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

Myelodysplastic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04761770
• Other study ID #: 20-522
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 15, 2021
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atypical Chronic Myeloid Leukemia
• Chronic Myelomonocytic Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myelomonocytic, Juvenile
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Overlapping Syndrome
• Myeloproliferative Disorders
• Myeloproliferative Neoplasms
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent Only)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (Consent only)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent Only)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent Only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent Only)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent Only)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative incidence of non-relapse mortality (NRM)	defined as death in the absence of relapse/disease progression.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center