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Active, not recruitingNCT04761770Updated Feb 17, 2026

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

A Phase 2 interventional study of Geriatric assessment (GA) pre-transplant and conditioning regimen in Myelodysplastic Syndrome, Myeloproliferative Neoplasms and Chronic Myelomonocytic Leukemia, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 7 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
60 Years and older
Sex
All
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Study 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.

Read the 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/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)
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Conditions studied

  • Myelodysplastic Syndrome
  • Myeloproliferative Neoplasms
  • Chronic Myelomonocytic Leukemia
  • Atypical Chronic Myeloid Leukemia
  • Myelodysplastic/Myeloproliferative Overlapping Syndrome

Keywords

  • blood disorders
  • Allogeneic Hematopoietic Cell Transplant
  • 20-522
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In context

Myelodysplastic Syndromes

2,124 studies on the registry are indexed under Myelodysplastic Syndromes; 320 are open to participants now.

This study's enrollment of 33 is below the median of 39 across 1,740 interventional studies indexed under Myelodysplastic Syndromes.

Browse Myelodysplastic Syndromes studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Geriatric participants with various blood disorders

    1. Geriatric assessment (GA) pre-transplant 2. Risk-adapted allocation of conditioning intensity based on GA 3. GA-directed, longitudinal supportive care management

    Other: Geriatric assessment (GA) pre-transplant · Drug: conditioning regimen · Procedure: Allogeneic CD34+ selected stem cells

Interventions

  • OtherGeriatric assessment (GA) pre-transplant

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

  • Drugconditioning regimen

    Based on the Geriatric assessment. 1. HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -\> Myeloablative (MA) regimen 2. HCT-CI/Age \>4 AND/OR any IADL impairment (more vulnerable) -\> Reduced-intensity (RIC)/Nonmyeloablative (NMA) regimen

  • ProcedureAllogeneic CD34+ selected stem cells

    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.

06

What researchers measure

Primary outcomes

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

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

    Time frame: 1 year

07

Study locations

7 sites
  • 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
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References and documents

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04761770
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Feb 21, 2021
Start date
Feb 15, 2021
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Feb 17, 2026

Study contacts

Richard J Lin, MD, PhD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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