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

NCT ID: NCT01252017

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-11-30

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

Conditions

Patients Who Have Received Allo-HSCT

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Nilotinib

Single arm, open label study

Group Type: EXPERIMENTAL

nilotinib

Intervention Type: DRUG

nilotinib (200mg/tab) 1 tab everyday

Interventions

nilotinib

nilotinib (200mg/tab) 1 tab everyday

Intervention Type: DRUG

Other Intervention Names

tasigna

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shang-Ju Wu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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. 2018 Nov;24(11):2310-2315. doi: 10.1016/j.bbmt.2018.07.013. Epub 2018 Jul 17.

Reference Type: RESULT

PMID: 30026110 (View on PubMed)

Other Identifiers

201006057M

Identifier Type: -

Identifier Source: org_study_id