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NCT Number: NCT04761770

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Myelodysplastic Syndrome Atypical Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Chronic Myelomonocytic Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Overlapping Syndrome Myeloproliferative Disorders Myeloproliferative Neoplasms Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (Consent Only), Basking Ridge, New Jersey, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Geriatric assessment (GA) pre-transplant

Other

Assessment of comorbidities, polypharmacy, and functional, nutritional, and psychosocial impairment.

Conditioning Regimen

Drug

Based on the Geriatric assessment.

  • HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -> Myeloablative (MA) regimen
  • HCT-CI/Age >4 AND/OR any IADL impairment (more vulnerable) -> Reduced-intensity (RIC)/Nonmyeloablative (NMA) regimen

Allogeneic CD34+ selected stem cells

Procedure

Stem cells are collected as per institutional guidelines. CD34+ enriched stem cells will be obtained using the FDA approved reagents from Miltenyi, according to the instruction manual.

Primary outcomes

  1. cumulative incidence of non-relapse mortality (NRM)

    Time frame: 1 year

    defined as death in the absence of relapse/disease progression.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Phase II Study of a Geriatric Assessment-Driven, Risk-Adapted Allogeneic Hematopoietic Cell Transplant Strategy for Older Patients With Myeloid Malignancies

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Feb 21, 2021
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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