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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to discover what makes older adults more resilient after a bone marrow transplant for blood cancers. Researchers seek to identify specific traits or factors that help people over 60 recover better from the procedure. The trial focuses on those already planning to have a bone marrow transplant at Johns Hopkins Hospital and who can move around without assistance. Participants will undergo various assessments, including physical and mental health checks, before and after the transplant.

As an unphased study, this trial offers participants the chance to contribute to groundbreaking research that could improve recovery outcomes for future patients.

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.

Is there any evidence suggesting that bone marrow transplant is likely to be safe for humans?

Research has shown that bone marrow transplants (BMT) are generally well-tolerated for treating blood cancers. Studies have found BMT to be a life-saving option for people with blood cancers like leukemia and lymphoma. Although complex, evidence supports the procedure's safety and effectiveness.

Patients have experienced a range of outcomes, but the procedure is generally safe. Like any serious medical procedure, BMT carries risks. Common side effects include fatigue and infections as the immune system recovers. However, advances in medical care now help manage these risks more effectively.

Anyone considering BMT should discuss the potential risks and benefits with their medical team. This ensures an informed decision based on the latest information and individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are exploring bone marrow transplants (BMT) for older adults with blood cancers because this treatment has the potential to offer a more effective option for those who may not tolerate standard treatments like chemotherapy or radiation. Unlike traditional methods, BMT involves replacing damaged or diseased bone marrow with healthy cells, which can lead to better recovery and less relapse. While standard treatments mainly target cancer cells directly, BMT aims to rejuvenate the body's ability to fight cancer by rebuilding a healthy immune system. This approach is particularly exciting as it might provide a viable treatment pathway for older patients who have limited options due to age-related health concerns.

What evidence suggests that bone marrow transplant might be an effective treatment for blood cancers in older adults?

Research has shown that bone marrow transplants (BMT) are a strong treatment option for blood cancers. In this trial, participants will receive BMT as the primary intervention. One study found that 83.8% to 78.6% of patients who received BMT were alive after one year, depending on treatment intensity. Another study demonstrated that BMT can extend life or even cure various blood-related cancers. Long-term data reveal that about 31.5% of some patients were still alive ten years after the transplant, highlighting the potential for lasting benefits. BMT is considered effective for treating many blood-related diseases, whether cancerous or not. ^{1 6 7 8 9}

Who Is on the Research Team?

Philip Imus, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. nmdp.org nmdp.org/what-we-do/news/press-releases/nmdp-trial-results-show-strong-outcome-for-adult-transplant-patients-in-journal-of-clinical-oncology

NMDP Trial Results Show Strong Outcomes for Adult ... The one-year OS was 83.8% for MAC and 78.6% for RIC/NMA recipients. These outcomes were comparable to, or better than, historical 8/8 matched ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4010196/

Hematopoietic Stem Cell Transplantation for Hematologic ... Hematopoietic cell transplantation (HCT) provides a life-prolonging or potentially curative treatment option for patients with hematologic malignancies.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2897903/

Favorable Outcomes in Patients Surviving 5 or More Years ... An early study of long-term SCT survivors reported an overall survival (OS) of 31.5% at 10 years in 89 chronic myeloid leukemia (CML) patients who had received ...

4. cancernetwork.com cancernetwork.com/view/ucbt-yields-excellent-efficacy-outcomes-in-hematologic-malignancies

UCBT Yields Excellent Efficacy Outcomes in Hematologic ... Among patients who were treated on the study (n = 132), the 2-year overall survival (OS) rate was 74% (95% CI, 65%-80%) in this population, with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01135329

Reduced-intensity, Related-donor Bone Marrow ... BMT has developed over several decades of research as an effective treatment of various malignant and nonmalignant hematologic diseases.

6. journals.lww.com journals.lww.com/md-cases/fulltext/2021/12000/efficacy_and_safety_of_hematopoietic_stem_cell.6.aspx

Efficacy and safety of hematopoietic stem cell... Efficacy and safety of hematopoietic stem cell transplantation for hematologic malignancies. A protocol for an overview of systematic reviews and meta- ...

7. hopkinsmedicine.org hopkinsmedicine.org/kimmel-cancer-center/research/hematologic-bone-marrow-transplant

Hematologic Malignancies and Bone Marrow Transplant Cancers of the blood and lymph or immune cells, such as leukemia, lymphoma, and multiple myeloma are the focus of the Hematologic Malignancies and Bone Marrow ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00796562

NCT00796562 | Safety Study of Bone Marrow Transplant ... The purpose of this study is to see if giving high dose chemotherapy and total body irradiation before and repeating high dose chemotherapy after a bone ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2666636723016408

Risks of Patient and Donor Genetics in Allogeneic ... Outcome data on donors in cases of DDM are limited [20]. In the EBMT registry data from 1982 to 2003, no malignancies in donors were reported among 14 DDM cases ...