Bone Marrow Transplant for Blood Cancers in Older Adults

(REBOUND Trial)

Overseen By Philip Imus, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Non-English-speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

126 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Bone Marrow Transplant (BMT) for blood cancers in older adults?

Research shows that older adults undergoing bone marrow transplants have similar or even better event-free survival rates compared to younger patients, with older patients having a 56% event-free survival rate over three years. This suggests that BMT can be an effective treatment option for older adults with blood cancers. ^{1 2 3 4 5}

Is bone marrow transplant safe for older adults with blood cancers?

Bone marrow transplants (BMT) in older adults have shown safety outcomes comparable to younger patients, with lower transplant-related complications in those over 40. However, there is a risk of complications like graft versus host disease (GVHD), which can be severe, and other issues such as infections and organ failure. ^{1 2 6 7 8}

How is bone marrow transplant different from other treatments for blood cancers in older adults?

Bone marrow transplant (BMT) is unique because it involves replacing damaged or destroyed bone marrow with healthy bone marrow stem cells, which can lead to long-term remission or cure in blood cancers. Unlike conventional chemotherapy, BMT can rescue patients from the toxic effects of intensive treatment and is particularly beneficial when performed early in the disease course. ^{1 5 9 10 11}

Research Team

Philip Imus, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for English-speaking individuals over 60 years old with leukemia, lymphoma, or other blood cancers who are able to walk unassisted and can sign a consent form. They must be getting an allogeneic bone marrow transplant at Johns Hopkins Hospital. Those unable to return for follow-up after 6 months cannot participate.

Inclusion Criteria

I am 60 years old or older.

You can participate in other studies while being part of this trial, but it is not mandatory.

I am scheduled for a bone marrow transplant at Johns Hopkins for blood cancer.

Exclusion Criteria

I cannot or will not return for a follow-up 6 months after my transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Transplant Assessment

Participants undergo various assessments including physical function, cognition, personality, and physiological measures before the start of conditioning chemotherapy

1-2 weeks

1 visit (in-person)

Conditioning Chemotherapy

Participants receive conditioning chemotherapy prior to bone marrow transplant

1 week

Bone Marrow Transplant

Participants undergo the bone marrow transplant procedure

1 day

Post-Transplant Monitoring

Participants are monitored weekly for changes in attention, physical performance, and other health indicators from Day of transplant to Day 60

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at Day 30, Day 56, and Day 180 post-transplant

6 months

3 visits (in-person)

Treatment Details

Interventions

• Bone Marrow Transplant (BMT)

Trial Overview The study aims to identify traits of resiliency in older adults undergoing bone marrow transplants by measuring certain indicators. It seeks to understand which patients are more likely to recover well from the procedure.

Participant Groups

Group I: Interventional Arm- Bone Marrow Transplant Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

References

1. Japan pubmed.ncbi.nlm.nih.gov

Relationships between hematological recovery and overall survival in older adults undergoing allogeneic bone marrow transplantation. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Patients > or = age 40 years undergoing autologous or allogeneic BMT have regimen-related mortality rates and event-free survivals comparable to patients [2006]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[How extensive are the present indications for bone marrow transplantation?]. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

Allogeneic marrow transplantation for acute nonlymphoblastic leukemia. [2016]

5. India pubmed.ncbi.nlm.nih.gov

Bone marrow transplant: A two-decade single centre hematology experience. [2023]

6. Japan pubmed.ncbi.nlm.nih.gov

[Outcomes of 50 leukemia patients who received bone marrow transplants from unrelated donors]. [2013]

7. Japan pubmed.ncbi.nlm.nih.gov

[Indication and results of bone marrow transplantation in acute leukemia]. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Secondary malignancies after bone marrow transplantation in adults. [2017]

9. Switzerland pubmed.ncbi.nlm.nih.gov

[Bone marrow transplantation]. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

Bone marrow transplantation in leukemia. Current status. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

[Indications, technique and risks in bone marrow transplantation in adulthood]. [2008]