Status:
COMPLETED
Nilotinib for Cytomegalovirus Prophylaxis and Treatment After Allogeneic Hematopoietic Stem Cell Transplantation
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Patients Who Have Received Allo-HSCT
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ni...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01252017
Start Date
November 1 2010
End Date
November 1 2014
Last Update
September 12 2018
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100