Trials / Unknown
UnknownNCT04541277
Combined Inhibition of PD-1 and DNA Hypomethylating Agent +/- Chemotherapy in High-risk AML or Elderly Patients With AML Who Are Unfit for Intensive Chemotherapy
A Phase II, Single Arm Study of Tislelizumab Combined With DNA Demethylation Agent +/- CAG Regimen in the Treatment of Patients With High-risk AML or AML Patients Older Than 60 Years of Age Who Are Unfit for Intensive Chemotherapy
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- Sponsor
- Chinese PLA General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well tislelizumab combined with DNA hypomethylation agent +/- CAG regimen (cytarabine, idarubicin / Aclarithromycin, rhG-CSF/ PEG-rhG-CSF) work in treating patients with high-risk acute myeloid leukemia (AML) or AML patients older than 60 years of age who are unfit for standard-dose chemotherapy. The expressions of PD-1 and PD-L1 are increased in AML cells. However, blocking the immune checkpoint alone has limited efficacy as a single agent in highly proliferative leukemia cells. During the recovery period after cytotoxic chemotherapy, the activation of PD-1/PD-L1 pathway may be increased and DNA hypomethylation agents can also up-regulate PD-1, PD-L1 and PD-L2 in AML patients. The up-regulation and activation of above immune checkpoint molecules are related to chemotherapy resistance. Therefore, adding chemotherapy and epigenetic regulation agents to Immune checkpoint blockade therapy may work better through overcoming drug resistance in AML treatment.
Conditions
- Acute Myeloid Leukemia, in Relapsed or Refractory
- Acute Myeloid Leukemia, Elderly, Unfit
- Acute Myeloid Leukemia With Positive Minimal Residual Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tislelizumab | Tislelizumab combined with DNA demethylation agent +/- CAG regimen |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2021-08-30
- Completion
- 2022-08-30
- First posted
- 2020-09-09
- Last updated
- 2020-09-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04541277. Inclusion in this directory is not an endorsement.