Back to search results

NADUNOLIMAB for Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)

This study is testing a new drug called nadunolimab, given by IV, in combination with azacitidine (also IV) and possibly venetoclax (by mouth). It's for people with high-risk Myelodysplastic Syndrome (MDS) or Acute Myelogenous Leukemia (AML) that has come back or isn't responding to treatment. The main goal is to see how safe these drug combinations are and to find the best dose. Researchers also want to see if this treatment can help reduce or clear the cancer cells. You might be able to join if you are 18 or older and have MDS or AML that meets specific criteria, including how many prior treatments you've had.

Study design
This is an interventional study planning to enroll 40 participants. It aims to evaluate the safety and determine the recommended dose of nadunolimab in combination with other existing treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured throughout the study, which is expected to last an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06548230

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~40 participants
Updated 2026-03-09 on ClinicalTrials.gov
What's tested:NadunolimabAzacitidineVenetoclax

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events
Measured over Through study completion; an average of 1 year

Conditions

Myelodysplastic Syndrome(MDS)
Acute Myelogenous Leukemia (AML)

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Gautam Borthakur, MBBS · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Gautam Borthakur, MBBS
[email protected]
(713) 563-1586
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Arm 1: Diagnosis of MDS intermediate/high/very high risk by Revised International Prognostic Scoring System (IPSS-R), Untreated or up to 2 prior treatments.
Arm 2: Diagnosis of relapsed/refractory AML (per European Leukemia Network 2022) \[26\] receiving treatment as salvage 1-2. MDS or CMML treated with hypomethylating agent (HMA) therapies who progress to AML and have no available better therapies or are not candidates for available therapies, will be eligible at the time of progression to AML. 2. Patients aged ≥18 years 3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 4. Temporary prior measures such as apheresis, limited dose cytarabine or use of hydrea while eligibility work-up is being performed are allowed and not counted as a prior salvage 5. In the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of protocol therapy will be at least 2 weeks or at least 5 half-lives (whichever is shorter). The half-life for the therapy in question will be based on published pharmacokinetic literature (abstracts, manuscripts, investigator brochure's, or drug-administration manuals) and will be documented in the protocol eligibility document. 6. The toxicity from prior therapy should have resolved to Grade ≤1, however alopecia and sensory neuropathy Grade ≤2 not constituting a safety risk based on investigators judgement is acceptable. 7. The use of chemotherapeutic or anti-leukemic agents is not permitted during the study with the following exceptions: (1) intrathecal (IT) therapy for patients with controlled CNS leukemia at the discretion of the PI. (2) Use of 1-2 doses of cytarabine (up to 1.5 g/m2 each dose) for patients with rapidly proliferative disease is allowed up to 7 days before the start of study therapy (7 days washout). Use of hydroxyurea for patients with rapidly proliferative disease is allowed on study and before the start of study therapy and will not require a washout. These medications will be recorded in the case-report form. 8. Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS disease is permitted. Patients with a known history of CNS disease must have been treated with CNS directed therapy, have at least 2 consecutive LPs with no evidence of CNS leukemia, and must be clinically stable for at least 4 weeks prior to enrollment and have no ongoing neurological symptoms that in the opinion of the treating physician are related to the CNS disease 9. Serum biochemical values with the following limits:

What this trial measures

  • Safety and Adverse EventsThrough study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0