NCT04761770

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective, phase II study evaluating the efficacy of a risk-adapted, personalized allo-HCT strategy based on geriatric vulnerabilities identified by pre-transplant GA. The less vulnerable/fit older patients are recommended to receive MA conditioning and the more vulnerable older patients are recommended to receive RIC/NMA conditioning. 1. HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -\> MA regimen 2. HCT-CI/Age \>4 AND/OR any IADL impairment (more vulnerable) -\> RIC/NMA regimen * Chemotherapies: busulfan, fludarabine, melphalan, cyclophosphamide, thiotepa, clofarabine * Radiation therapy: total body irradiation (TBI) * Other therapy: anti-thymocyte globulin (ATG)

Conditions

• Myelodysplastic Syndrome
• Myeloproliferative Neoplasms
• Chronic Myelomonocytic Leukemia
• Atypical Chronic Myeloid Leukemia
• Myelodysplastic/Myeloproliferative Overlapping Syndrome

Interventions

Type	Name	Description
OTHER	Geriatric assessment (GA) pre-transplant	Assessment of comorbidities, polypharmacy, and functional, nutritional, and psychosocial impairment.
DRUG	conditioning regimen	Based on the Geriatric assessment. 1. HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -\> Myeloablative (MA) regimen 2. HCT-CI/Age \>4 AND/OR any IADL impairment (more vulnerable) -\> Reduced-intensity (RIC)/Nonmyeloablative (NMA) regimen
PROCEDURE	Allogeneic CD34+ selected stem cells	Stem cells are collected as per institutional guidelines. CD34+ enriched stem cells will be obtained using the FDA approved reagents from Miltenyi, according to the instruction manual.

Timeline

• Start date: 2021-02-15
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2021-02-21
• Last updated: 2026-02-17

Locations

7 sites across 1 country: United States