Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation Among Children With Hematologic Malignancies
Recruiting
Phase 2
Phase 3
Interventional Study
Acute Myeloid Leukemia, Relapsed
Acute Lymphoblastic Leukemia, High Risk
Acute Myeloid Leukemia, High Risk
Acute Lymphoblastic Leukemia, Relapse
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 – 25
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 64 (estimated)
- Sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Other
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About This Trial
Two key methods of GVHD prevention in allogeneic HSCT have a number of limitations: ex vivo T depletion is associated with an excess of infectious complications, and pharmacological immunosuppression with insufficient efficacy of GVHD prevention. Modern graft engineering technologies make it possible to create a graft with a balanced cell composition, reducing the risk of adverse events, in partic…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Informed consent signed by the patient (age 14 to 25 years) and/or his/her legal representative (age 0 to 18 years).
2. The patient has an indication for allogeneic hematopoietic stem cell transplantation (HSCT) established in accordance with the current regulatory framework
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Contacts