Nilotinib for Cytomegalovirus Prophylaxis and Treatment After Allogeneic Hematopoietic Stem Cell Transplantation

National Taiwan University

Status and phase

Completed

Phase 2

Conditions

Patients Who Have Received Allo-HSCT

Treatments

Drug: nilotinib

Study type

Interventional

Funder types

Other

Identifiers

NCT01252017

201006057M

Details and patient eligibility

About

The purpose of this study is to determine whether nilotinib is effective in the prophylaxis and treatment of CMV reactivation in allo-HSCT patients.

Full 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

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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