Patients Who Have Received Allo-HSCT
Conditions
Brief summary
The purpose of this study is to determine whether nilotinib is effective in the prophylaxis and treatment of CMV reactivation in allo-HSCT patients.
Detailed description
The purpose of this study is to determine whether nilotinib is effective in the prophylaxis and treatment of CMV reactivation in allo-HSCT patients. Prophylaxis Part: patients will be treated with nilotinib after their hemogram engraftment to prevent CMV reactivation Salvage Part: patients who have had intractable CMV reactivation after gancyclovir therapy will be treated with nilotinib
Interventions
DRUGnilotinib
nilotinib (200mg/tab) 1 tab everyday
Sponsors
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Part A: * Adult patients who have received allo-HSCT * Performance status ECOG 0-2 * Patients with CMV reactivation (defined as plasma CMV DNA copy numbers of more than 1000 copy numbers/ml by Quantitative-PCR) after allo-HSCT. * Patients with CMV reactivation that is uncontrollable by conventional first line agent (ganciclovir) for 2 or more weeks, or patients who are intolerable to ganciclovir treatment. Part B * Adult patients who have received allo-HSCT * Performance status ECOG 0-2 * Either the patient or his/her donor are CMV-IgG test positive * Patients with post-transplantation engraftment: stable myeloid engraftment (absolute neutrophil count 500/mm3) for at least 3 consecutive days, and stable megakaryocyte engraftment (platelet count 20k/uL) for at least 3 consecutive days. * Patient with no CMV reactivation before enrollment: a negative (undetectable) plasma CMV DNA Quantitative-PCR assay on blood collected within 7 days Patients without previous or current exposure to any prophylactic or therapeutic drugs for CMV reactivation
Exclusion criteria
* Patients with renal insufficiency: serum creatinine \> 2.5 mg/dL, * Patients with significant electrolyte deficiency after suitable supplement: \[K\] \<3.0mmol/L, \[Ca\]\< 2.0 mmol/L(corrected), or \[Mg\] \< 0.6 mmol/L. * Patients with hepatic dysfunction: alkaline phosphatase ≥2.5 times of the upper normal limit of the normal range (ULN); serum alanine or aspartate aminotransferase levels of \> 5 times ULN; a serum total bilirubin of \> 3 mg/dL * Patients with serum amylase and lipase \> 1.5 x ULN * Patients with history of HIV infection * Patients with unstable medical condition or any other history of serious/significant medical diseases deemed not appropriate to be included to this study as judged by investigators * Females patient who are pregnant or breast-feeding * Female patients of childbearing potential not using any reliable and appropriate contraception method(s) * Patients with life expectancy, as judged by the investigators, is less than 3 months * Patients with, as judged by the investigators, other contraindications of nilotinib administration, such as prolonged QTc, concurrent usage of drugs that possess possible severe drug-drug interactions with nilotinib, or had severe adverse effects in the previous exposure to nilotinib * Patients who cannot swallow capsules. * Patients who are unwilling or unable to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anti-CMV treatment free rate | 100 days after allo-HSCT (Day+100) | For prophylaxis part |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful salvage rate | up to 8 weeks | For salvage treatment part |
Countries
Taiwan
Outcome results
None listed