Active — Not RecruitingPhase 1/2

ALLG AMLM26 INTERCEPT (Investigating Novel Therapy to Target Early Relapse and Clonal Evolution as Pre-emptive Therapy in AML): A Multi-arm, Precision-based, Recursive, Platform Trial

United States3 participantsStarted 2024-12-30

Plain-language summary

To demonstrate the efficacy of targeted and tailored sequential therapy in patients with AML.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Meets inclusion criteria outlined in the AMLM26 INTERCEPT Master Protocol including:
✓. Master Protocol Inclusion Criteria listed in Master Protocol Appendix 3.0.
✓. the mutation/mutations specified for this treatment arm in Master Protocol Appendix 2.0 Compendium of Actionable Domains and Allocation Rules
✓. Meets MRD eligibility for INTERCEPT therapy based on a screening sample taken no more than 42 days prior to cycle 1 of day 1 of treatment on this treatment arm. Refer to Master Protocol Appendix 5 for the definitions of MRD progression/failure. Eligibility will be confirmed by the MRD review committee.
✓. ECOG 0-2
✓. Patients entering this arm post-allogeneic stem cell transplantation will need to have an absolute lymphocyte count of .0.2 x 109/L and no evidence of active acute graft-versushost disease (GVHD)
✓. Subject must have adequate renal function as demonstrated by a creatinine clearance .
✓. aspartate aminotransferase (AST) . 3.0 \~ ULN

Exclusion criteria

✕. Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
✕. Acute/Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) or resolved HBV infection may participate. 6. Systemic chronic corticosteroid therapy (≥10 mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed. 7. For initial enrolment to INTERCEPT therapy, patients who have received previous TIM3 inhibitor treatment are excluded. This exclusion criteria does not apply to patients crossing-over from MBG453 arm to the combination MBG453 + azacitidine arm, unless MBG453 was ceased due to MBG453-related toxicity. 8. Patients with active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur should not be excluded 9. History of or current drug-induced interstitial lung disease or pneumonitis grade .2 10. Subject has been diagnosed with another malignancy, unless disease-free for at least 2 years and not needing active treatment. Patients with fully excised BCC/SCC/CIN or other minor malignancy are not excluded 11. Subject has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation 12. Use of any live vaccines against infectious diseases (i.e. Influenza, varicella, pneumococcus) within 4 weeks of initiation of study treatment 13. Impaired cardiac function or clinically significant cardiac disease, including any of the following:

What they're measuring

Safety and Adverse Events (AEs)

Timeframe: Through study completion; an average of 1 year

Trial details

NCT IDNCT06664879

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-31

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