Nadunolimab + Azacitidine for Preleukemia and Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

Gautam Borthakur | MD Anderson Cancer ...

Overseen ByGautam Borthakur, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

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.

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

I am 18 years old or older.

I am sterile or agree to use contraception.

My MDS is intermediate/high/very high risk and I've had 0-2 treatments.

I can perform daily activities with minimal assistance.

Exclusion Criteria

I do not have any severe or uncontrolled medical conditions.

I am currently receiving cancer treatment for another cancer.

I haven't had an organ transplant in the last 3 months, nor do I have severe graft-versus-host disease or need immunosuppression due to a transplant.

I have leukemia that affects my brain and is not well-managed.

I have HIV that is not currently under control.

I have not had major surgery in the last 14 days.

My condition is currently not under control.

I need to take anti-TNF medication.

Participant Groups

The trial tests the safety and optimal dose of Nadunolimab, alone or combined with Azacitidine and/or Venetoclax, in treating MDS/AML. It aims to see if targeting leukemia stem cells with this combination can be an effective treatment strategy.

4Treatment groups

Experimental Treatment

Group I: ARM 2: Relapsed/refractory AMLExperimental Treatment3 Interventions

Group II: ARM 1B: Cycle 2-24 for non responder after Cycle 1 ComboExperimental Treatment3 Interventions

Group III: ARM 1A: Cycle 2-24 for responder after Cycle 1 MonoExperimental Treatment3 Interventions

Group IV: ARM 1: All Patients Cycle 1Experimental Treatment1 Intervention

Azacitidine is already approved in European Union, United States, Canada, Japan, Australia for the following indications:

🇪🇺 Approved in European Union as Vidaza for: