Status:
TERMINATED
A Study of Isatuximab-based Therapy in Participants With Lymphoma
Lead Sponsor:
Sanofi
Conditions:
Lymphoma
Eligibility:
All Genders
12+ years
Phase:
PHASE1
PHASE2
Brief Summary
Primary Objectives: Phase 1 -To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory classic Hodgkin's lymphoma (cHL), d...
Detailed Description
The total study duration per participant was up to 28 months, including an up to 28-day screening period, an up to 96-week treatment period, and a 90-day safety follow up period.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Participants greater than or equal to (\>=) 12 years of age inclusive, at the time of signing the informed consent.
- Disease location amenable to tumor biopsy at Baseline.
- Measurable disease.
- For Cohort A1 (cHL anti-programmed cell death protein 1/ligand 1 \[PD-1/PD-L1\] inhibitor naïve): Histologically confirmed advanced cHL that had relapsed or progressed after at least 3 lines of systemic therapy that included autologous hematopoietic stem cell transplant (auto-HSCT) or auto-HSCT and brentuximab vedotin (BV).
- For Cohort A2 (cHL anti-PD-1/PD-L1 inhibitor progressor): Histologically confirmed advanced cHL which had relapsed or progressed after one previous anti-PD-1/PD-L1 containing regimen as the most recent prior therapy but no more than 4 lines of previous chemotherapy including the anti-PD-1/PD-L1 containing regimen and documentation of benefit during or after the anti-PD-1/PD-L1 containing regimen within 4 months prior to initiation of investigational medicinal product.
- For Cohort B (diffuse large B-cell lymphoma \[DLBCL\]): Histologically confirmed advanced DLBCL that had relapsed or progressed after 2 lines of systemic therapy including auto-HSCT or 2 lines of systemic therapy for participants who were not eligible for auto-HSCT.
- For Cohort C (peripheral T-cell lymphoma \[PTCL\]): Histologically confirmed advanced PTCL that had relapsed or progressed after either first-line chemotherapy and auto-HSCT as consolidation of first remission or first-line chemotherapy if participants were ineligible for auto-HSCT.
- Body weight of greater than (\>) 45 kilograms for participants with age less than (\<)18 years.
- Exclusion criteria:
- Prior exposure to agent that blocks CD38.
- For participants with cHL (PD-1/PD-L1 naïve), DLBCL or PTCL prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1, PD-L2, CD137, cytotic T-lymphocyte-associated protein 4 or LAG-3.
- Evidence of other immune related disease/conditions.
- Had received a live-virus vaccination within 28 days of planned treatment start; seasonal flu vaccines that do not contain live virus are permitted.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) \>=2.
- Poor bone marrow reserve.
- Poor organ function.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
December 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2022
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03769181
Start Date
December 11 2018
End Date
November 8 2022
Last Update
September 23 2025
Active Locations (20)
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1
Investigational Site Number :2500005
Dijon, France, 21000
2
Investigational Site Number :2500004
Montpellier, France, 34295
3
Investigational Site Number :2500002
Nantes, France, 44093
4
Investigational Site Number :2500007
Pessac, France, 33600