NL-OMON48105
Completed
Phase 2
A Phase 1/2 open-label, multi-center, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab in combination with other anti-cancer therapies in participants with lymphoma - ACT15320
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- non-Hodgkin Peripheral T-cell lymfomen
- Sponsor
- Sanofi-aventis
- Enrollment
- 7
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Participants must be \>\= 18 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 (classic Hodgkin's lymphoma \[cHL]
- •anti\-programmed cell death protein 1/ligand 1 \[PD\-1/PD\-L1] inhibitor naïve):
- •Histologically confirmed advanced cHL that has relapsed or progressed after at
- •least 3 lines of systemic therapy that may include autologous hematopoietic
- •stem cell transplant (auto\-HSCT) or auto\-HSCT and brentuximab vedontin (BV), \-
- •For Cohort A2 (cHL anti\-PD\-1/PD\-L1inhibitor progressor): Histologically
- •confirmed advanced cHL which has relapsed or progressed after one previous
- •anti\-PD\-1/PD\-L1 containing regimen as the most recent prior therapy but no more
Exclusion Criteria
- •\-Prior exposure to agent that blocks CD38, \- For patients 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, CTLA\-4 or LAG\-3, \- Evidence of other
- •immune related disease /conditions, \- Has 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
Outcomes
Primary Outcomes
Not specified
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