NCT03343600

Brief Summary

This study aim at examining whether blocking platelet-derived growth factor receptor-α by imatinib lowers the risk of post-allogeneic hematopoietic stem cell transplantation CMV infection.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 9, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

September 27, 2017

Last Update Submit

September 9, 2019

Conditions

Patients Who Have Received Allo-HSCT

Outcome Measures

Primary Outcomes (1)

  • Number of participants free from initiating conventional anti-CMV treatment by Day+100 after allo-HSCT.

    Investigator determined whether anti-CMV treatment is needed or not based on clinical judgment no matter therapeutic or preemptive treatment. Symptomatic CMV infection or CMV organ disease was defined as described by Ljungman et al., 2002.

    From first dosing to 100 days after allo-HSCT (Day+100)

Secondary Outcomes (5)

  • Number of treatment-related adverse events (AE) by Day+100 after allo-HSCT.

    From first dosing to 100 days after allo-HSCT (Day+100)

  • Time to onset of CMV reactivation defined by peripheral blood CMV copies by Day+100 after allo-HSCT.

    From first dosing to 100 days after allo-HSCT (Day+100)

  • Time to onset of CMV disease diagnosed by investigator by Day+100 after allo-HSCT.

    From first dosing to 100 days after allo-HSCT (Day+100)

  • Number of participants who had progressive hematological disease within 6 months after allo-HSCT.

    6 months post-transplant

  • Number of participants who died within 6 months after allo-HSCT.

    6 months post-transplant

Study Arms (2)

Imatinib

EXPERIMENTAL

Imatinib (100 mg/tablet) 2# per day till D+100 after allo-HSCT or prophylaxis failure.

Drug: Imatinib

Placebo

PLACEBO COMPARATOR

Placebo 2# per day till D+100 after allo-HSCT or prophylaxis failure.

Drug: Placebo

Interventions

ImatinibDRUG

Imatinib 100 mg/tablet, 2 tablets daily

Imatinib
PlaceboDRUG

Placebos 2 tablets daily

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (Age ≧ 20) who received the first allo-HSCT are eligible;
  • Patients with underlying disease of acute leukemia in morphological remission, or myelodysplastic syndrome;
  • Received allo-HSCT with HLA-matched sibling or unrelated donors (at least 8/8 match for HLA-A/B/C/DR);
  • Evidence of post-transplantation neutrophil engraftment: absolute neutrophil count \> 500/mm3 for at least 3 consecutive days;
  • No detectable CMV infection before study enrollment: negative plasma CMV DNA surveillance within passing 2 weeks;
  • No previous post-transplantation anti-CMV therapy and no planned prophylactic anti-CMV therapy;
  • The patients has the ability to swallow tablets

You may not qualify if:

  • They have renal insufficiency: serum creatinine \> 2.5 mg/dL;
  • They have hepatic dysfunction: serum alanine or aspartate aminotransferase levels of \> 5 times the upper limit of the normal range or a serum total bilirubin of \> 3 mg/dL;
  • Patients with history of HIV infection;
  • Unstable post-BMT condition or other medical condition deemed not appropriate to be included to this study as judged by investigator;
  • Life expectancy less than 3 months;
  • Unwillingness or unable to give consent;
  • Patients with diseases that are positive for t(9;22) or BCR-ABL fusion gene.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Tzu Chi General Hospital

Hualien City, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Location

National Cheng Kung Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

Imatinib Mesylate

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Chien-Ting Lin, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2017

First Posted

November 17, 2017

Study Start

November 9, 2017

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

September 11, 2019

Record last verified: 2019-09

Locations

TW(5)