This phase II trial studies whether a geriatric assessment may be helpful in determining the best treatment approach in older patients (age 60+) with 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-HSCT). 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. Information from this study may help doctors better plan a treatment approach for older adults leading up to the stem cell transplant.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04761770.
PRIMARY OBJECTIVE:
I. To evaluate a geriatric assessment-driven, risk-adapted strategy for allogeneic hematopoietic cell transplantation in older patients with myeloid malignancies.
SECONDARY OBJECTIVES:
I. To estimate the 100-day cumulative incidence of non-relapse mortality (NRM).
II. To estimate the cumulative incidence of individual grade 3 or greater Common Terminology Criteria for Adverse Events (CTCAE) toxicities, both overall and by the baseline vulnerability criterion.
III. To estimate 1-year overall and relapse-free survival.
IV. To describe the quality of life using the total scores of The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) and European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), both overall and by the baseline vulnerability criterion.
V. To examine the uptake of geriatric assessment (GA)-directed, targeted supportive care management interventions.
EXPLORATORY OBJECTIVES:
I. To explore the association between NRM and individual pre-transplant geriatric impairments.
II. To explore the association of intestinal microbiota with the geriatric vulnerability criterion and transplant outcomes.
III. To explore the associations of senescence-associated inflamm-aging (pro-inflammatory cytokine milieu) with the geriatric vulnerability criterion and transplant outcomes.
IV. To explore the impact of pre-transplant (0-45 days) measurable residual disease (MRD) status on transplant outcomes.
OUTLINE:
Patients undergo geriatric assessment. Based on the results of the geriatric assessment, patients undergo conditioning regimen per the discretion of the treating physician. Conditioning regimens may include busulfan intravenously (IV) over 2 hours, melphalan, fludarabine IV, clofarabine IV over 2 hours, thiotepa, cyclophosphamide IV, and/or low dose total body irradiation. Patients undergo allo-HSCT on day 0. Patients undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 3, 6, and 12 months, and then annually for years 2-5.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorRichard Jirui Lin
