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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01252017
Recruitment Status : Unknown
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : December 2, 2010
Last Update Posted : December 27, 2012
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Patients Who Have Received Allo-HSCT Drug: nilotinib Phase 2

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2010
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Nilotinib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nilotinib Drug: nilotinib
nilotinib (200mg/tab) 1 tab everyday
Other Name: tasigna



Primary Outcome Measures :
  1. anti-CMV treatment free rate [ Time Frame: 100 days after allo-HSCT (Day+100) ]
    For prophylaxis part


Secondary Outcome Measures :
  1. Successful salvage rate [ Time Frame: up to 8 weeks ]
    For salvage treatment part



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01252017     History of Changes
Other Study ID Numbers: 201006057M
First Posted: December 2, 2010    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: November 2012