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The goal of this clinical trial is to test the safety and efficacy of venetoclax plus CAG regimen in refractory/relapsed acute myeloid leukemia patients.
The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ven+CAG | Experimental | Venetoclax plus CAG regimen |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ven+CAG | Drug | 100 mg on the first day, and then gradually increase to the target dose of 400 mg (100 mg d1, 200 mg d2, 400 mg d3) within 3 days; After that, the drug continued to be administered until the 14th day, 400 mg/day. When combined with CYP3A or P-gp inhibitors (mainly voriconazole in this study), adjust the venetoclax dose to 100 mg/day. Ara-C 10mg/m2, ih, q12h × 14d; Acla 20mg/d × 4d; G-CSF 5ug/kg × 14d (WBC > 30 × 10^9/L pause) |
| Measure | Description | Time Frame |
|---|---|---|
| CR/CRi rate | the rate of complete remission or complete remission with incomplete hematologic recovery | 2 to 3 weeks after the end of cycle 1 (each cycle is 14 days) |
| CR/CRi rate | the rate of complete remission or complete remission with incomplete hematologic recovery | 2 to 3 weeks after the end of cycle 2 (each cycle is 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| MRD status | MRD-positive status was defined as FCM positivity in two consecutive BM samples at a 2-week interval, PCR positivity in two consecutive BM samples at a 2-week interval, or both FCM and PCR positivity in a single BM sample after the first-month post-HSCT. Positive FCM was defined as >0.01% of cells with a LAIPs phenotype in >1 BM samples after transplantation. The expressions of leukemia-associated genes were evaluated by TaqMan-based RT-PCR, including Wilms' tumor gene 1 (WT1) and genes which were determined in the diagnostic specimens. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wen-Jing Yu, M.D. | Contact | 18813187365 | yuwenjing789@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Wen-Jing Yu, M.D. | Peking University People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| C411062 | CAG protocol |
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| 2 to 3 weeks after the end of cycle 1 (each cycle is 14 days) |
| MRD status | MRD-positive status was defined as FCM positivity in two consecutive BM samples at a 2-week interval, PCR positivity in two consecutive BM samples at a 2-week interval, or both FCM and PCR positivity in a single BM sample after the first-month post-HSCT. Positive FCM was defined as >0.01% of cells with a LAIPs phenotype in >1 BM samples after transplantation. The expressions of leukemia-associated genes were evaluated by TaqMan-based RT-PCR, including Wilms' tumor gene 1 (WT1) and genes which were determined in the diagnostic specimens. | 2 to 3 weeks after the end of cycle 2 (each cycle is 14 days) |
| objective remission rate(ORR) | The percentage of people in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time. | 2 to 3 weeks after the end of cycle 1 (each cycle is 14 days) |
| objective remission rate(ORR) | The percentage of people in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time. | 2 to 3 weeks after the end of cycle 2 (each cycle is 14 days) |
| Progression-free survival (PFS) | From date of Ven plus CAG therapy beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | Throughout the whole research process, assessed up to 24 months |
| Overall survival | From date of Ven plus CAG therapy beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | Throughout the whole research process, assessed up to 24 months |
| The incidence of adverse events | According to Common Terminology Criteria for Adverse Events, CTCAE, V5.0, assessed up to 24 months | Throughout the whole research process, assessed up to 24 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |