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Anti-metabolites

ARM 1B: Cycle 2-24 for non responder after Cycle 1 Combo for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Led By Gautam Borthakur, MBBS
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include immune system reactions, blood cell count changes, fatigue, nausea, infections due to lowered immunity from chemotherapy agents like Azacitidine and Venetoclax. Specific side effects related to Nadunolimab will also be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Adverse Events

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,030 Previous Clinical Trials
1,797,207 Total Patients Enrolled
Gautam Borthakur, MBBSPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
298 Total Patients Enrolled
~27 spots leftby Dec 2027
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