NCT05158608

Brief Summary

This is a two arm open label phase III clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from any donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity conditioning regimen of fludarabine, busulfan (treosulfan). Patients will receive PTCy at different dose (25 mg/kg/day vs 50 mg/kg/day on day +3,+4 in combination with calcineurin inhibitors and mofetil mycophenolate) as GvHD prophylaxis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2022

Typical duration for phase_3

Status
unknown

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

First Submitted

Initial submission to the registry

December 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

December 12, 2021

Last Update Submit

December 17, 2021

Conditions

Graft Versus Host DiseaseHematologic MalignancyCyclophosphamide Adverse Reaction

Keywords

Allogeneic transplantationGraft-versus-host-disease prophylaxisPost-transplant cyclophosphamide

Outcome Measures

Primary Outcomes (2)

  • Incidence of acute graft-versus-host disease, grades II-IV

    MAGIC criteria

    180 days

  • Incidence of chronic GVHD, moderate and severe (NIH criteria)

    NIH criteria

    365 days

Secondary Outcomes (5)

  • Overall survival analysis

    365 days

  • Event-free survival analysis

    365 days

  • Non-relapse mortality analysis

    365 days

  • Incidence of graft failure and poor graft function

    365 days

  • Incidence of 30-Day Readmission

    365 days

Study Arms (2)

Cyclophosphamide on day +3,+4 at dose 50 mg/kg/day

ACTIVE COMPARATOR

Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 50 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.

Drug: Post-transplantation Cyclophosphamide at dose 50 mg/kg/day

Cyclophosphamide on day +3,+4 at dose 25 mg/kg/day

EXPERIMENTAL

Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 25 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.

Drug: Post-transplantation Cyclophosphamide at dose 25 mg/kg/day

Interventions

Post-transplantation Cyclophosphamide at dose 25 mg/kg/dayDRUG

Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 25 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.

Also known as: Endoxan, Cyphos
Cyclophosphamide on day +3,+4 at dose 25 mg/kg/day
Post-transplantation Cyclophosphamide at dose 50 mg/kg/dayDRUG

Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 50 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.

Also known as: Endoxan, Cyphos
Cyclophosphamide on day +3,+4 at dose 50 mg/kg/day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have an indication for allogeneic hematopoietic stem cell transplantation

You may not qualify if:

  • Uncontrolled bacterial or fungal infection at the time of enrollment
  • Requirement for vasopressor support at the time of enrollment
  • Karnofsky index \<30%
  • Pregnancy
  • Somatic or psychiatric disorder making the patient unable to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Graft vs Host DiseaseHematologic Neoplasms

Interventions

Cyclophosphamidetrihexyltetradecylphosphonium chloride

Condition Hierarchy (Ancestors)

Immune System DiseasesNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Elena Parovichnikova, MD, D.Sc

    National Research Center for Hematology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikhail Drokov, MD, Ph.D

CONTACT

+74956149042mdrokov@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 12, 2021

First Posted

December 15, 2021

Study Start

January 1, 2022

Primary Completion

January 1, 2024

Study Completion

January 1, 2025

Last Updated

January 11, 2022

Record last verified: 2021-12