NCT06475820Active, not recruitingPhase 2/3
Preventing of GVHD With Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Baricitinib at Children and Young Adults With Hemoblastosis
Prospective Pilot Study of the Clinical Efficacy and Safety of the Method for Preventing a Graft-versus-host Disease Through the Agency of Using the Combination of Post-transplantation Cyclophosphamide With Abatacept, Vedolizumab and Baricitinib at Children and Young Adults With Hemoblastosis After Hematopoietic Stem Cell Transplantation From an Unrelated or Haploidentic Donor
Source: ClinicalTrials.gov · Last updated 23 Aug 2024
Brief summary (registry, in English)
GVHD prevention using a combination of post-transplantation cyclophosphamide in combination with abatacept, vedolizumab and and Baricitinib in children and young adults with hematoloblastosis after myeloablative conditioning regimen with treosulfan/TBI, cyclophosphamide/etoposide, fludarabine after HSCT from matched unrelated and haploidentical donors
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 17 May 2024
- Start date
- 1 Dec 2023
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Diseases
- Acute lymphoblastic leukaemia, Myelodysplastic syndromes, Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT06475820
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 150
- From 1 Dec 2023 to the primary completion date, 1 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 These patients may receive treatment according to the protocol, but the results will be evaluated separately
Lab values
- 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%
Age
- Age over 21 years
Other
- Patients with ALL outside clinical and hematological remission
Who the study is looking for
- following diseases:
- acute lymphoblastic,
- myeloblastic,
- biphenotypic,
- bilinear leukemia,
- malignant lymphoma,
- myelodysplastic syndrome, 2. Donors:
- voluntary fully HLA-matched unrelated,
- related haploidentical donors 3. Clinical center: National Medical Research Center of pediatric haematology, oncology and immunology named after Dmitry Rogachev" of the Ministry of Health of Russia 4. Availability of consent to conduct a study
Age in the registry: 1 day to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.