Clinical trial · Interventional
Study of a Geriatric Assessment to Plan a Treatment Approach for Older People With Various Blood Disorders
Phase II Study of a Geriatric Assessment-Driven, Risk-Adapted Allogeneic Hematopoietic Cell Transplant Strategy for Older Patients With Myeloid Malignancies
- 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 study will evaluate whether a geriatric assessment can lead to better treatment outcomes in older patients (age 60+) with a myeloid malignancy including acute myeloid leukemia, ,myelodysplastic syndromes, myeloproliferative neoplasms, or related blood disorders who are going to receive chemotherapy or another treatment to prepare the body for an allogeneic hematopoietic stem cell transplant (allo-HCT). The geriatric assessment includes looking at patients' cognitive function (thinking processes), physical function, mobility (ability to move the body), mood, nutrition, and current medications to help decide the type of treatment they'll receive. Another purpose of this study is to see whether use of the geriatric assessment improves participants' quality of life. We will evaluate participants' quality of life through questionnaires.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypical Chronic Myeloid Leukemia | Atypical Chronic Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Myelomonocytic Leukemia | Chronic Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Myelodysplastic/Myeloproliferative Overlapping Syndrome | — | UNRESOLVED | — |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Myeloproliferative Neoplasms | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic CD34+ selected stem cells | Procedure | — | UNRESOLVED |
| conditioning regimen | Drug | — | UNRESOLVED |
| Geriatric assessment (GA) pre-transplant | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Geriatric participants with various blood disorders
- description
- 1. Geriatric assessment (GA) pre-transplant 2. Risk-adapted allocation of conditioning intensity based on GA 3. GA-directed, longitudinal supportive care management
- interventionNames
- Other: Geriatric assessment (GA) pre-transplant
- Drug: conditioning regimen
- Procedure: Allogeneic CD34+ selected stem cells
Primary outcomes (1)
- measure
- cumulative incidence of non-relapse mortality (NRM)
- timeFrame
- 1 year
- description
- defined as death in the absence of relapse/disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * are 60 years or older * have a pathologically confirmed myeloid malignancies including acute myeloid leukemia, ,myelodysplastic syndrome, myeloproliferative neoplasms, or related blood disorders including chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, and myelodysplastic/myeloproliferative overlapping syndrome * have \<10% blasts in bone marrow prior to transplant * have a matched related or unrelated donor, mismatched unrelated donor, or haploidentical donor * Meet institutional standard criteria for allogeneic transplantation as determined by the primary transplant physician * Undergoes transplantation using the allocated conditioning regimen intensity defined by the protocol-specified criteria below: * HCT-CI/Age \<5 and IADL normal = myeloablative regimen * HCT-CI/Age ≥5 and/or IADL impairment = RIC/NMA regimen Exclusion Criteria: * Prior hematopoietic cell transplantation * Cord blood donors * Persons with active, refractory disease defined by ≥10% blasts in bone marrow prior to transplant
References
Publications (0)
Data not yet available