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
- Conditions
- non-Hodgkin Peripheral T-cell lymfomenHodgkin and non-Hodgkin lymphomaleukemia1002531910025320
- Registration Number
- NL-OMON48105
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
- 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
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 (IMP), - For Cohort B (diffuse large B-cell lymphoma
[DLBCL]):Histologically confirmed advanced DLBCL that has relapsed or
progressed after 2 lines of systemic therapy including auto-HSCT or 2 lines of
systemic therapy for participants who are not eligible for auto-HSCT, - For
Cohort C (peripheral T-cell lymphoma [PTCL]): Histologically confirmed advanced
PTCL that has relapsed or progressed after either first-line chemotherapy and
auto-HSCT as consolidation of first remission or first-line chemotherapy if
participants are ineligible for auto-HSCT, - Body weight of > 45 kg
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method