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)
M.D. Anderson Cancer Center
Summary
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.
Description
Primary Objectives: To determine the safety and recommended phase 2 dose (RP2D) of nadunolimab in combination with azacitidine in intermediate/high/very high risk MDS (International prognostic scoring system revised/IPSS-R) who are untreated or had up to 2 prior treatments (Arm 1) or in combination with azacitidine and venetoclax in patients with relapsed/refractory AML receiving treatment as first or second salvage (Arm 2). Secondary Objectives: To assess the complete remission (CR)+ CR with incomplete count recovery (CRi) + partial remission (PR)+ morphologic leukemia free state (MLFS) ra…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis * 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 Onc…
Interventions
- DrugNadunolimab
Give by IV
- DrugAzacitidine
Given by IV
- DrugVenetoclax
Given by mouth (PO
Location
- MD Anderson Cancer CenterHouston, Texas