Status:
TERMINATED
Imatinib for Cytomegalovirus Prophylaxis and Treatment After Allogeneic Hematopoietic Stem Cell Transplantation
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Far Eastern Memorial Hospital
Tri-Service General Hospital
Conditions:
Patients Who Have Received Allo-HSCT
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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.
Detailed Description
This is a randomized, double-blind, multicenter phase II clinical trial. In the trial, post-allo-HSCT patients with signs of bone marrow engraftment and without evidence of CMV reactivation will be en...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03343600
Start Date
November 9 2017
End Date
August 31 2019
Last Update
September 11 2019
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Tzu Chi General Hospital
Hualien City, Taiwan
2
Far Eastern Memorial Hospital
New Taipei City, Taiwan
3
National Cheng Kung Hospital
Tainan, Taiwan
4
National Taiwan University Hospital
Taipei, Taiwan