Safety and Antitumor Activity Study of Loncastuximab Tesirine and Durvalumab in Diffuse Large B-Cell, Mantle Cell, or Follicular Lymphoma
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|ClinicalTrials.gov Identifier: NCT03685344|
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : December 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-Cell Lymphoma Mantle Cell Lymphoma Follicular Lymphoma||Drug: Loncastuximab Tesirine and Durvalumab||Phase 1|
This is a Phase 1b, open-label, single-arm combination study with a dose escalation phase (Part 1) followed by a dose expansion phase (Part 2). The study will enroll approximately 75 patients.
A standard 3+3 dose escalation design will be used for Part 1. The DLT period will be the 21 days after the first durvalumab dose.
Part 2 will consist of up to 3 expansion cohorts, one for DLBCL, one for MCL, and one for FL. Each cohort will be approximately 20 patients treated at the dose determined in Part 1.
The study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 3, 6' and 4 weeks), and a Follow-up Period (approximately every 12 week visits for up to 2 years after treatment discontinuation).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Open-Label Study to Evaluate the Safety and Antitumor Activity of Loncastuximab Tesirine and Durvalumab in Patients With Advanced Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma|
|Estimated Study Start Date :||December 6, 2018|
|Estimated Primary Completion Date :||July 8, 2020|
|Estimated Study Completion Date :||July 6, 2022|
A standard 3+3 dose escalation design will be used for Part 1. The DLT period will be the 21 days after the first durvalumab dose. Part 2 will consist of up to 3 expansion cohorts, one for DLBCL, one for MCL, and one for FL. Each cohort will be approximately 20 patients treated at the dose determined in Part 1.
Drug: Loncastuximab Tesirine and Durvalumab
Other Name: ADCT-402 in combination with Durvalumab
- Safety and tolerability of loncastuximab tesirine in combination with durvalumab by frequency and severity of adverse events [ Time Frame: Until 30 days after last dose ]Frequency and severity of adverse events (AEs)
- Frequency and severity of serious adverse events (SAEs) [ Time Frame: Until 30 days after last dose ]
- Incidence of dose limiting toxicities (DLTs) (dose escalation only) [ Time Frame: First 21-day cycle for each patient (dose escalation only) ]
- Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]ORR according to the 2014 Lugano classification, defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR)
- Complete Response Rate CR [ Time Frame: Up to 2 years ]Complete response rate defined as the percentage of treated patients with a BOR of CR
- Duration of response (time from first tumor response to disease progression or death) [ Time Frame: Up to 2 years ]
- Overall survival (time between the start of treatment and death from any cause) [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685344
|Contact: ADC Therapeuticsemail@example.com|
|United States, Texas|
|Baylor Scott & White Medical Center - Temple||Recruiting|
|Temple, Texas, United States, 76508|
|Contact: Vinit G Kanur, MD|