treatment, maximum time on treatment was 333 daysPopulation: No data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of treatment, maximum time on treatment was 333 daysPopulation: No data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of treatment, maximum time on treatment was 333 daysPopulation: No data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of treatment, maximum time on treatment was 333 daysPopulation: No data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of treatment, maximum time on treatment was 333 daysPopulation: No data was collected.
The specific symptomatic adverse events includes fatigue, swelling, rash, nausea, diarrhea, abdominal pain, and cough.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of treatment, maximum time on treatment was 333 daysPopulation: No data was collected.
The specific symptoms assessed include fatigue, swelling, rash, nausea, diarrhea, abdominal pain, and cough. The severity is assessed from "None" to "Very severe" and the interference level is assessed from "Not at all" to "Very much."
Outcome measures
Outcome data not reported
Adverse Events
Loncastuximab Tesirine
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Idelalisib
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Loncastuximab Tesirine
n=4 participants at risk
Participants were administered loncastuximab tesirine as an intravenous (IV) infusion on Day 1 of each cycle, where 1 cycle is 3 weeks. Loncastuximab tesirine will be administered at a dose of 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles.
The median number of treatment cycles was 5.5 (min: 5; max: 12). The median treatment duration was 122.5 days (min: 54; max: 231 days).
|
Idelalisib
n=2 participants at risk
Participants were administered 150 mg idelalisib, orally, twice a day throughout each cycle, where 1 cycle is 4 weeks.
1 participant received 6 cycles and the other participant received 13 cycles of treatment. The treatment duration was 140 days and 333 days, respectively.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Infections and infestations
COVID-19
|
50.0%
2/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Infections and infestations
COVID-19 pneumonia
|
50.0%
2/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
Other adverse events
| Measure |
Loncastuximab Tesirine
n=4 participants at risk
Participants were administered loncastuximab tesirine as an intravenous (IV) infusion on Day 1 of each cycle, where 1 cycle is 3 weeks. Loncastuximab tesirine will be administered at a dose of 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles.
The median number of treatment cycles was 5.5 (min: 5; max: 12). The median treatment duration was 122.5 days (min: 54; max: 231 days).
|
Idelalisib
n=2 participants at risk
Participants were administered 150 mg idelalisib, orally, twice a day throughout each cycle, where 1 cycle is 4 weeks.
1 participant received 6 cycles and the other participant received 13 cycles of treatment. The treatment duration was 140 days and 333 days, respectively.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
100.0%
2/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
100.0%
2/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Infections and infestations
COVID-19 infection
|
50.0%
2/4 • Up to end of treatment, maximum time on treatment was 333 days
|
50.0%
1/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
General disorders
Asthenia
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Investigations
Blood creatinine increased,
|
0.00%
0/4 • Up to end of treatment, maximum time on treatment was 333 days
|
50.0%
1/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
General disorders
Dysphagia,
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Hepatobiliary disorders
Porphyria non-acute
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Investigations
Lipase increased
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Investigations
Neutropenia
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Gastrointestinal disorders
Odynophagia
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Infections and infestations
Oral candidiasis
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Cardiac disorders
Pericardial effusion
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Skin and subcutaneous tissue disorders
Seborrheic keratosis
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Up to end of treatment, maximum time on treatment was 333 days
|
50.0%
1/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
General disorders
Malaise
|
25.0%
1/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
|
Infections and infestations
COVID-19 pneumonia
|
50.0%
2/4 • Up to end of treatment, maximum time on treatment was 333 days
|
0.00%
0/2 • Up to end of treatment, maximum time on treatment was 333 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place