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

Study Overview
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Brief Summary
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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
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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. HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -> MA regimen 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)

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

Conditions
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Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Chronic Myelomonocytic Leukemia, Atypical Chronic Myeloid Leukemia, Myelodysplastic/Myeloproliferative Overlapping Syndrome

Intervention / Treatment
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* Other: Geriatric assessment (GA) pre-transplant
* Drug: conditioning regimen
* Procedure: Allogeneic CD34+ selected stem cells


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Prior hematopoietic cell transplantation Cord blood donors Persons with active, refractory disease defined by ≥10% blasts in bone marrow prior to transplant

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, single center, phase II pilot treatment-allocation study at MSK for older patients considering allogeneic hematopoietic cell transplantation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Geriatric participants with various blood disorders<br>Geriatric assessment (GA) pre-transplant Risk-adapted allocation of conditioning intensity based on GA GA-directed, longitudinal supportive care management | Other: Geriatric assessment (GA) pre-transplant<br>* Assessment of comorbidities, polypharmacy, and functional, nutritional, and psychosocial impairment.<br>Drug: conditioning regimen<br>* Based on the Geriatric assessment. HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -> Myeloablative (MA) regimen HCT-CI/Age >4 AND/OR any IADL impairment (more vulnerable) -> Reduced-intensity (RIC)/Nonmyeloablative (NMA) regimen<br>Procedure: Allogeneic CD34+ selected stem cells<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative incidence of non-relapse mortality (NRM) | defined as death in the absence of relapse/disease progression. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood disorders, Allogeneic Hematopoietic Cell Transplant, 20-522