Stopping chemotherapy for patients with Acute Myeloid Leukemia after successful treatment
Discontinuation of Hypomethylating Agent and Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Who Have Achieved Negative Measurable Residual Disease (MRD)
PHASE2 · H. Lee Moffitt Cancer Center and Research Institute · NCT06511882
This study is testing if adults with Acute Myeloid Leukemia who are in complete remission can safely stop their treatment after one year without the cancer coming back.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06511882 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether patients with Acute Myeloid Leukemia (AML) who have achieved complete remission can safely discontinue treatment with hypomethylating agents and venetoclax after one year without increasing the risk of relapse. The study focuses on adults who have been on frontline therapy and have shown measurable residual disease negativity. Participants will be monitored to assess the impact of treatment discontinuation on their disease status.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with AML who have achieved complete remission and are currently receiving treatment with azacitidine or decitabine in combination with venetoclax.
Not a fit: Patients who are not in complete remission or who have not achieved measurable residual disease negativity will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could allow patients to reduce their chemotherapy exposure while maintaining remission.
How similar studies have performed: While similar approaches have been explored, this specific discontinuation strategy in AML is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 18 years of age or older at the time of obtaining informed consent. * Diagnosed with Acute Myeloid Leukemia (AML) (non-M3) as defined by 2016 World Health Organization (WHO) * Eastern Cooperative Group (ECOG) performance status score ≤ 2 * Currently on frontline therapy with HMA (azacitidine or decitabine)/VEN and achieved Complete Remission (CR)/Complete Remission with incomplete marrow recovery (CRi) with MRD negativity defined as \< 0.1% by Multiparameter Flow Cytometry (MFC) * Within 12 months of starting HMA (azacitidine or decitabine)/VEN * Ineligible for or declined allogeneic hematopoietic cell transplantation (HCT) * Ability to understand and the willingness to sign a written informed consent document * Must agree to adhere to the study visit schedule and other protocol requirements * Patients must be able to provide adequate Bone Marrow (BM) aspirate and biopsy specimens for histopathological and Measurable Residual Disease analysis during the screening procedure Exclusion Criteria: * Use of cytotoxic chemotherapeutic agents, or experimental agents (agents that are not commercially available) for the treatment of AML within 28 days, or 5 half-lives, at the start of the study. Only patients who are receiving frontline HMA (azacitidine or decitabine)/VEN are potentially eligible, but if they had received a course of hydroxyurea prior to achieving CR/CRi, this is allowed. * Any serious medical condition or uncontrolled current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or will place the subject at unacceptable risk if he/she participates in the study. Controlled infections or other medical conditions on long-term therapy is allowed. * Patients who harbored TP53 mutation at diagnosis * AML with extramedullary involvement including central nervous system (CNS) involvement, myeloid sarcoma, and leukemia cutis requiring directed therapy at the time of enrollment. * Patient is pregnant.
Where this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Onyee Chan, MD — Moffitt Cancer Center
- Study coordinator: Gina Bellenger
- Email: Gina.Bellenger@moffitt.org
- Phone: 813-745-6138
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myeloid Leukemia, AML