Preventing of GVHD With Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Baricitinib at Children and Young Adults With Hemoblastosis

NCT06475820 | Active Not Recruiting Phase 2

• 1 other identifier: NCHPOI-2023-07
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Biphenotypic Acute Leukemia; Malignant Lymphoma; Myelodysplastic Syndromes

Keywords

Hematopoetic stem cell transplantation; posttransplant cyclophosphamide; vedolizumab; hematoblastosis; ALL; AML; children; young adults; graft versus host disease

Outcome Measures

Primary Outcomes (3)

• Estimate the probability of developing acute GVHD stage II-IV after HSCT

  100 days after HSCT

• side effects of conditioning

  Explore the safety based on an assessment of the frequency of occurrence of: \- severe (3-5 degrees) side effects of conditioning during 1 month

  100 days after HSCT

• transplant-associated mortality

  100 days after HSCT

Secondary Outcomes (10)

• cumulative probability of relapse

  after HSCT by day + 100

• cumulative probability of relapse

  up to 2 years after HSCT

• event-free survival

  after HSCT by day + 100

• event-free survival

  up to 2 years after HSCT

• Probability of engraftment of leukocyte

  after HSCT by day + 100

Study Arms (1)

Baricitinib and Cyclophosphamide

EXPERIMENTAL

Baricitinib 4 mg/day per os (patient age \> 9 years), 2 mg/day (patient age \< 9 years), from day -3 to day +90 (after HSCT), orally, once a day.

Drug: Baricitinib

Interventions

Baricitinib DRUG

GVHD prevention using a combination of post-transplantation cyclophosphamide Prevention of GVHD: Cyclophosphamide 80 mg/kg/course on the days +3, +4 Abatacept 10 mg/kg/day on the days +5, +14, +28, +60, +90 Vedolizumab 10 mg/kg/day, max. 300 mg on the days 0, +14, +28, +60 Baricitinib 4 mg/day per os (patient age \> 9 years), 2 mg/day (patient age \< 9 years), from day -3 to day +90 (after HSCT), orally, once a day.

Also known as: Vedolizumab, Abatacept, Cyclophosphamide

Baricitinib and Cyclophosphamide

Eligibility Criteria

• Age: 1 Day - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Research Institute of Pediatric Hematology, Oncology and Immunology: lead

Study Sites (1)

Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology

Moscow, Samory-Mashela,1, 11198, Russia

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Leukemia, Biphenotypic, Acute; Lymphoma; Myelodysplastic Syndromes; Graft vs Host Disease

Interventions

baricitinib; vedolizumab; Abatacept; Cyclophosphamide

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 26, 2024
• Study Start: December 1, 2023
• Primary Completion: July 1, 2024
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)