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Not yet recruitingPhase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether using an older adult health assessment to choose treatment can reduce treatment side effects and improve outcomes that matter to patients. It compares this approach with care chosen by the cancer doctor for adults age 60 or older with newly diagnosed acute myeloid leukemia (AML), a blood cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 60 or older.
  • Have AML, including AML that follows another disease or past treatment. Certain related cancers also qualify, such as myeloid sarcoma or myelodysplastic syndrome changing into AML.
  • Be able to understand and agree to join the study.
  • Prior treatment to lower blood cell counts is allowed with hydroxyurea, cytarabine (up to 1 gram total), or leukapheresis, a procedure that removes white blood cells.
  • Brief treatment for suspected acute promyelocytic leukemia (APL) is allowed if later tests show you do not have APL.
  • Treatment for another current cancer is allowed if it is not chemotherapy. Examples include hormone treatment, targeted treatment, immune treatment, or radiation.

Who can't join

  • Have acute promyelocytic leukemia (APL), a type of AML.
  • Are not willing to complete the study procedures.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

NY