Health TrialsbyHealthPanel

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)

ConditionsMyelodysplastic Syndrome(MDS)Acute Myelogenous Leukemia (AML)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About 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 does not accept healthy volunteers

Qualifiers

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.

Patients aged ≥18 years

Disqualifiers

Patients with any other known concurrent severe and/or uncontrolled medical condition including but not limited to diabetes, cardiovascular disease including hypertension, renal disease, or active uncontrolled infection, which could compromise participation in the study.

Patients on active antineoplastic or radiation therapy for a concurrent malignancy at the time of screening. Maintenance therapy, hormonal therapy, or steroid therapy for well-controlled malignancy is allowed.

Prior organ transplantation including allogenic stem-cell transplantation within 3 months prior to planned enrollment, active graft versus host disease (GVHD) >Grade 1 or requiring transplant-related immunosuppression with the exception of low dose cyclosporine and tacrolimus.

Patients with symptomatic CNS leukemia or patients with poorly controlled CNS leukemia.

Trial design

Design model

Single group

Treatments tested in this trial

  • Nadunolimab

    Drug

    Give by IV

  • Azacitidine

    Drug

    Given by IV

  • Venetoclax

    Drug

    Given by mouth (PO

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: ARM 1: All Patients Cycle 1Experimental treatment 1 intervention
Group B: ARM 1A: Cycle 2-24 for responder after Cycle 1 MonoExperimental treatment 3 interventions
Group C: ARM 1B: Cycle 2-24 for non responder after Cycle 1 ComboExperimental treatment 3 interventions
Group D: ARM 2: Relapsed/refractory AMLExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Safety and Adverse Events

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

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov
Apply now