Clinical trial NCT02999633: Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: T-cell Type Acute Leukemia-Precursor
T-lymphoblastic Lymphoma/Leukaemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-12-21
Enrollment: 14
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion criteria :

* Participants must had a known diagnosis of acute lymphoblastic leukemia (ALL) of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy.
* Participants must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Participants in first relapse were be eligible regardless of the first remission duration.
* Participants must had been previously exposed to nelarabine in countries where this drug is available (unless due to a contraindication to its use or administrative issue).
* No more than 3 prior salvage therapies.

Exclusion criteria:

* Prior treatment with immunotherapy/investigational agents within 3 weeks, chemotherapy within 2 weeks of study treatment. Must have recovered from acute toxicity before first study treatment administration.
* Prior stem cell transplant within 4 months and/or evidence of active systemic Graft versus Host Disease and/or immunosuppressive therapy for Graft versus Host Disease within 1 week before the first study treatment administration.
* Clinical evidence of active central nervous system (CNS) leukemia.
* T-ALL with testicular involvement alone.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: Percentage of Participants With Objective Response
timeFrame: Baseline until disease progression or death (maximum duration: 12.1 weeks)
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Baseline until disease progression or death (maximum duration: 12.1 weeks)
measure: Progression Free Survival (PFS)
timeFrame: Baseline until disease progression or death (maximum duration: 12.1 weeks)
measure: Overall Survival (OS)
timeFrame: Baseline until death (maximum duration: 12.1 weeks)
measure: Number of Participants With Minimal Residual Disease (MRD)
timeFrame: Baseline until death or study cut-off (maximum duration: 12.1 weeks)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Investigational Site Number 8400002
state: Georgia
city: Hackensack
country: United States
facility: Investigational Site Number 8400003
state: New Jersey
city: Houston
country: United States
facility: Investigational Site Number 8400001
state: Texas
city: Helsinki
country: Finland
facility: Investigational Site Number 2460001
city: Nantes Cedex 01
country: France
facility: Investigational Site Number 2500005
city: Paris Cedex 10
country: France
facility: Investigational Site Number 2500001
city: Pessac
country: France
facility: Investigational Site Number 2500004
city: Pierre Benite
country: France
facility: Investigational Site Number 2500002
city: Budapest
country: Hungary
facility: Investigational Site Number 3480001
city: Budapest
country: Hungary
facility: Investigational Site Number 3480003
city: Debrecen
country: Hungary
facility: Investigational Site Number 3480002
city: Bergamo
country: Italy
facility: Investigational Site Number 3800001
city: Brescia
country: Italy
facility: Investigational Site Number 3800004
city: Vilnius
country: Lithuania
facility: Investigational Site Number 4400001
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430003
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430004
city: Moscow
country: Russian Federation
facility: Investigational Site Number 6430001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Wang A, Song Z, Zheng G, Nicolazzi C, Fromm JR, Shehu E, Srinivasan S, Chen X, Zhu C, Blondel MC, Adrian FJ. Evaluation of Preclinical Activity of Isatuximab in Patients with Acute Lymphoblastic Leukemia. Mol Cancer Ther. 2021 Oct;20(10):1916-1925. doi: 10.1158/1535-7163.MCT-21-0058. Epub 2021 Aug 10.