Resiliency in Older Adults Undergoing Bone Marrow Transplant

NCT ID: NCT04188678

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-28
• Study Completion Date: 2025-09-30

Brief Summary

The objective of this research is to measure certain indicators of resiliency to better understand which participants who are over 60 years old will respond more positively to bone marrow transplant. This research is being done to determine if there are traits that make recipients more likely to bounce back following allogeneic bone marrow transplant (BMT).

Detailed Description

Allogeneic blood and marrow transplantation (alloBMT) is the only potentially curative therapy for many forms of leukemia, lymphoma, and other hematologic malignancies. As with many forms of cancer, many of the most common indications for alloBMT disproportionally affect older people. Although treatments have improved for older adults undergoing therapies for these diseases, the outcomes are variable and there is little biological knowledge to help identify specific factors that would predict why some people do well with treatment and others develop functional and cognitive decline and other adverse health outcomes.

Data specific to patients older than 60 who have undergone alloBMT are sparse even though the 1 year non-relapse mortality rate in patients older than age 50 at Johns Hopkins is 12%. In none of these studies have geriatric assessment measures in domains such as cognition and function been evaluated. Given the low incidence of non-relapse mortality in the investigators' older patients, the investigators have a unique opportunity to study the factors that influence not only mortality but function after hematopoietic stem cell transplantation. The investigators aim to be able to counsel patients more specifically about likely outcomes after transplant.

Conditions

Leukemia; Lymphoma; Blood Cancer; Myelodysplastic Syndrome; Acute Myelogenous Leukemia; Non-Hodgkins Lymphoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Interventional Arm- Bone Marrow Transplant

Study visits will include the performance of assessments prior to the start of conditioning chemotherapy and at 1 month and 6 months post-BMT. Assessments include:

1. Physical function assessments

2. questionnaires about general health and current health compared to health one year ago

3. assessments that measure cognition, attention and memory

4. assessments regarding personality and psychological and social stressors

5. Physiological measures including

• blood tests- 160 mL of blood during evaluations, and 90mL of blood at the day 180 visit.
• bone marrow aspirate collected during standard of care bone marrow biopsies pre-transplant and at day 180
• Saliva collections pre-transplant
• ACTH Stimulation Test
• Oral Glucose Tolerance Test
• Holter Monitor- to record hear rate variability
• MRI pre-transplant and at Day 180 in a subset of 10 subjects

Bone Marrow Transplant (BMT)

Intervention Type: OTHER

Bone marrow transplantation will be conducted according to the investigators' institution's standard of care, or else according to research protocol (if applicable).Study visits that include the performance of assessments will occur prior to the start of conditioning chemotherapy and at 1 month and 6 months post-BMT. All dates are +/- 7 days. The initial study visit will take place during standard of care pre-transplant evaluations, which typically span 3-4 days. The post-BMT visits will take place before or after regularly-scheduled BMT follow up.

Interventions

Bone Marrow Transplant (BMT)

Bone marrow transplantation will be conducted according to the investigators' institution's standard of care, or else according to research protocol (if applicable).Study visits that include the performance of assessments will occur prior to the start of conditioning chemotherapy and at 1 month and 6 months post-BMT. All dates are +/- 7 days. The initial study visit will take place during standard of care pre-transplant evaluations, which typically span 3-4 days. The post-BMT visits will take place before or after regularly-scheduled BMT follow up.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Undergoing allogeneic bone marrow transplant at Johns Hopkins Hospital, the indication for which is a hematologic malignancy
• Age ≥60 years
• Ability to walk without human assistance
• Enrollment in concomitant clinical research is permitted but not required
• English-speaking
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Unwillingness or inability to return at 6 months after transplantation for repeated evaluation
• Non-English-speaking

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Imus, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UH2AG056933

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00165139

Identifier Type: OTHER

Identifier Source: secondary_id

J1849

Identifier Type: -

Identifier Source: org_study_id