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
1 other identifier
interventional
33
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2021
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2021
CompletedFirst Submitted
Initial submission to the registry
February 16, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
February 17, 2026
February 1, 2026
6 years
February 16, 2021
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cumulative incidence of non-relapse mortality (NRM)
defined as death in the absence of relapse/disease progression.
1 year
Study Arms (1)
Geriatric participants with various blood disorders
EXPERIMENTAL1. Geriatric assessment (GA) pre-transplant 2. Risk-adapted allocation of conditioning intensity based on GA 3. GA-directed, longitudinal supportive care management
Interventions
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
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.
Assessment of comorbidities, polypharmacy, and functional, nutritional, and psychosocial impairment.
Eligibility Criteria
You may qualify if:
- 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
- Undergoes transplantation using the allocated conditioning regimen intensity defined by the protocol-specified criteria below:
- HCT-CI/Age \<5 and IADL normal = myeloablative regimen
- HCT-CI/Age ≥5 and/or IADL impairment = RIC/NMA regimen
You may not qualify if:
- Prior hematopoietic cell transplantation
- Cord blood donors
- Persons with active, refractory disease defined by ≥10% blasts in bone marrow prior to transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard J Lin, MD, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2021
First Posted
February 21, 2021
Study Start
February 15, 2021
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.