RECRUITING

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

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Conditions

AML

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-12-30
Study Completion:2028-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06664879

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Meets inclusion criteria outlined in the AMLM26 INTERCEPT Master Protocol including:
  2. 1. Master Protocol Inclusion Criteria listed in Master Protocol Appendix 3.0.
  3. 2. the mutation/mutations specified for this treatment arm in Master Protocol Appendix 2.0 Compendium of Actionable Domains and Allocation Rules
  4. 2. 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.
  5. 3. ECOG 0-2
  6. 4. 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)
  7. 5. Subject must have adequate renal function as demonstrated by a creatinine clearance .
  8. 1. aspartate aminotransferase (AST) . 3.0 \~ ULN
  9. 2. alanine aminotransferase (ALT) . 3.0 \~ ULN
  10. 3. bilirubin . 1.5 \~ ULN (unless bilirubin rise is due to Gilbert fs syndrome or of nonhepatic origin) 7. Agrees to follow the recommended contraception procedures for this treatment domain
  1. * 10mg/day prednisolone for graft vs host disease 3. Subject is HIV positive 4. Patients with .5% myeloblasts in bone marrow on morphologic assessment 5. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
  2. 1. Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
  3. 2. 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:
  4. * Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade . 2) with an LVEF of \<40%, uncontrolled hypertension or clinically significant arrhythmia
  5. * Acute myocardial infarction or unstable angina pectoris . 3 months prior to study entry 14. Known hypersensitivity to azacitidine or mannitol.

Contacts and Locations

Study Contact

Courtney DiNardo, MD
CONTACT
(713) 794-1141
cdinardo@mdanderson.org

Principal Investigator

Courtney DiNardo, MD
PRINCIPAL_INVESTIGATOR
The University of Texas MD Anderson Cancer Center

Study Locations (Sites)

The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Courtney DiNardo, MD, PRINCIPAL_INVESTIGATOR, The University of Texas MD Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-30
Study Completion Date2028-07-31

Study Record Updates

Study Start Date2024-12-30
Study Completion Date2028-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • AML