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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a prospective, single center, phase II pilot treatment-allocation study at MSK for older patients considering allogeneic hematopoietic cell transplantation.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Geriatric assessment (GA) pre-transplant

Intervention Type OTHER

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

conditioning regimen

Intervention Type DRUG

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

Allogeneic CD34+ selected stem cells

Intervention Type 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.

Interventions

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Geriatric assessment (GA) pre-transplant

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

Intervention Type OTHER

conditioning 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

Intervention Type DRUG

Allogeneic 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No