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Clinical Sciences & Operations

Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group.

Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen.

Other Secondary Objectives : study of the neurotoxicity parameters (Duration of oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS)) ; study of the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free survival, overall survival).

Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.

A Multicenter, Randomized Double-blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Preventing the Neurotoxicity of Oxaliplatin in First-line Treatment of Patients With Metastatic Colorectal Cancer Treated With Oxaliplatin / 5-FU/LV

Sanofi

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Cytokine Release Syndrome

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Axicabtagene ciloleucel

Interleukin 1 Receptor Antagonist Protein

Antineoplastic Agents, Immunological

Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment.

* Screening
* Enrollment/Leukapheresis period
* Bridging therapy (if applicable)
* Lymphodepleting chemotherapy period
* Investigational Product (IP) treatment period

  * Anakinra
  * Axicabtagene Ciloleucel
* Post treatment assessment period
* Long term follow-up period

Subcutaneous, dosage per protocol. Day 0 through Day 6.

Anakinra

Once, intravenous infusion, dosage per protocol

Axicabtagene Ciloleucel

Matt J Frigault, MD

This research study is studying the combination of anakinra and axicabtagene ciloleucel to reduce the occurrence of the side effects Cytokine Release Syndrome (CRS) and neurologic toxicities with relapsed or refractory Non-Hodgkin lymphoma (NHL).

* Relapsed NHL is the condition of returned Non-Hodgkin lymphoma.
* Refractory NHL is the condition of previous treatment resistant Non-Hodgkin lymphoma.
* Cytokine Release Syndrome (CRS) is a group of side effect symptoms that can include nausea, headache, rapid heartbeat, shortness of breath, kidney damage, and rash.
* Neurologic toxicity is nervous system disorder characterized by confusion

This research study involves two drugs:

* Anakinra
* Axicabtagene Ciloleucel.

This Phase 2, single center, open-label research study is studying the combination of Anakinra and Axicabtagene Ciloleucel to reduce the occurrence of the side effects Cytokine Release Syndrome (CRS) and neurologic toxicities in people with relapsed or refractory Non-Hodgkin lymphoma (NHL).

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

* This research study involves two drugs:

  * Anakinra
  * Axicabtagene Ciloleucel
* A total of 20 participants will be enrolled to this trial
* The U.S. Food and Drug Administration (FDA) has not approved anakinra for use in treatment of Non-Hodgkin lymphoma (NHL).

A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The incidence of grade 2+ neurotoxicity will be assessed in comparison to a historical rate of 45% via a two-sized exact binomial test with significant level of 0.05.

The incidence of objective response and exact 2-sided 95% confidence intervals will be generated

Kaplan-Meier estimates and 2-sided 95% confidence intervals will be generated for progression-free survival time

Kaplan-Meier estimates and 2-sided 95% confidence intervals will be generated for OS.

Subject incidence rates of adverse events including all, serious, fatal, CTCAE version 4.03 Grade 3 or higher and treatment related AEs reported throughout the conduct of the study will be tabulated by preferred term and system organ class

Kite, A Gilead Company

Marcela V. Maus, M.D.,Ph.D.

Sponsor-Investigator

Neoplasms, Glandular and Epithelial

SR57746A

Gérard SAID, MD

Purpose of the trial is to evaluate the efficacy of Xaliproden in reducing the neurotoxicity of the Oxaliplatin and 5-FU/LV chemotherapy, in patients with metastatic colorectal carcinomaPrimary objectives : Compare the risk of occurence of grade 3-4 peripheral sensory neuropathy relative to the cumulative dose of Oxaliplatin between treatment group and placebo group ; Compare the response rate between treatment group and placebo group.Secondary objectives : neurotoxicity parameters (overall incidence, time and dose to onset, time to recovery, change in the sensory action potentials) ; antitumoral efficacy (progression-free survival, overall survival) ; safety profile.

XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy

A Multicenter Randomized Dble-Blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin and 5-FU/LV Combination in First-Line Treatment of Patients With Metastatic Colorectal Carcinoma(MCRC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.	NCT00305188	Metastases Colorectal Neop... Colorectal Carc...	Xaliproden (SR5... Placebo Oxaliplatin 5-Fluorouracil Leucovorin	18 Years -	Sanofi
A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity	NCT04150913	Non Hodgkin Lym... Refractory Non-... Relapsed Non Ho... Neurotoxicity Neurotoxicity S... Cytokine Releas...	Anakinra Axicabtagene Ci...	18 Years -	Massachusetts General Hospital
XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy	NCT00272051	Metastases Colorectal Neop... Colorectal Carc...	SR57746A	18 Years -	Sanofi

Spots Global Cancer Trial Database for neurotoxicity syndromes