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

NCT01252017 | Completed Phase 2

• 1 other identifier: 201006057M
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Who Have Received Allo-HSCT

Outcome Measures

Primary Outcomes (1)

• anti-CMV treatment free rate

  For prophylaxis part

  100 days after allo-HSCT (Day+100)

Secondary Outcomes (1)

• Successful salvage rate

  up to 8 weeks

Study Arms (1)

Nilotinib

EXPERIMENTAL

Single arm, open label study

Drug: nilotinib

Interventions

nilotinib DRUG

nilotinib (200mg/tab) 1 tab everyday

Also known as: tasigna

Nilotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

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

  PMID: 30026110 RESULT

MeSH Terms

Interventions

nilotinib

Study Officials

• Shang-Ju Wu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: December 2, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: September 12, 2018

Record last verified: 2018-09

Locations

TW (1)