PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT (NCT04669210) | Clinical Trial Compass
CompletedPhase 2
PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT
Russia128 participantsStarted 2020-11-03
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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;
What they're measuring
1
Incidence of acute GVHD grade II-IV
Timeframe: 125 days
Trial details
NCT IDNCT04669210
SponsorSt. Petersburg State Pavlov Medical University
. 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;