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.

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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)

View Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

33

Study ID:

NCT04761770

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 7 Locations for this study

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Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale New Jersey, 07645, United States
Memorial Sloan Kettering Commack (Consent only)
Commack New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent Only)
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale New York, 11553, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

33

Study ID:

NCT04761770

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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