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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Myeloproliferative Neoplasms; Myelodysplastic/Myeloproliferative Overlapping Syndrome; Atypical Chronic Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04761770

20-522

Details and patient eligibility

About

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.

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.

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)

Enrollment: 33 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Geriatric participants with various blood disorders

Experimental group

Description:

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

Treatment:

Procedure: Allogeneic CD34+ selected stem cells

Drug: conditioning regimen

Other: Geriatric assessment (GA) pre-transplant