PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT (PTCyRuxo)

STATUS

Recruiting
End date

Dec 19, 2024
participants needed

128
sponsor

St. Petersburg State Pavlov Medical University

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Updated on 19 April 2022

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remission

graft versus host disease

tacrolimus

mycophenolate mofetil

cyclophosphamide

flow cytometry

cell transplantation

blast cells

Summary

This is multicenter investigator-initiated randomized open-label phase II clinical trial to compare prophylaxis of graft versus host disease treated with tacrolimus and mycophenolate mofetil versus ruxolitinib after post-transplant cyclophosphamide.

In total 128 patients will be included in the study. After inclusion into the study and performing of transplantation patients will be randomized in 1:1 proportion in two arms (64 patients per arm): arm A will include patients who will be treated with cyclophosphamide and ruxolitinib for GVHD prophylaxis; arm B will include patients who will be treated with cyclophosphamide, tacrolimus and MMF for GVHD prophylaxis. After the end of the treatment patients will be followed-up during two years.

Details

Condition	Graft-versus-host-disease, Stem Cell Transplant Complications, Acute Myeloid Leukemia, Acute Lymphoid Leukemia
Treatment	mycophenolate mofetil, Tacrolimus, Ruxolitinib
Clinical Study Identifier	NCT04669210
Sponsor	St. Petersburg State Pavlov Medical University
Last Modified on	19 April 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Informed consent to participate in the study, signed by the patient
	Diagnosis: acute lymphoblastic or acute myeloblastic leukemia
	Morphological remission, defined as less than 5% of blasts by microscopy or flow cytometry with a peripheral leukocyte level of more than 1.500 μL. It is acceptable to include patients without restored platelets or erythrocytes
	Indications for performing allogeneic hematopoietic stem cell transplantation, determined by the participating center in accordance with local medical practice
	Unrelated or haploidentical donor
	Age 18-70 years
	Functional status according to ECOG scale 0-2 score
Exclusion Criteria
	Repeated allogeneic transplantation, regardless of the indications for its implementation
	Source of graft - umbilical cord stem cells
	Any ex vivo modification of the graft with the exception of separation or washing of red blood cells
	The presence of more than 5% of clonal tumor cells according to flow cytometry in the presence of morphological remission
	Diagnosis: acute promyelocytic leukemia
	Severe organ failure: creatinine more than 2 ULN; ALT, AST more than 5 ULN; bilirubin more than 1.5 ULN; respiratory failure more than 1 grade
	Unstable hemodynamics, requiring the introduction of vasopressors
	Uncontrolled bacterial or fungal infection at the time of randomization, determined by the level of CRP> 70 mg/l with adequate antibacterial or antifungal therapy
	Rhythm disturbances that persist despite adequate antiarrhythmic therapy: a tachysystolic form of atrial fibrillation, ventricular arrhythmias V gradation according to Laun, AV block of III degree
	Decrease in ejection fraction according to echocardiography less than 40%
	Angina of more than II functional class or unstable angina
	Another severe concomitant pathology, which according to the attending physician does not allow the patient to be included in the study
	Pulmonary pathology with a decrease in FEV1 of less than 60% or pulmonary diffusion capacity of less than 60%
	Inability to quit smoking for up to 6 months after transplantation
	Pregnancy or refusal to perform highly effective contraception for 6 months after transplantation
	Highly effective contraceptive methods include
	Total abstinence: if it corresponds to the preferred and customary way of life of the patient. Periodic abstinence (for example, calendar, ovulation, symptothermal, postovulation methods) and interrupted sexual intercourse are not considered acceptable methods of contraception
	Female sterilization (surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before the start of the therapy being studied. In the case of ovariectomy only, the reproductive status of the woman must be confirmed using a subsequent analysis of hormones
	Sterilization of the male partner (at least 6 months before screening). For women participating in the study, the sexual partner after a vasectomy should be the only partner
	Use of oral, injectable or implanted hormonal contraceptive drugs, intrauterine devices or contraceptive systems, or other forms of hormonal contraception with similar efficacy (failure rate less than 1%), for example, hormonal vaginal rings or transdermal hormonal contraceptives
	Somatic or mental pathology not allowing to sign informed consent

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PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT (PTCyRuxo)