Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients
NCT ID: NCT05893940
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2023-08-14
2026-09-01
Brief Summary
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Detailed Description
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I. Determine the feasibility of delivering a low-intensity mechanical stimulation (LIMS) program immediately following hematopoietic cell transplantation (HCT). COHORT 1 II. II. Evaluate chimeric antigen receptors (CAR) T-cell product efficacy of Non-Hodgkin lymphoma (NHL) patients undergoing LIMS in comparison to patients not treated with LIMS. COHORT II
SECONDARY OBJECTIVE:
I. Determine the effect size of a LIMS program on bone marrow density (BMD) post-HCT.
COHORT 1 II. Evaluate the manufacturing parameters (product viability, total cell dose, transduction efficiency, time to produce the CAR T-cell product) pre- and post-LIMS. COHORT II
OUTLINE:
Patients are assigned to 1 of 2 cohorts.
COHORT 1 - Patients undergo LIMS vibration therapy over 10-minutes once a day on study. Treatment begins day -8 to -1 during admission for HCT and until day 180 using the LIMS board at home. Patients also undergo dual x-ray absorptiometry (DEXA) scan at follow up and may optionally undergo blood sample collection at baseline and follow up.
COHORT II: Patients undergo LIMS vibration therapy over 10-minutes twice daily (BID) for 14 days on study. Patients also undergo blood sample collection throughout the trial
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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LIMS vibration Therapy, DEXA Scan - Cohort 1
Patients undergo LIMS vibration therapy over 10 minutes on study. Patients also undergo DEXA scan at follow up and may optionally undergo blood sample collection and questionnaire at baseline and follow up
Low Intensity Vibration Therapy
Undergo LIMS vibration therapy
Dual X-ray Absorptiometry
Undergo DEXA scan
Biospecimen Collection
Undergo blood sample collection
LIMS vibration therapy - Cohort II
Patients undergo LIMS vibration therapy over 10-minutes BID for 14 days on study. Patients also undergo blood sample collection throughout the trial.
Low Intensity Vibration Therapy
Undergo LIMS vibration therapy
Biospecimen Collection
Undergo blood sample collection
Interventions
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Low Intensity Vibration Therapy
Undergo LIMS vibration therapy
Dual X-ray Absorptiometry
Undergo DEXA scan
Biospecimen Collection
Undergo blood sample collection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* COHORT I: Scheduled to undergo an autologous or allogeneic HCT
* COHORT 1: \>= 18 years of age
* COHORT 1: Patient must understand the investigational nature of this study and sign an institutional review board approved written informed consent form prior to receiving any study related procedure
\- COHORT II: ≥ 18 years of age
* COHORT II: Diagnosis of non-Hodgkin lymphoma (specifically diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia; patients with preexisting osteoporosis are eligible)
* COHORT II: Patient must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria
* Any prior allogeneic HCT
* Any prior autologous HCT for those patients who have a planned auto HCT
* Pre-transplant weight \>= 275 lbs. (max weight for the board)
* Body mass index (BMI) \< 18 kg/m\^2
* Recipient of cord blood transplant
* Multiple myeloma or amyloidosis diagnosis
* History of a central nervous system (CNS) hemorrhage \< 60 days
* History of any aneurysm (cerebral, aortic, etc.)
* A recent pulmonary embolism or deep vein thrombosis
* A cardiac pacemaker
* Prior history of non-traumatic (spontaneous) fracture
* Total joint replacement (any joint)
* History of kidney stones or gall stones within the last 2 years unless a cholecystectomy was performed
* Any prosthetic lower extremity or limb
* Pregnant or nursing female patients
* Unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study intervention
COHORTII:
* Planned CAR T-cell therapy within the next 2 months
* Prior CAR T-cell therapy
* Active treatment within the last 60 days
* Pre-transplant weight ≥ 275 lbs. (max weight for the board)
* BMI \< 18 kg/m\^2
* History of a CNS hemorrhage \< 60 days
* History of any aneurysm (cerebral, aortic, etc.)
* A recent pulmonary embolism or deep vein thrombosis
* A cardiac pacemaker
* Recent history (\< 60 days) of non-traumatic (spontaneous) fracture
* Recent surgery (\< 60 days)
* Pregnant or nursing female patients
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study intervention
18 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Megan Herr, MD
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Comprehensive Cancer Center
Locations
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Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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I-3434822
Identifier Type: -
Identifier Source: org_study_id
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