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

Phase 2

Active, not recruiting

• Conditions: Myelodysplastic Syndrome; Myeloproliferative Neoplasms; Chronic Myelomonocytic Leukemia; Atypical Chronic Myeloid Leukemia; Myelodysplastic/Myeloproliferative Overlapping Syndrome
• Interventions: Other: Geriatric assessment (GA) pre-transplant; Drug: conditioning regimen; Procedure: Allogeneic CD34+ selected stem cells

• Registration Number: NCT04761770
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

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)

Study Timeline

• Study Start: 2021-02-15
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Geriatric participants with various blood disorders	Geriatric assessment (GA) pre-transplant	1. Geriatric assessment (GA) pre-transplant 2. Risk-adapted allocation of conditioning intensity based on GA 3. GA-directed, longitudinal supportive care management
Geriatric participants with various blood disorders	conditioning regimen	1. Geriatric assessment (GA) pre-transplant 2. Risk-adapted allocation of conditioning intensity based on GA 3. GA-directed, longitudinal supportive care management
Geriatric participants with various blood disorders	Allogeneic CD34+ selected stem cells	1. Geriatric assessment (GA) pre-transplant 2. Risk-adapted allocation of conditioning intensity based on GA 3. GA-directed, longitudinal supportive care management

Primary Outcome Measures

Name	Time	Method
cumulative incidence of non-relapse mortality (NRM)	1 year	defined as death in the absence of relapse/disease progression.

Trial Locations

Locations (7)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Monmouth (Consent Only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Commack (Consent only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Bergen (Consent Only); 🇺🇸 Montvale, New Jersey, United States

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

Memorial Sloan Kettering Westchester (Consent Only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (Consent Only); 🇺🇸 Uniondale, New York, United States