Comparison of PT-Cy at a Dose of 25 mg/kg/Day and PT-Cy at a Dose of 50 mg/kg/Day in GVHD Prophylaxis

NCT ID: NCT05158608

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Graft Versus Host Disease Hematologic Malignancy Cyclophosphamide Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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.

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Interventions

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

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.

Intervention Type DRUG

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

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.

Intervention Type DRUG

Other Intervention Names

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Endoxan Cyphos Endoxan Cyphos

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Center for Hematology, Russia

NETWORK

Sponsor Role lead

Responsible Party

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Mikhail Drokov

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elena Parovichnikova, MD, D.Sc

Role: PRINCIPAL_INVESTIGATOR

National Research Center for Hematology

Central Contacts

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Mikhail Drokov, MD, Ph.D

Role: CONTACT

+74956149042

Other Identifiers

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CY25

Identifier Type: -

Identifier Source: org_study_id

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