Status:
ACTIVE_NOT_RECRUITING
Study of a Geriatric Assessment to Plan a Treatment Approach for Older People With Various Blood Disorders
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Myelodysplastic Syndrome
Myeloproliferative Neoplasms
Eligibility:
All Genders
60+ years
Phase:
PHASE2
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 s...
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/...
Eligibility Criteria
Inclusion
- 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
- Prior hematopoietic cell transplantation
- Cord blood donors
- Persons with active, refractory disease defined by ≥10% blasts in bone marrow prior to transplant
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04761770
Start Date
February 15 2021
End Date
February 1 2026
Last Update
February 11 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States, 11725