Steroid Refractory GVHDPhase 3EiFFELNCT04289103
Evaluation of EFficacy and SaFEty of Leukotac (Inolimomab) in Pediatric Patients With SR-aGvHD
A Phase 3 study testing Inolimomab (Leukotac) in people with Steroid Refractory GVHD, run by ElsaLys Biotech.
Trial summary
A Phase 3, Multicenter, open label, study to Evaluate the EFficacy and SaFEty of Leukotac® (inolimomab) in pediatric patients with steroid resistant acute Graft versus Host Disease (SR-aGvHD) Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Steroid Refractory GVHD
- What is being tested?
- Inolimomab (Leukotac)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who develop a first episode of aGvHD stage ≥ II (Przepiorka et al., 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone equivalent dose)
- Age 28 days to < 18 years old
- Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
- Patients receiving Allo-HSCT for any indication (i.e. malignant or non-malignant disease)
- Signature of informed and written consent by the patient and/or by the patient's legally acceptable representative(s)
Who cannot join
- Isolated stage 1 skin SR-aGvHD
- Overlap chronic GvHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
- Acute GvHD after donor lymphocytes infusion (DLI)
- Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
- Other systemic drugs than corticosteroids for GvHD treatment (including extra-corporeal photopheresis). Drugs already being used for GvHD prevention (e.g. calcineurin inhibitors) are allowed.
- Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
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- Known allergy or intolerance to Leukotac of one of its ingredients
- Pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female and male of childbearing potential
- Other ongoing interventional protocol that might interfere with
About this study
Official title: A Phase 3, Multicenter, Open Label, Study to Evaluate the EFficacy and SaFEty of Leukotac® (Inolimomab) in Pediatric Patients With Steroid Resistant Acute Graft Versus Host Disease (SR-aGvHD)
A Phase 3, Multicenter, open label, study to Evaluate the EFficacy and SaFEty of Leukotac® (inolimomab) in pediatric patients with steroid resistant acute Graft versus Host Disease (SR-aGvHD)
- Conditions
- Steroid Refractory GVHD
- Being tested
- Inolimomab (Leukotac)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inolimomab (Leukotac)Biological
- Patient screening phase - Patients diagnosed with aGvHD will be identified. Only patients with SR-aGvHD will be finally included in the study.
- Treatment phase - Leukotac will be given up to D28
- Primary Follow-up phase - Patient's response (CR and PR) will be evaluated at D29 post inclusion. Patients will then be followed for survival, long-term safety and chronic GvHD occurrence during 6 months after inclusion.
| Study group | Role | What they receive |
|---|---|---|
| Inolimomab/Leukotac | Experimental | * Patient screening phase - Patients diagnosed with aGvHD will be identified. Only patients with SR-aGvHD will be finally included in the study.
* Treatment phase - Leukotac will be given up to D28
* Primary Follow-up phase - Patient's response (CR and PR) will be evaluated at D29 post inclusion. Patients will then be followed for survival, long-term safety and chronic GvHD occurrence during 6 months after inclusion Receives: Biological: Inolimomab (Leukotac) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response
Complete response + very good partial response + partial response
Measured: Day 29 post inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study startOct 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steroid Refractory GVHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ElsaLys Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289103
- Sponsor's protocol ID
- INO-108
- Acronym
- EiFFEL
- Status last verified
- Dec 2020
- First submitted
- 25 Feb 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open Label, Study to Evaluate the EFficacy and SaFEty of Leukotac® (Inolimomab) in Pediatric Patients With Steroid Resistant Acute Graft Versus Host Disease (SR-aGvHD)
- ClinicalTrials.gov ID
- NCT04289103
- Acronym / sponsor ID
- EiFFEL / INO-108
- Conditions
- Steroid Refractory GVHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- ElsaLys BiotechIndustry (pharma, biotech, devices)
- Study start
- Oct 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 3, Multicenter, open label, study to Evaluate the EFficacy and SaFEty of Leukotac® (inolimomab) in pediatric patients with steroid resistant acute Graft versus Host Disease (SR-aGvHD)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inolimomab/Leukotac | Experimental | Biological: Inolimomab (Leukotac)* Patient screening phase - Patients diagnosed with aGvHD will be identified. Only patients with SR-aGvHD will be finally included in the study. * Treatment phase - Leukotac will be given up to D28 * Primary Follow-up phase - Patient's response (CR and PR) will be evaluated at D29 post inclusion. Patients will then be followed for survival, long-term safety and chronic GvHD occurrence during 6 months after inclusion |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients who develop a first episode of aGvHD stage ≥ II (Przepiorka et al., 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone equivalent dose)
- Age 28 days to < 18 years old
- Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
- Patients receiving Allo-HSCT for any indication (i.e. malignant or non-malignant disease)
- Signature of informed and written consent by the patient and/or by the patient's legally acceptable representative(s)
Key exclusion criteria (9 listed)
- Isolated stage 1 skin SR-aGvHD
- Overlap chronic GvHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
- Acute GvHD after donor lymphocytes infusion (DLI)
- Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
- Other systemic drugs than corticosteroids for GvHD treatment (including extra-corporeal photopheresis). Drugs already being used for GvHD prevention (e.g. calcineurin inhibitors) are allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inolimomab (Leukotac)* Patient screening phase - Patients diagnosed with aGvHD will be identified. Only patients with SR-aGvHD will be finally included in the study. * Treatment phase - Leukotac will be given up to D28 * Primary Follow-up phase - Patient's response (CR and PR) will be evaluated at D29 post inclusion. Patients will then be followed for survival, long-term safety and chronic GvHD occurrence during 6 months after inclusion. | Biological | Inolimomab/Leukotac |
Primary outcome
Overall response
Time frame: Day 29 post inclusion
Complete response + very good partial response + partial response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inolimomab (Leukotac) in people with Steroid Refractory GVHD, run by ElsaLys Biotech.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response (time frame: Day 29 post inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.