Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Chronic Myelomonocytic Leukemia, Atypical Chronic Myeloid Leukemia, Myelodysplastic/Myeloproliferative Overlapping Syndrome
Conditions
Keywords
blood disorders, Allogeneic Hematopoietic Cell Transplant, 20-522
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.
Detailed 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. 1. HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -\> MA regimen 2. 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)
Interventions
OTHERGeriatric assessment (GA) pre-transplant
Assessment of comorbidities, polypharmacy, and functional, nutritional, and psychosocial impairment.
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
PROCEDUREAllogeneic CD34+ selected stem cells
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, single center, phase II pilot treatment-allocation study at MSK for older patients considering allogeneic hematopoietic cell transplantation.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cumulative incidence of non-relapse mortality (NRM) | 1 year | defined as death in the absence of relapse/disease progression. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRichard J Lin, MD, PhD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed