Clinical trial · Interventional
Geriatric Assessment-Guided Treatment Selection in Older Adults With Acute Myeloid Leukemia
Geriatric Assessment-Guided Treatment Selection in Older Adults With Acute Myeloid Leukemia (The ALIGN-AML Trial)
NCT07735208CI-TRIAL-00119651ALIGN-AMLnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 2 randomized controlled trial to evaluate whether a geriatric assessment (GA)-guided treatment strategy reduces treatment-related toxicity and improves patient-centered outcomes compared with usual oncologist-directed care in adults aged 60 years and older with newly diagnosed AML.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GA-directed treatment regimens | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GA-guided treatment Arm
- description
- Participants will undergo a Practical Geriatric Assessment (PGA). Based on specific domains and measures within the PGA, participants will be categorized as fit, vulnerable, or frail and will receive treatment tailored to their physiologic status.
- interventionNames
- Drug: GA-directed treatment regimens
- type
- NO_INTERVENTION
- label
- Usual Care/Control Arm
- description
- Participants will undergo a structured Geriatric Assessment (GA) to determine physiologic fitness using the Practical Geriatric Assessment (PGA) and receive therapy determined by their treating oncologist not based on the GA results.
Primary outcomes (1)
- measure
- Treatment failure rate at 3 months
- timeFrame
- 3 months after treatment initiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 60 and above 2. A diagnosis of de novo, secondary or treatment-related acute myeloid leukemia (AML), other AML equivalent such as myeloid sarcoma, myelodysplastic syndrome in transformation to AML 1. AML diagnosis can be based on the World Health Organization (WHO) 2022 criteria or International Consensus Classification (ICC) 2022 criteria 2. The use of hydroxyurea, cytarabine (up to 1 gm total dose), or leukapheresis for cytoreduction is allowed 3. Patients with brief exposure to all-trans retinoic acid (ATRA), arsenic trioxide (ATO) or similar product for suspected acute promyelocytic leukemia (APL), who later turn out not to have APL, are eligible 4. The use of other cancer-directed treatments (e.g., hormonal treatment, targeted treatment, immunotherapy, radiation) other than chemotherapy for other concurrent malignancies is allowed 3. Able to provide informed consent Exclusion Criteria: 1. Acute promyelocytic leukemia 2. Unwilling to complete study procedures
References
Publications (1)
- BACKGROUNDBhatt VR, Wichman CS, Koll TT, Fisher AL, Wildes TM, Haddadin M, Berger AM, Armitage JO, Holstein SA, Maness LJ, Gundabolu K. A Phase II Trial of Geriatric Assessment-Guided Selection of Treatment Intensity in Older Adults With AML. Am J Hematol. 2025 Jul;100(7):1163-1172. doi: 10.1002/ajh.27694. Epub 2025 Apr 29. PMID 40298352