NCT05515029

Brief Summary

GVHD prevention using a combination of post-transplantation cyclophosphamide in combination with abatacept, vedolizumab and calcineurin inhibitor 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
6mo left

Started Aug 2022

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Aug 2022Oct 2026

First Submitted

Initial submission to the registry

August 23, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 23, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2026

Expected
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

August 23, 2022

Last Update Submit

September 26, 2023

Conditions

Acute Lymphoblastic LeukemiaMyeloblastic LeukemiaBiphenotypic Acute LeukemiaMalignant LymphomaMyelodysplastic SyndromesJuvenile Myelomonocytic Leukemia

Keywords

Hematopoetic stem cell transplantationposttransplant cyclophosphamidevedolizumabAMLALLchildrengraf versus host diseaseadolescents

Outcome Measures

Primary Outcomes (2)

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

    evaluation period is 120 days after HSCT

  • severe (3-5 degrees) side effects of conditioning

    evaluation period is 30 days after HSCT

Secondary Outcomes (5)

  • event free survival

    up to 100 days after HSCT

  • transplantation-associated mortality

    up to 100 days after HSCT

  • relapse free survival

    up to 100 days after HSCT

  • pathogen-specific immunoreconstitution

    after HSCT up to 180 days

  • reactivation of CMV

    after HSCT up to 180 days

Study Arms (1)

GVHD prevention: post-transplantation cyclophosphamide, abatacept, vedolizumab,calcineurin inhibitor

EXPERIMENTAL
Combination Product: GVHD prevention: post-transplantation cyclophosphamide, abatacept, vedolizumab, calcineurin inhibitor

Interventions

GVHD prevention: post-transplantation cyclophosphamide, abatacept, vedolizumab, calcineurin inhibitorCOMBINATION_PRODUCT

Cyclophosphamide 100 mg/kg/course on the days +3, +4 Abatacept 10 mg/kg/day on the days +5, +14, +28, +45, +60, +90, +120 Vedolizumab 10 mg/kg/day, max. 300 mg on the days -1, +14, +28

GVHD prevention: post-transplantation cyclophosphamide, abatacept, vedolizumab,calcineurin inhibitor

Eligibility Criteria

Age1 Day - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients under the age of 21 years with following diseases:
  • acute lymphoblastic,
  • myeloblastic,
  • biphenotypic,
  • bilinear leukemia,
  • malignant lymphoma,
  • myelodysplastic syndrome,

You may not qualify if:

  • Age over 21 years
  • Patients with ALL outside clinical and hematological remission
  • Clinical status:
  • Lansky/Karnowski index \<70%
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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-LymphomaLeukemia, Myelomonocytic, AcuteLeukemia, Biphenotypic, AcuteLymphomaMyelodysplastic SyndromesLeukemia, Myelomonocytic, Juvenile

Interventions

AbataceptvedolizumabCalcineurin Inhibitors

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidBone Marrow DiseasesMyelodysplastic-Myeloproliferative Diseases

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulinsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 25, 2022

Study Start

August 23, 2022

Primary Completion

August 15, 2024

Study Completion (Estimated)

October 16, 2026

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

RU(1)