Early Access Program With Inolimomab in Steroid-refractory Acute Graft Versus Host Disease

NCT05047328 | Unknown

• 1 other identifier: ATUC-LKT
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Leukotac (inolimomab) is not approved yet for marketing in any region. In the absence of medical options and based on the safety and efficacy data obtained during the clinical development program (in a phase III (INO-107) and in a Long Term Follow Up study), the French National Agency for the Medicines and Health Products Safety (ANSM) granted a Temporary Authorisation for Use (ATU) so-called cohort ATU (cATU) for LEUKOTAC® (inolimomab) and approved the temporary use protocol . This early access program has been granted to Leukotac (inolimomab) in adults and in children over 28 days of age, for treatment of acute cortico-resistant or cortico-dependent grades II-IV acute graft versus host disease (GvHD) according to the Glucksberg classification after allogeneic hematopoietic stem cell transplantation.

Conditions

Steroid Resistant Acute Graft Versus Host Disease

Interventions

inolimomab BIOLOGICAL

1 or 2 Induction Phases at 0.3 mg/kg/day for adults or 0.4 mg/kd/day for children over 8 consecutive days If no complete response (CR) occurs after 8 days, a second induction phase is conducted until day 16 (even if CR is obtained before completion of the second induction phase). Maintenance Phase: 0.4 mg/kg administered 3 times a week until Day 28 In case of a CR at day 9, the maintenance phase will start after day 9 and will be sustained until day 28. In case of a CR, partial response (PR) or mixed response (MR) at day 17, the maintenance phase will start after day 17 and will be sustained until day 28. Total duration of treatment is 28 ±2 days.

Also known as: Leukotac

Eligibility Criteria

• Age: 28 Days+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> or = 28 days
• Grade II-IV acute graft versus host disease according to Glucksberg classification after allogeneic hematopoietic stem cell transplantation
• Patients resistant or dependent to corticosteroid (CS)

You may not qualify if:

• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• ElsaLys Biotech: lead

Study Sites (1)

ElsaLys Biotech

Lyon, France

AVAILABLE

MeSH Terms

Interventions

inolimomab

Central Study Contacts

Raphaele Beaudet

CONTACT

+33 (0) 6 85 06 46 23; relationshospitalieres_RB@elsalysbiotech.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 17, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

FR (1)