Phase II Study of a Geriatric Assessment-Driven, Risk-Adapted Allogeneic Hematopoietic Cell Transplant Strategy for Older Patients With Myeloid Malignancies
Overview
- Phase
- Phase 2
- Intervention
- Geriatric assessment (GA) pre-transplant
- Conditions
- Myelodysplastic Syndrome
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 33
- Locations
- 7
- Primary Endpoint
- cumulative incidence of non-relapse mortality (NRM)
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
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)
Investigators
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
- •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
Arms & Interventions
Geriatric participants with various blood disorders
1. Geriatric assessment (GA) pre-transplant 2. Risk-adapted allocation of conditioning intensity based on GA 3. GA-directed, longitudinal supportive care management
Intervention: Geriatric assessment (GA) pre-transplant
Geriatric participants with various blood disorders
1. Geriatric assessment (GA) pre-transplant 2. Risk-adapted allocation of conditioning intensity based on GA 3. GA-directed, longitudinal supportive care management
Intervention: conditioning regimen
Geriatric participants with various blood disorders
1. Geriatric assessment (GA) pre-transplant 2. Risk-adapted allocation of conditioning intensity based on GA 3. GA-directed, longitudinal supportive care management
Intervention: Allogeneic CD34+ selected stem cells
Outcomes
Primary Outcomes
cumulative incidence of non-relapse mortality (NRM)
Time Frame: 1 year
defined as death in the absence of relapse/disease progression.