RecruitingPhase 2NCT06536959

VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS

A Study of VA Combined With PD-1 Inhibitor in the Treatment of Relapsed and Refractory AML and High-risk MDS


Sponsor

Beijing 302 Hospital

Enrollment

67 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of venetoclax and azacitidine (VA) plus a PD-1 immunotherapy drug for patients with relapsed or treatment-resistant acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS — a bone marrow disorder that can turn into leukemia). **You may be eligible if...** - You have relapsed or treatment-resistant AML or high-risk MDS requiring chemotherapy - Your cancer did not respond to at least one prior induction treatment - Your liver, kidney, and bone marrow function are within acceptable ranges - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have another untreated cancer within the past 2 years - You received major cancer treatments within 2 weeks of starting the study - You have serious heart, lung, or infectious disease complications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPD-1 inhibitor, Venetoclax, Decitabine, Azacytidine

For AML patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 28 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days or azacytidine was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician. For MDS patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 14 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days or azacytidine was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician. The venetoclax starting dose is 100 mg on the first day, ramping up to 200 mg on the second day and finally 400 mg once daily. The steady daily dose (after ramp-up phase) should be reduced to 100 mg (coadministered with moderate CYP3A inhibitors or P-gp inhibitors) and 70 mg (coadministered with strong CYP3A4 inhibitors).


Locations(1)

Xiao-ning Gao

Beijing, Beijing Municipality, China

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NCT06536959


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