Acute Myeloid LeukemiaPhase 2ALIGN-AMLNCT07735208
Geriatric Assessment-Guided Treatment Selection in Older Adults With Acute Myeloid Leukemia
A Phase 2 study testing GA-directed treatment regimens in people with Acute Myeloid Leukemia, run by University of Rochester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- GA-directed treatment regimens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 30 Nov 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 and above
- 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
- AML diagnosis can be based on the World Health Organization (WHO) 2022 criteria or International Consensus Classification (ICC) 2022 criteria
- The use of hydroxyurea, cytarabine (up to 1 gm total dose), or leukapheresis for cytoreduction is allowed
- 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
- The use of other cancer-directed treatments (e.g., hormonal treatment, targeted treatment, immunotherapy, radiation) other than chemotherapy for other concurrent malignancies is allowed
- Able to provide informed consent
Who cannot join
- Acute promyelocytic leukemia
- Unwilling to complete study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Rochester Medicine
Rochester, New York, 14642
Kah Poh (Melissa) Loh, MD, MS, 585-275-5863, Kahpoh_Loh@URMC.Rochester.edu
About this study
Official title: Geriatric Assessment-Guided Treatment Selection in Older Adults With Acute Myeloid Leukemia (The ALIGN-AML Trial)
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.
Read the detailed description
Acute myeloid leukemia (AML) primarily affects older adults, yet treatment decision-making in this population remains largely inconsistent. Older adults with AML are highly heterogeneous with respect to physiologic reserve, functional status, cognition, and comorbidities, all of which strongly influence treatment tolerance and outcomes. Despite this heterogeneity, treatment decisions are often made rapidly and rely heavily on chronological age and clinician judgment, approaches that have been repeatedly shown to inadequately predict toxicity, early mortality, and functional decline. The proposed trial addresses a critical scientific question: whether a structured geriatric assessment (GA)-guided treatment strategy improves clinically meaningful outcomes compared with usual oncologist-directed care in older adults with AML. Although GA has been extensively validated as a prognostic and risk stratification tool in oncology and has improved care delivery in solid tumors, it has not been tested in a randomized controlled trial in AML, where treatment urgency, toxicity burden, and early adverse events are especially pronounced. This study therefore fills a major evidence gap at the intersection of geriatric oncology and hematologic malignancies.
This multicenter, prospective, randomized controlled trial is designed to evaluate whether a geriatric assessment (GA)-guided treatment strategy improves clinically meaningful outcomes compared with usual oncologist-directed care in older adults with newly diagnosed acute myeloid leukemia (AML). Approximately 120 adults aged 60 years and older will be enrolled across 3 academic and community institutions affiliated with the Cancer and Aging Research Group (CARG). Patients will be randomized in a 1:1 ratio to either a GA-guided treatment arm or a usual-care arm, with randomization stratified by study site and GA-defined fitness category (fit, vulnerable, frail). All patients will undergo a structured GA using the Practical Geriatric Assessment recommended by the American Society of Clinical Oncology and adapted for hematologic malignancies. However, GA results will be used to guide treatment selection only for participants assigned to the intervention arm.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- GA-directed treatment regimens
- Keywords
- AML, Geriatric Assessment, Acute myeloid leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GA-directed treatment regimensDrug
Fit, vulnerable, and frail patients will receive predefined regimens based on their GA results.
| Study group | Role | What they receive |
|---|---|---|
| GA-guided treatment Arm | Experimental | 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. Receives: Drug: GA-directed treatment regimens |
| Usual Care/Control Arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure rate at 3 months
Treatment failure is defined as the occurrence of any of the following within 3 months after treatment initiation: disease progression or relapse, death from any cause, treatment discontinuation for any reason except logistical reasons, absence of at least one agent in the initial treatment regimen for more than 30 days following the last day of the previous treatment cycle (temporary dose interruptions and cycle delays within the 30 day window are not considered treatment failure events), or initiation of an alternative treatment regimen or addition of an agent because of clinician documented concern for lack of efficacy or disease control.
