Preventing GVHD in children and young adults with blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.