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Bone Marrow Transplant for Blood Cancers in Older Adults (REBOUND Trial)

N/A

Waitlist Available

Led By Philip Imus, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥60 years

Undergoing allogeneic bone marrow transplant at Johns Hopkins Hospital, the indication for which is a hematologic malignancy

Must not have

Unwillingness or inability to return at 6 months after transplantation for repeated evaluation

Non-English-speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-bmt, day 30, day 56 and day 180 post transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if there are physical or psychological traits that make people over 60 more likely to respond positively to a bone marrow transplant.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, bone marrow transplant procedures can generally involve risks like infection, graft-versus-host disease (where donated cells attack your body), bleeding complications, and organ damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

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

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I can walk on my own without help from others.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-bmt, day 30, day 56 and day 180 post transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-bmt, day 30, day 56 and day 180 post transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-bmt, day 30, day 56 and day 180 post transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Borg Rating of Perceived Exertion Scale score

Change in Frailty as assessed by the Frailty Phenotype instrument

Change in Physical Performance as assessed by Short Physical Performance Battery (SPPB)

+36 more

Side effects data

From 2021 Phase 2 trial • 10 Patients • NCT02757885

67%

Fever

67%

Graft-versus-host disease (GVHD)

50%

Epstein-Barr virus (EBV)

50%

Bacteriemia

33%

Central Nervous System Toxicity

17%

Non-engraftment

17%

Thrombotic microangiopathy (TMA)

17%

Cytomegalovirus infection (CMV)

17%

BK virus (BKV)

17%

Deep vein thrombosis (DVT)

100%

80%

60%

40%

20%

Study treatment Arm

Bone Marrow Recipient

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Interventional Arm- Bone Marrow TransplantExperimental Treatment1 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

0 / 5Eligibility criteria met