Acute Myeloid Leukemia Clinical Trial
Study of a Geriatric Assessment to Plan a Treatment Approach for Older People With Various Blood Disorders
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.
Full 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.
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)
Eligibility Criteria
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
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There are 7 Locations for this study
Basking Ridge New Jersey, 07920, United States More Info
Middletown New Jersey, 07748, United States More Info
Harrison New York, 10604, United States More Info
New York New York, 10065, United States More Info
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