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

Patients Who Have Received Allo-HSCT Clinical Trial

Official title:

Cytomegalovirus (CMV) Reactivation in Post-allogeneic Hematopoietic Stem Cell Transplantation(Allo-HSCT) Patients: Salvage and Prophylactic Treatments of Nilotinib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252017
• Other study ID #: 201006057M
• Status: Completed
• Phase: Phase 2
• Start date: November 2010
• Est. completion date: November 2014

Study information

• Verified date: September 2018
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patients Who Have Received Allo-HSCT

Intervention

Drug:
• nilotinib
nilotinib (200mg/tab) 1 tab everyday

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Lin CT, Hsueh PR, Wu SJ, Yao M, Ko BS, Li CC, Hsu CA, Tang JL, Tien HF. Repurposing Nilotinib for Cytomegalovirus Infection Prophylaxis after Allogeneic Hematopoietic Stem Cell Transplantation: A Single-Arm, Phase II Trial. Biol Blood Marrow Transplant. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti-CMV treatment free rate	For prophylaxis part	100 days after allo-HSCT (Day+100)
Secondary	Successful salvage rate	For salvage treatment part	up to 8 weeks

External Links

•   Published article