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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04761770

Collaborator

(none)

Enrollment

Locations

Arm

35.5

Anticipated Duration (Months)

4.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome Myeloproliferative Neoplasms Chronic Myelomonocytic Leukemia Atypical Chronic Myeloid Leukemia Myelodysplastic/Myeloproliferative Overlapping Syndrome	Other: Geriatric assessment (GA) pre-transplant Drug: conditioning regimen Procedure: Allogeneic CD34+ selected stem cells	Phase 2

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.

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)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 15, 2021

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Geriatric participants with various blood disorders Geriatric assessment (GA) pre-transplant Risk-adapted allocation of conditioning intensity based on GA GA-directed, longitudinal supportive care management	Other: Geriatric assessment (GA) pre-transplant Assessment of comorbidities, polypharmacy, and functional, nutritional, and psychosocial impairment. Drug: conditioning regimen 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 Procedure: 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.

Arm

Intervention/Treatment

Experimental: Geriatric participants with various blood disorders

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

Other: Geriatric assessment (GA) pre-transplant

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

Drug: conditioning regimen

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

Procedure: 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Exclusion Criteria:

Prior hematopoietic cell transplantation
Cord blood donors
Persons with active, refractory disease defined by ≥10% blasts in bone marrow prior to transplant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge (Consent Only)	Basking Ridge	New Jersey	United States	07920
2	Memoral Sloan Kettering Monmouth (Consent Only)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Consent Only)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Commack (Consent only)	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (Consent Only)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (Consent Only)	Uniondale	New York	United States	11553