Measured: 3 months after treatment initiation
Secondary outcomes (15)
Treatment failure rate at 6 months
Treatment failure will be assessed at 6 months (180 days) after treatment initiation and include any of the following events: • Disease progression or relapse • Death from any cause • Treatment discontinuation for any reason (except logistical) • Treatment delays, defined as: o Absence of at least one agent in the initial regimen for >30 days following the last day of prior treatment cycle o Temporary dose interruptions and cycle delays within the 30-day window are not considered treatment failure events • Initiation of an alternative treatment regimen or addition of an agent to the initial regimen due to clinician-documented concern for lack of efficacy or disease control, including but not limited to: o Failure to achieve the expected response o Rising blast percentage or worsening cytopenias attributed to disease o Loss of a prior response
Measured: 6 months after treatment initiation
Overall Response Rate
Best overall response from the initial treatment regimen within the first 6 months after treatment initiation. Overall response includes complete remission (CR), complete remission with incomplete hematologic recovery (CRi), and complete remission with partial hematologic recovery (CRh), assessed according to the European LeukemiaNet (ELN) 2022 response criteria.
Measured: 6 months after treatment initiation
Overall survival
Time from randomization to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive.
Measured: Up to 2 years after randomization
Event-free survival
Time from randomization to the first occurrence of failure to achieve complete remission (CR), complete remission with incomplete hematologic recovery (CRi), or complete remission with partial hematologic recovery (CRh), relapse after achieving CR, CRi, or CRh, or death from any cause.
Measured: Up to 2 years after randomization
Grade 3-5 toxicities
Proportion of participants with Grade 3 or higher nonhematologic adverse events and Grade 3 or higher neutropenia, thrombocytopenia, or anemia associated with the initial treatment regimen, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Asymptomatic laboratory abnormalities lasting 7 days or less that do not result in a dose modification or treatment hold will not be included.
Measured: 6 months after treatment initiation
Unplanned hospitalizations
Number of unplanned inpatient hospitalizations during the first 6 months after treatment initiation, excluding the initial hospitalization for treatment initiation.
Measured: 6 months after treatment initiation
Activities of Daily Living (ADL)
Change in Katz ADL total score from baseline. ADL measures independence in activities of daily living (including bathing, dressing, toileting, transferring, continence, and feeding). ADL ranges from 0 to 6, with higher scores representing greater independence in activities of daily living.
Measured: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90
Instrumental Activities of Daily Living (IADL)
Change in OARS IADL total score from baseline. IADL measures independence in instrumental activities of daily living (including using the telephone, travel, shopping, meal preparation, housework, taking medications, and handling money). IADL ranges from 0 to 14, with higher scores representing greater independence in instrumental activities of daily living.
Measured: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90
Fall History
Change in number of falls from baseline. More falls represent worse physical function.
Measured: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90
Short Physical Performance Battery (SPPB)
Change in SPPB total score from baseline. SPPB measures physical function and ranges from 0 to 12 (higher scores represent greater physical function).
Measured: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90
Montreal Cognitive Assessment (MoCA)
Change in MoCA total score from baseline. MoCA measure cognitive function and ranges from 0 to 30 (higher scores represent greater cognitive function).
Measured: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety
Change in PROMIS Anxiety 4a total score from baseline. PROMIS Anxiety measures anxiety and ranges from 4 to 20 (higher scores represent greater anxiety).
Measured: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90
Geriatric Depression Scale-15 (GDS-15)
Change in GDS-15 total score from baseline. GDS-15 measures depression and ranges from 0 to 15 (higher scores represent greater depression).
Measured: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90
Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
Change in FACT-Leu total score from baseline. FACT-Leu measures quality of life and is designed specifically for patients with leukemia. FACT-Leu ranges from 0 to 176, with higher scores representing better quality of life.
Measured: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90, day 180, day 360
Patient Reported Toxicities
Change in patient reported symptomatic toxicities measured using the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO CTCAE). Responses will be assessed longitudinally at the protocol specified assessment time points.
Measured: Baseline, during Cycle 1, at the start of Cycle 2 (or consolidation), Day 90, and Day 180. 28 day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2031 (estimated)
- Study completion30 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to the intervention or usual care arms using stratified randomized block design. Stratum will be defined by institution and fitness categories (fit, vulnerable, frail).
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Rising Tide Foundation
- Responsible party
- Principal investigator, Kah Poh Loh, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735208
- Sponsor's protocol ID
- UMLEU26044
- Acronym
- ALIGN-AML
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhatt 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.
