This study aims to evaluate the efficacy of single agent loncastuximab tesirine compared to idelalisib in participants with relapsed or refractory follicular lymphoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
IV infusion
Oral tablet
Complete Response Rate (CRR)
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.
Time frame: Up to the end of treatment, maximum time on treatment was 333 days
Overall Response Rate (ORR)
ORR was defined as the percentage of participants with a BOR of CR or partial response (PR) assessed prior to any subsequent anticancer treatment.
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Progression-Free Survival (PFS)
PFS was defined as the time between the randomization date and the first documentation of recurrence, progression, or death.
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Overall Survival (OS)
OS was defined as the time between the randomization date and death from any cause.
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Duration of Response (DOR)
DOR was defined as the time from the documentation of tumor response to disease progression or death.
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
TEAEs 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.
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Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Summit Medical Group - Florham Park Campus
Florham Park, New Jersey, United States
Summit Medical Group
Florham Park, New Jersey, United States
Hollings Cancer Center
Charleston, South Carolina, United States
Universitair Ziekenhuis Gent
Ghent, Belgium
Centre Hospitalier Universitaire Universite Catholique de Louvain
Yvoir, Belgium
Centre Hospitalier de Dunkerque
Dunkirk, France
Centre Hospitalier de La Rochelle
La Rochelle, France
Centre de Lutte Contre le Cancer - Centre Henri-Becquerel
Rouen, France
...and 24 more locations
Time frame: Day 1 to 30 days after end of treatment, maximum time on treatment was 333 days
Average Concentration of Loncastuximab Tesirine Before Infusion
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Average Concentration of Loncastuximab Tesirine at the End of Infusion
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Clearance Rate of Loncastuximab Tesirine
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Volume of Distribution of Loncastuximab Tesirine
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Number of Participants With Specific Symptomatic Adverse Event Symptoms As Selected From Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
The specific symptomatic adverse events includes fatigue, swelling, rash, nausea, diarrhea, abdominal pain, and cough.
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Treatment-Related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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."
Time frame: Up to end of treatment, maximum time on treatment was 333 days