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

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

NCT ID: NCT06536959

Condition: Relapsed Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
Myelodysplastic Syndromes
Minimal Residual Disease

Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasm, Residual
Myelodysplastic Syndromes
Azacitidine
Decitabine
Venetoclax
Tislelizumab
Immune Checkpoint Inhibitors

Conditions: Keywords:
Venetoclax
Hypomethylation agen
PD-1 inhibitor

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine
Description: 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).
Arm group label: VA-PD1i

Other name: PD-1 inhibitor (Tislelizumab)

Other name: Venetoclax (ABT-199, GDC-0199)

Other name: Decitabine (Dacogen, 5-aza-2-deoxycytidine)

Other name: Azacitidine (5-Azacytidine, Ladakamycin)

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients diagnosed with relapsed and refractory acute myeloid leukemia (AML) and patients diagnosed with myelodysplastic syndrome (MDS) who require chemotherapy treatment. - Patients who did not respond or had disease recurrence after 1 course of induction chemotherapy or had positive immune residues after induction chemotherapy or positive molecular residues (if any) after induction chemotherapy. - Voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures. - The toxic and side effects caused by the last treatment should be recovered. - Eastern Cooperative Oncology Group score of 0 to 3 points. - The organ function is intact. - Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2×ULN (Upper Limit of Normal). - Creatinine≤2×ULN. - Bilirubin≤2×ULN. - Karnofsky≥70. - The expected survival period is at least 12 weeks. - Non-pregnant, non-breastfeeding women. Exclusion Criteria: - Suffering from other untreated or unrelieved malignant tumors within 2 years. - Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication. - Suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association [NYHA] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial. - Patients who are unwilling or unable to comply with the protocol. - Currently being treated with other systemic anti-tumor or anti-tumor research drugs. - Women who are pregnant or breastfeeding.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Xiao-ning Gao

Address:
City: Beijing
Zip: 100071
Country: China

Status: Recruiting

Contact:
Last name: Xiao-ning Gao

Phone: 86-010-66947169
Email: gaoxn@263.net

Contact backup:
Last name: Lei Xu

Phone: 86-010-66947174
Email: xulei800@hotmail.com

Start date: July 18, 2024

Completion date: July 31, 2027

Lead sponsor:
Agency: Beijing 302 Hospital
Agency class: Other

Source: Beijing 302 Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06536959