Preventing GVHD in children and young adults with blood cancers
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 Ruxolitinib At Children and Young Adults with Hemoblastosis After Hematopoietic Stem Cell Transplantation from an Unrelated or Haploidentic Donor
This study is testing a new treatment plan to see if it can help prevent graft-versus-host disease in children and young adults with blood cancers after they receive a transplant.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 1 Day to 21 Years |
| Sex | All |
| Sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology Academic / other |
| Drugs / interventions | vedolizumab, Ruxolitinib, cyclophosphamide, fludarabine |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06756152 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to prevent graft-versus-host disease (GVHD) in children and young adults diagnosed with various types of hematoblastosis, including acute lymphoblastic leukemia and malignant lymphoma. The approach involves a combination of post-transplantation cyclophosphamide, abatacept, vedolizumab, and ruxolitinib following a myeloablative conditioning regimen. Participants will receive a carefully monitored treatment protocol over a period of 120 to 180 days, depending on their risk factors, with follow-up observations extending for three years post-transplant. The study will assess the effectiveness of this combination therapy in reducing the incidence of GVHD and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are children and young adults under 21 years old with specific types of leukemia or malignant lymphoma.
Not a fit: Patients over 21 years old or those with uncontrolled infections or severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of GVHD, improving survival rates and quality of life for young patients undergoing hematopoietic stem cell transplantation.
How similar studies have performed: Other studies have shown promise in using similar approaches for GVHD prevention, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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 These patients may receive treatment according to the protocol, but the results will be evaluated separately
Where this trial is running
Moscow
- National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Maschan Michael,, MD, PhD
- Email: mmaschan@yandex.ru
- Phone: +79166512145
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.