This study aim at examining whether blocking platelet-derived growth factor receptor-α by imatinib lowers the risk of post-allogeneic hematopoietic stem cell transplantation CMV infection.
This is a randomized, double-blind, multicenter phase II clinical trial. In the trial, post-allo-HSCT patients with signs of bone marrow engraftment and without evidence of CMV reactivation will be enrolled. All enrolled patients will be monitored for their blood CMV DNA copy numbers by Q-PCR and safety throughout the trial. In addition to their routine post-allo-HSCT care, eligible patients will receive imatinib (100mg/tablet, 2 tablets daily) or placebo (2 tablets daily) administration after myeloid engraftment (defined as absolute neutrophil count higher than 500 for three consecutive days). While receiving the trial therapy, patients will have a regular CMV surveillance every week by the quantification of plasma CMV DNA copies. During the administration of the investigational drugs, other concomitant anti-CMV prophylaxis treatments are prohibited. When a patient has any signs suggesting CMV infection that the treating physician determines that an anti-CMV therapy is indicated, the patient will be defined as failure of prophylaxis for the efficacy evaluation. Whether the conventional anti-CMV therapy is started or not, the investigational drugs with imatinib or placebo will be continued till at least Day+100 unless the patient is defined as prophylaxis failure or withdraws from the study including personal reasons, early mortality, disease recurrence after transplantation, pregnancy, or the investigator decides that the subject should be withdrawn for safety reasons or physical conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
5
Tzu Chi General Hospital
Hualien City, Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan
National Cheng Kung Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Tri-Service General Hospital
Number of participants free from initiating conventional anti-CMV treatment by Day+100 after allo-HSCT.
Investigator determined whether anti-CMV treatment is needed or not based on clinical judgment no matter therapeutic or preemptive treatment. Symptomatic CMV infection or CMV organ disease was defined as described by Ljungman et al., 2002.
Time frame: From first dosing to 100 days after allo-HSCT (Day+100)
Number of treatment-related adverse events (AE) by Day+100 after allo-HSCT.
Safety profile will be evaluated according to treatment-related adverse events (AE) per CTCAE 4.03 version.
Time frame: From first dosing to 100 days after allo-HSCT (Day+100)
Time to onset of CMV reactivation defined by peripheral blood CMV copies by Day+100 after allo-HSCT.
The peripheral blood CMV DNA copy numbers (copies/mL) were determined using a commercial kit with PCR method following its protocol. The CMV copy numbers are monitored on a weekly basis.
Time frame: From first dosing to 100 days after allo-HSCT (Day+100)
Time to onset of CMV disease diagnosed by investigator by Day+100 after allo-HSCT.
The diagnosis of CMV disease is based on clinical practice and the invasive procedure was encouraged to make the definite diagnosis. The reference to CMV organ disease definition was described by Ljungman et al., 2002.
Time frame: From first dosing to 100 days after allo-HSCT (Day+100)
Number of participants who had progressive hematological disease within 6 months after allo-HSCT.
Defined as any subject that is known to have a progressive hematological disease.
Time frame: 6 months post-transplant
Number of participants who died within 6 months after allo-HSCT.
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Taipei, Taiwan
Defined as any subject that is known to be dead.
Time frame: 6 months post-transplant