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ACTIVE NOT RECRUITING
NCT04761770
PHASE2

Study of a Geriatric Assessment to Plan a Treatment Approach for Older People With Various Blood Disorders

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

Official title: Phase II Study of a Geriatric Assessment-Driven, Risk-Adapted Allogeneic Hematopoietic Cell Transplant Strategy for Older Patients With Myeloid Malignancies

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2021-02-15

Completion Date

2027-02

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

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.

Locations (7)

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, United States