Nadunolimab + Azacitidine for Preleukemia and Acute Myeloid Leukemia
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop all current medications, but you cannot use chemotherapeutic or anti-leukemic agents during the study, except for certain cases like intrathecal therapy or specific doses of cytarabine and hydroxyurea. There is a 7-day washout period for cytarabine before starting the study therapy.
What data supports the effectiveness of the drug combination of Nadunolimab, Azacitidine, and Venetoclax for preleukemia and acute myeloid leukemia?
Is the combination of Nadunolimab and Azacitidine safe for humans?
The combination of venetoclax and azacitidine, which is similar to Nadunolimab and Azacitidine, has been studied in patients with acute myeloid leukemia and is generally considered to have acceptable safety. Common side effects include blood-related issues and gastrointestinal problems, but the treatment is usually tolerable for patients.36789
What makes the drug combination of Nadunolimab, Azacitidine, and Venetoclax unique for treating preleukemia and acute myeloid leukemia?
This drug combination is unique because it includes Nadunolimab, which is not commonly used in standard treatments for acute myeloid leukemia. The addition of Nadunolimab to the established combination of Azacitidine and Venetoclax may offer a novel approach to improve treatment outcomes for patients with preleukemia and acute myeloid leukemia.12346
What is the purpose of this trial?
To evaluate safety and determine the recommended Phase II dose (RP2D). We hypothesize that targeting leukemia stem/progenitor cells (LSCs) with nadunolimab (IL1RAP antibody) alone or in combination with current therapies of azacitidine (HMA) and venetoclax (Bcl-2 inhibitor), is an effective treatment strategy for high-risk MDS and AML, and with a clinical trial we will establish the safety and the early efficacy of this approach.
Research Team
Gautam Borthakur, M.D.
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for patients with high-risk Myelodysplastic Syndrome (MDS) or Acute Myelogenous Leukemia (AML). Participants should not have received certain prior treatments and must meet specific health conditions. Detailed inclusion and exclusion criteria are provided to determine eligibility.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nadunolimab in combination with azacitidine, with or without venetoclax, for up to 24 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Azacitidine
- Nadunolimab
- Venetoclax
Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:
- Acute myeloid leukemia
- Chronic myelomonocytic leukemia
- Myelodysplastic syndromes
- Myelodysplastic syndromes
- Chronic myelomonocytic leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor