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Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia (ISLAY)

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ClinicalTrials.gov Identifier: NCT02999633
Recruitment Status : Terminated (Due to an unsatisfactory benefit/risk ratio, as specified in & 14.8.1 of the protocol, Sanofi decided to stop enrollment and terminate ACT14596 prematurely)
First Posted : December 21, 2016
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

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 patients with T-ALL or T-LBL.
  • To evaluate immunogenicity of isatuximab in patients with T-ALL or T-LBL.
  • To assess minimal residual disease (MRD) and correlate it with clinical outcome.

Condition or disease Intervention/treatment Phase
T-cell Type Acute Leukemia-Precursor T-lymphoblastic Lymphoma/Leukaemia Drug: Isatuximab SAR650984 Drug: dexamethasone Drug: acetaminophen Drug: ranitidine Drug: diphenhydramine Phase 2

Detailed Description:
The study duration per patient will include 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 8, 2017
Actual Primary Completion Date : November 14, 2017
Actual Study Completion Date : November 14, 2017


Arm Intervention/treatment
Experimental: Isatuximab
Isatuximab administration every week for 4 or 8 weeks (Induction), followed by administration every 2 weeks (Maintenance). Dexamethasone, acetaminophen, ranitidine, and diphenhydramine will be administered as premedications. - Type: Experimental
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




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) ]

Secondary Outcome Measures :
  1. Duration of response - time [ Time Frame: 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) ]
  2. Progression free survival - time [ Time Frame: 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) ]
  3. Overall survival - time [ Time Frame: 6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Patients must have a known diagnosis of ALL of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy.
  • Patients must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Patients in first relapse will be eligible regardless of the first remission duration.
  • Patients must have 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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999633


Locations
United States, Georgia
Investigational Site Number 8400002
Atlanta, Georgia, United States, 30342
United States, New Jersey
Investigational Site Number 8400003
Hackensack, New Jersey, United States, 07601
United States, Texas
Investigational Site Number 8400001
Houston, Texas, United States, 77030
Finland
Investigational Site Number 2460001
Helsinki, Finland, 00029
France
Investigational Site Number 2500005
Nantes Cedex 01, France, 44093
Investigational Site Number 2500001
Paris Cedex 10, France, 75475
Investigational Site Number 2500004
Pessac, France, 33600
Investigational Site Number 2500002
Pierre Benite, France, 69310
Hungary
Investigational Site Number 3480001
Budapest, Hungary, 1083
Investigational Site Number 3480003
Budapest, Hungary, 1097
Investigational Site Number 3480002
Debrecen, Hungary, 4032
Italy
Investigational Site Number 3800001
Bergamo, Italy, 24127
Investigational Site Number 3800004
Brescia, Italy, 25123
Lithuania
Investigational Site Number 4400001
Vilnius, Lithuania, 08661
Russian Federation
Investigational Site Number 6430003
Moscow, Russian Federation, 117198
Investigational Site Number 6430004
Moscow, Russian Federation, 125167
Investigational Site Number 6430001
Moscow, Russian Federation, 129301
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02999633     History of Changes
Other Study ID Numbers: ACT14596
2016‐002739‐14 ( EudraCT Number )
U1111-1179-5294 ( Other Identifier: UTN )
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Diphenhydramine
Ranitidine bismuth citrate
Ranitidine
Acetaminophen
BB 1101
Promethazine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal