NCT06756152 Preventing of GVHD with Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Ruxolitinib At Children and Young Adults with Hemoblastosis
| NCT ID | NCT06756152 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
| Condition | Biphenotypic Acute Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2026-07-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2024-07-10 with a primary completion date of 2026-07-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
GVHD prevention using a combination of post-transplantation cyclophosphamide in combination with abatacept, vedolizumab and Ruxolitinib in children and young adults with hematoloblastosis after myeloablative conditioning regimen with treosulfan/TBI, etoposide, fludarabine after HSCT from matched unrelated and haploidentical donors
Eligibility Criteria
Inclusion Criteria: 1\. Patients under the age of 21 years with following diseases: * acute lymphoblastic, * myeloblastic, * biphenotypic, * bilinear leukemia, * malignant lymphoma, * myelodysplastic syndrome, Exclusion Criteria: Age over 21 years * Patients with ALL outside clinical and hematological remission * Clinical status: * Lansky/Karnowski index \<70% (supplement No.1) * Heart function: left ventricular ejection fraction \<40% according to ultrasound of the heart1 * Kidney function: clearance of endogenous creatinine \< 70 ml / min * Liver function: total bilirubin, ALT, AST, ALP \> 2 norms * Lung function: lung capacity \<50%, for children who cannot carry out of respiratory function - oxygen saturation during pulse oximetry \<92% * Uncontrolled viral, fungal or bacterial infection. * Mental illness of the patient or caregivers, making it impossible to realize the essence of the study and compromising compliance with medical appointments and sanitary and hygienic regime 1 The
Frequently Asked Questions
Who can join the NCT06756152 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 21 Years, studying Biphenotypic Acute Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06756152 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06756152 currently recruiting?
Yes, NCT06756152 is actively recruiting participants. Visit ClinicalTrials.gov or contact Federal Research Institute of Pediatric Hematology, Oncology and Immunology to inquire about joining.
Where is the NCT06756152 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT06756152 clinical trial?
NCT06756152 is sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology. The trial plans to enroll 50 participants.
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