Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06536959

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

Led by Beijing 302 Hospital · Updated on 2024-08-05

67

Participants Needed

1

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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) 6432�d7ULN (Upper Limit of Normal).
  • Creatinine6432�d7ULN.
  • Bilirubin6432�d7ULN.
  • Karnofsky6432�d7ULN.
  • The expected survival period is at least 12 weeks.
  • Non-pregnant, non-breastfeeding women.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Xiao-ning Gao

Beijing, Beijing Municipality, China, 100071

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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