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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 29, 2014