MedTrace Logo

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

NCT05047328 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2021-09-17

No results posted yet for this study

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

BIOLOGICAL

inolimomab

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.

Sponsors & Collaborators

  • ElsaLys Biotech

    lead INDUSTRY

Eligibility

Min Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05047328 on ClinicalTrials.gov