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The purpose of this study is to determine whether nilotinib is effective in the prophylaxis and treatment of CMV reactivation in allo-HSCT patients.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nilotinib | Experimental | Single arm, open label study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nilotinib | Drug | nilotinib (200mg/tab) 1 tab everyday |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| anti-CMV treatment free rate | For prophylaxis part | 100 days after allo-HSCT (Day+100) |
| Measure | Description | Time Frame |
|---|---|---|
| Successful salvage rate | For salvage treatment part | up to 8 weeks |
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Inclusion Criteria:
Part A:
Part B
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shang-Ju Wu, MD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30026110 | Result | 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. |
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| ID | Term |
|---|---|
| C498826 | nilotinib |
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