PubMed 40298352
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Assessment-Guided Treatment Selection in Older Adults With Acute Myeloid Leukemia (The ALIGN-AML Trial)
- ClinicalTrials.gov ID
- NCT07735208
- Acronym / sponsor ID
- ALIGN-AML / UMLEU26044
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, Geriatric Assessment, Acute myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Rising Tide Foundation
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Nov 2031 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute myeloid leukemia (AML) primarily affects older adults, yet treatment decision-making in this population remains largely inconsistent. Older adults with AML are highly heterogeneous with respect to physiologic reserve, functional status, cognition, and comorbidities, all of which strongly influence treatment tolerance and outcomes. Despite this heterogeneity, treatment decisions are often made rapidly and rely heavily on chronological age and clinician judgment, approaches that have been repeatedly shown to inadequately predict toxicity, early mortality, and functional decline. The proposed trial addresses a critical scientific question: whether a structured geriatric assessment (GA)-guided treatment strategy improves clinically meaningful outcomes compared with usual oncologist-directed care in older adults with AML. Although GA has been extensively validated as a prognostic and risk stratification tool in oncology and has improved care delivery in solid tumors, it has not been tested in a randomized controlled trial in AML, where treatment urgency, toxicity burden, and early adverse events are especially pronounced. This study therefore fills a major evidence gap at the intersection of geriatric oncology and hematologic malignancies.
This multicenter, prospective, randomized controlled trial is designed to evaluate whether a geriatric assessment (GA)-guided treatment strategy improves clinically meaningful outcomes compared with usual oncologist-directed care in older adults with newly diagnosed acute myeloid leukemia (AML). Approximately 120 adults aged 60 years and older will be enrolled across 3 academic and community institutions affiliated with the Cancer and Aging Research Group (CARG). Patients will be randomized in a 1:1 ratio to either a GA-guided treatment arm or a usual-care arm, with randomization stratified by study site and GA-defined fitness category (fit, vulnerable, frail). All patients will undergo a structured GA using the Practical Geriatric Assessment recommended by the American Society of Clinical Oncology and adapted for hematologic malignancies. However, GA results will be used to guide treatment selection only for participants assigned to the intervention arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to the intervention or usual care arms using stratified randomized block design. Stratum will be defined by institution and fitness categories (fit, vulnerable, frail).
| Arm | Type | Receives |
|---|---|---|
| GA-guided treatment Arm | Experimental | Drug: GA-directed treatment regimensParticipants 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. |
| Usual Care/Control Arm | No intervention | –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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 60 and above
- 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
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Acute promyelocytic leukemia
- Unwilling to complete study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GA-directed treatment regimensFit, vulnerable, and frail patients will receive predefined regimens based on their GA results. | Drug | GA-guided treatment Arm |
Primary outcome
Treatment failure rate at 3 months
Time frame: 3 months after treatment initiation
Treatment failure is defined as the occurrence of any of the following within 3 months after treatment initiation: disease progression or relapse, death from any cause, treatment discontinuation for any reason except logistical reasons, absence of at least one agent in the initial treatment regimen for more than 30 days following the last day of the previous treatment cycle (temporary dose interruptions and cycle delays within the 30 day window are not considered treatment failure events), or initiation of an alternative treatment regimen or addition of an agent because of clinician documented concern for lack of efficacy or disease control.
15 secondary outcomes
Treatment failure rate at 6 months
Time frame: 6 months after treatment initiation
Overall Response Rate
Time frame: 6 months after treatment initiation
Overall survival
Time frame: Up to 2 years after randomization
Event-free survival
Time frame: Up to 2 years after randomization
Grade 3-5 toxicities
Time frame: 6 months after treatment initiation
Unplanned hospitalizations
Time frame: 6 months after treatment initiation
Activities of Daily Living (ADL)
Time frame: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90
Instrumental Activities of Daily Living (IADL)
Time frame: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90
Fall History
Time frame: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90
Short Physical Performance Battery (SPPB)
Time frame: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90
Montreal Cognitive Assessment (MoCA)
Time frame: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety
Time frame: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90
Geriatric Depression Scale-15 (GDS-15)
Time frame: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90
Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
Time frame: Collected baseline, start of cycle 2 or consolidation (28 day cycle), day 90, day 180, day 360
Patient Reported Toxicities
Time frame: Baseline, during Cycle 1, at the start of Cycle 2 (or consolidation), Day 90, and Day 180. 28 day cycle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 40298352Bhatt 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.
- National Cancer Institute Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Leukemia - Acute Myeloid Leukemia (AML), 2025Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GA-directed treatment regimens in people with Acute Myeloid Leukemia, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kah Poh (Melissa) Loh, MD, MS (585-275-5863, Kahpoh_Loh@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure rate at 3 months (time frame: 3 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07735208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.