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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-bmt, day 30, day 56 and day 180 post transplant
Awards & highlights
REBOUND Trial 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.Check my eligibility
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.See study design
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.
REBOUND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
Select...
I am scheduled for a bone marrow transplant at Johns Hopkins for blood cancer.
Select...
I can walk on my own without help from others.
REBOUND Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSide effects data
From 2021 Phase 2 trial • 10 Patients • NCT0275788567%
Fever
67%
Graft-versus-host disease (GVHD)
50%
Bacteriemia
50%
Epstein-Barr virus (EBV)
33%
Central Nervous System Toxicity
17%
BK virus (BKV)
17%
Cytomegalovirus infection (CMV)
17%
Deep vein thrombosis (DVT)
17%
Non-engraftment
17%
Thrombotic microangiopathy (TMA)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bone Marrow Recipient
REBOUND 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:
Physical function assessments
questionnaires about general health and current health compared to health one year ago
assessments that measure cognition, attention and memory
assessments regarding personality and psychological and social stressors
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
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,770 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,668 Previous Clinical Trials
28,004,934 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,458 Total Patients Enrolled
1 Trials studying Blood Cancers
77 Patients Enrolled for Blood Cancers
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Eligibility Criteria:
This trial includes the following eligibility 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 cannot or will not return for a follow-up 6 months after my transplant.I do not speak English.I am scheduled for a bone marrow transplant at Johns Hopkins for blood cancer.I can walk on my own without help from others.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional Arm- Bone Marrow Transplant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this research endeavor currently available?
"Correct. The records on clinicaltrials.gov suggest that this research project, which was initially posted on September 28th 2018, is actively recruiting individuals to participate. Altogether they require 130 people at a single location."
Answered by AI
What is the present scope of this experiment's participants?
"Affirmative. Clinicaltrials.gov reveals that this experiment, first published on September 28th 2018, is still searching for participants. To date, 130 people are needed to join the study from a single location."
Answered by AI
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