Trials / Unknown
UnknownNCT05376852
Decitabine and HQP1351-based Chemotherapy Regimen for the Treatment Advanced CML
Decitabine and HQP1351-based Chemotherapy Regimen for the Treatment Advanced Chronic Myeloid Leukemia
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Nanfang Hospital, Southern Medical University · Academic / Other
- Sex
- All
- Age
- 14 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well the combination of based decitabine and olverembatinib（HQP1351)chemotherapy work for the treatment of blast phase or accelerated phase chronic myelogenous leukemia. Drugs used in chemotherapy such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. HQP1351 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine and ponatinib based chemotherapy may help to control blast phase or accelerated phase chronic myelogenous leukemia.
Detailed description
Accelerated Phase CML treated with decitabine10mg/m2 d1-5 intravenously (IV) over 60 minutes on days 1-5 and olverembatinib（HQP1351) 40mg qod every 28 days.After completion of HQP1351 lead-in, patients will receive HQP1351 PO daily on days 1-28 of subsequent cycles. chronic myeloid leukaemia in blast phase:treated with decitabine 20mg/m2 d1-5 intravenously (IV) over 60 minutes on days 1-5 and HQP1351 40mg qod every 28 days,with or without other chemotherapy drugs
Conditions
- Chronic Myeloid Leukemia in Myeloid Blast Crisis
- Chronic Myeloid Leukaemia Transformation
- Chronic Myeloid Leukemia - Accelerated Phase
- Chronic Myeloid Leukemia in Lymphoid Blast Crisis
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | based decitabine and olverembatinib（HQP1351)chemotherapy | AP-CML treated with decitabine 10mg/m2 d1-5 intravenously (IV) over 60 minutes on days 1-5 and HQP1351 40mg qod every 28 days.After completion of HQP1351 lead-in, patients will receive HQP1351 PO qod on days 1-28 of subsequent cycles. BC-CML:treated with decitabine 20mg/m2 d1-5 IV on days 1-5 and HQP1351 40mg qod every 28 days,with or without other chemotherapy Drugs |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2022-05-17
- Last updated
- 2022-12-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05376852. Inclusion in this directory is not an endorsement.