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

  • STATUS
    Recruiting
  • End date
    Feb 8, 2023
  • participants needed
    32
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 8 July 2022
chronic myeloid leukemia
myeloid leukemia
chronic myelomonocytic leukemia
leukemia
transplant conditioning
myelomonocytic leukemia

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.

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)

Details
Condition Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Chronic Myelomonocytic Leukemia, Atypical Chronic Myeloid Leukemia, Myelodysplastic/Myeloproliferative Overlapping Syndrome
Treatment Conditioning regimen, Geriatric assessment (GA) pre-transplant, Allogeneic CD34+ selected stem cells
Clinical Study IdentifierNCT04761770
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on8 July 2022

Eligibility

Yes No Not Sure

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

Exclusion Criteria

Prior hematopoietic cell transplantation
Cord blood donors
Persons with active, refractory disease defined by ≥10% blasts in bone marrow prior to transplant
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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