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
1. Chemotherapies: busulfan, fludarabine, melphalan, cyclophosphamide, thiotepa, clofarabine
2. Radiation therapy: total body irradiation (TBI)
3. Other therapy: anti-thymocyte globulin (ATG)

SparkCures ID	1257
Trial Phase	Phase 2
Enrollment	33 Patients
Treatments	Allogeneic Stem Cell Transplant
Tags	Allogeneic Stem Cell Transplant Chemotherapy Myeloablative Conditioning (MAC) Nonmyeloablative Conditioning (NMA) Pre-Transplant Reduced Intensity Conditioning (RIC)
Trial Sponsors	Memorial Sloan Kettering Cancer Center
NCT Identifier	NCT04761770

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

Study of a Geriatric Assessment to Plan a Treatment Approach for Older People With Various Blood Disorders

Overview

Am I Eligible?

US Trial Locations