Trials / Terminated
TerminatedNCT02999633
Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients With Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To evaluate the efficacy of isatuximab. Secondary Objectives: * To evaluate the safety profile of isatuximab. * To evaluate the duration of response (DOR). * To evaluate progression free survival (PFS) and overall survival (OS). * To evaluate the pharmacokinetics (PK) of isatuximab in participants with T-ALL or T-LBL. * To evaluate immunogenicity of isatuximab in participants with T-ALL or T-LBL. * To assess minimal residual disease (MRD) and correlate it with clinical outcome.
Detailed description
The study duration per participant included a 3-week screening period, an approximately 1 year of treatment period or until disease progression or discontinuation for any other reason, and a follow-up period of at least 30 days after the last investigational medicinal product administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Isatuximab SAR650984 | Pharmaceutical form:solution Route of administration: intravenous |
| DRUG | dexamethasone | Pharmaceutical form:pills Route of administration: oral |
| DRUG | dexamethasone | Pharmaceutical form:solution Route of administration: intravenous |
| DRUG | acetaminophen | Pharmaceutical form:pills Route of administration: oral |
| DRUG | ranitidine | Pharmaceutical form:solution Route of administration: intravenous |
| DRUG | diphenhydramine | Pharmaceutical form:solution Route of administration: intravenous |
Timeline
- Start date
- 2017-03-08
- Primary completion
- 2017-11-14
- Completion
- 2017-11-14
- First posted
- 2016-12-21
- Last updated
- 2022-03-21
- Results posted
- 2020-01-18
Locations
17 sites across 7 countries: United States, Finland, France, Hungary, Italy, Lithuania, Russia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02999633. Inclusion in this directory is not an endorsement.