PTCy and Ruxolitinib GVHD Prophylaxis in Myelofibrosis
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|ClinicalTrials.gov Identifier: NCT02806375|
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Primary Myelofibrosis Myeloproliferative Disorders||Procedure: Allogeneic hematopoietic stem cell transplantation Drug: Busulfan Drug: Fludarabine monophosphate Drug: Cyclophosphamide Drug: Ruxolitinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Graft-versus-host Disease Prophylaxis With Post-transplantation Cyclophosphamide and Ruxolitinib in Patients With Myelofibrosis|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||April 2019|
|Experimental: PTCy and ruxolitinib||
Procedure: Allogeneic hematopoietic stem cell transplantation
Day 0: Infusion of unmanipulated graft
Other Name: HSCT
Days -5 through -3: Busulfan 1 mg/kg po qid №10
Drug: Fludarabine monophosphate
Days -7 through -2: 30 mg/m2/day iv qd x 6 days
Day +3 and +4: 50 mg/kg/day iv qd
Other Name: Cytoxan
Days -8 through -2 15 mg tid
Days +5 through +100: 7.5 mg bid
- Incidence of acute graft-versus-host disease, grades II-IV [ Time Frame: 180 days ]
- Incidence of chronic GVHD, moderate and severe (NIH criteria) [ Time Frame: 365 days ]
- Incidence of primary or secondary graft failure [ Time Frame: 60 days ]
- Non-relapse mortality analysis [ Time Frame: 365 days ]Non-relapse mortality is defined as any death in absence of relapse or progressive disease. Summarized using Kaplan-Meier and cumulative incidence estimates.
- Overall survival analysis [ Time Frame: 365 days ]Summarized using Kaplan-Meier and cumulative incidence estimates.
- Event-free survival analysis [ Time Frame: 365 days ]Event is defined as relapse or death in the specified time frame. Summarized using Kaplan-Meier and cumulative incidence estimates.
- Relapse rate analysis [ Time Frame: 365 days ]Summarized using Kaplan-Meier and cumulative incidence estimates.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 100 days ]Toxicity parameters based on NCI CTCAE 4.03 grades: hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), mucositis (attending physician assessment), hemorrhagic cystitis (attending physician assessment), cardiotoxicity (ECG, echocardiography). Additional toxicity parameters: incidence and severity of veno-occlusive disease, incidence of transplant-associated microangiopathy
- Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence [ Time Frame: 100 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806375
|First Pavlov State Medical University of St. Petersburg|
|Saint-Petersburg, Russian Federation, 197089|
|Study Director:||Boris V. Afanasyev, Professor||St. Petersburg State Pavlov Medical University|