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

Myelodysplastic Syndrome Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Atypical Chronic Myeloid Leukemia
• Chronic Myelomonocytic Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myelomonocytic, Juvenile
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Overlapping Syndrome
• Myeloproliferative Disorders
• Myeloproliferative Neoplasms
• Syndrome

• NCT number: NCT04761770
• Study type: Interventional
• Source: Memorial Sloan Kettering Cancer Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 15, 2021
• Completion date: February 2025