Actively Recruiting
A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With or Without Venetoclax) in Patients With Myelodysplastic Syndrome and Acute Myelogenous Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-03-09
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and optimal dosing of nadunolimab, an IL1RAP antibody, combined with azacitidine, with or without venetoclax, in patients with high-risk Myelodysplastic Syndrome (MDS) and relapsed or refractory Acute Myelogenous Leukemia (AML). The study aims to target leukemia stem and progenitor cells to explore this treatment strategy's early safety and effectiveness. This Phase 1B/2A trial includes patients untreated or with limited prior therapies for MDS and those receiving salvage therapy for AML. Participants receive nadunolimab intravenously, combined with azacitidine also given intravenously. In some cases, venetoclax is added and taken by mouth. The trial has two main arms: one for patients with intermediate to very high-risk MDS and another for relapsed or refractory AML patients. Treatment cycles continue up to 24 cycles depending on response, with adjustments based on patient outcomes. The trial also explores biomarkers, gene analysis, and drug exposure to better understand treatment effects. During the study, participants undergo safety monitoring for adverse events, laboratory tests to assess blood counts and organ function, and evaluations of response to treatment using established leukemia criteria within six treatment cycles. Researchers also assess duration of response and collect samples for biomarker and genetic analysis. The trial involves regular visits for treatment administration and ongoing assessments, with an average participation duration of about one year to monitor safety and early efficacy.
CONDITIONS
Brief Title
A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of intermediate, high, or very high risk Myelodysplastic Syndrome (MDS) untreated or with up to 2 prior treatments (Arm 1).
- Diagnosis of relapsed or refractory Acute Myelogenous Leukemia (AML) receiving first or second salvage treatment (Arm 2).
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Prior limited treatments allowed during eligibility work-up (e.g., apheresis, low-dose cytarabine).
- At least 2 weeks or 5 half-lives since prior treatment before starting protocol therapy.
- Toxicity from prior therapy resolved to Grade 1 or lower, except alopecia and sensory neuropathy Grade 2 or lower.
- No concurrent chemotherapeutic or anti-leukemic agents except specific allowed exceptions.
- Controlled CNS leukemia if present, with stable neurological status for at least 4 weeks.
- Adequate renal function with creatinine clearance ≥ 40 mL/min.
- Bilirubin less than 1.5 times upper normal limit unless due to Gilbert's syndrome.
- AST or ALT less than or equal to 2 times upper normal limit (up to 3 times if related to leukemia).
- White blood cell count less than 10 x 10^9/L; hydroxyurea allowed to reduce count.
- Ability to provide signed informed consent.
- Females must be sterile, postmenopausal, or have a negative pregnancy test before treatment.
- Agreement to use contraception during and after study treatment.
You will not qualify if you...
- Any uncontrolled severe medical condition including diabetes, cardiovascular disease, renal disease, or active infection.
- Active antineoplastic or radiation therapy for another cancer, except maintenance, hormonal, or steroid therapy for well-controlled malignancy.
- Organ transplantation within 3 months or active graft versus host disease above Grade 1.
- Symptomatic or poorly controlled CNS leukemia.
- Known uncontrolled HIV infection.
- Active hepatitis B or C infection without undetectable viral load in past 3 months.
- Major surgery within 14 days before starting treatment.
- Severe uncontrolled conditions like colitis, inflammatory bowel disease, psychiatric disorders with active suicidal ideation.
- Active infections requiring systemic therapy within 48 hours.
- Use of anti-TNF drugs.
- Inability or unwillingness to comply with the study protocol.
- Live vaccination within 28 days before starting therapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 cycles
Participants receive nadunolimab in combination with azacitidine, with or without venetoclax, depending on their diagnosis and treatment arm. Treatment cycles continue based on response and protocol up to 24 cycles.
Multiple visits for each treatment cycle
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
Gautam Borthakur, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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