Study of a Geriatric Assessment to Plan a Treatment Approach for Older People With Various Blood Disorders
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT04761770
This phase II study assesses a personalized allo-HCT strategy for older patients with myeloid malignancies, using geriatric assessment to guide treatment intensity. Eligibility includes age 60+, specific blood disorders, and donor availability. Interventions involve pre-transplant geriatric assessment and conditioning regimens based on vulnerability, with MA for fit and RIC/NMA for more vulnerable patients.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
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.
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HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -> MA regimen
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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)
Eligibility Criteria
Inclusion Criteria
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are 60 years or older
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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
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have <10% blasts in bone marrow prior to transplant
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have a matched related or unrelated donor, mismatched unrelated donor, or haploidentical donor
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Meet institutional standard criteria for allogeneic transplantation as determined by the primary transplant physician
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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
Exclusion Criteria
- Prior hematopoietic cell transplantation
- Cord blood donors
- Persons with active, refractory disease defined by ≥10% blasts in bone marrow prior to transplant
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent Only) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Consent Only) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Consent Only) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Commack (Consent only) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Consent Only) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Consent Only) | 11553 | Uniondale | New York |
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