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

This study is currently recruiting participants.
Verified November 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01252017
First received: November 24, 2010
Last updated: December 26, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Patients Who Have Received Allo-HSCT
Drug: nilotinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cytomegalovirus (CMV) Reactivation in Post-allogeneic Hematopoietic Stem Cell Transplantation(Allo-HSCT) Patients: Salvage and Prophylactic Treatments of Nilotinib

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • anti-CMV treatment free rate [ Time Frame: 100 days after allo-HSCT (Day+100) ] [ Designated as safety issue: No ]
    For prophylaxis part


Secondary Outcome Measures:
  • Successful salvage rate [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    For salvage treatment part


Estimated Enrollment: 36
Study Start Date: November 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: nilotinib
nilotinib (200mg/tab) 1 tab everyday
Other Name: tasigna

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252017

Contacts
Contact: Shang-Ju Wu, MD +886 2 23123456 ext 63629 wushangju@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Shang-Ju Wu, MD    +886 2 23123456 ext 63629    wushangju@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Shang-Ju Wu, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01252017     History of Changes
Other Study ID Numbers: 201006057M
Study First Received: November 24, 2010
Last Updated: December 26, 2012
Health Authority: Taiwan: Department of Health

ClinicalTrials.gov processed this record on April 17, 2014