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Anti-metabolites

Nadunolimab + Azacitidine for Preleukemia and 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
Patients aged ≥18 years
Males must meet specified criteria for sterility or agree to use contraception
Must not have
Other severe acute or chronic medical conditions that are active and not well controlled
Patients with any other known concurrent severe and/or uncontrolled medical condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights

Summary

This trial aims to test the safety and effectiveness of a new treatment strategy for high-risk forms of leukemia. The treatment involves using a drug called nadunolimab, either alone or in combination with

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
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I am 18 years old or older.
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I am sterile or agree to use contraception.
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My MDS is intermediate/high/very high risk and I've had 0-2 treatments.
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I can perform daily activities with minimal assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe or uncontrolled medical conditions.
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I do not have any severe or uncontrolled medical conditions.
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I am currently receiving cancer treatment for another cancer.
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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.
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I have leukemia that affects my brain and is not well-managed.
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I have HIV that is not currently under control.
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I have not had major surgery in the last 14 days.
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My condition is currently not under control.
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I need to take anti-TNF medication.

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
~2200

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,661 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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