Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

This clinical trial tests the effect of low-intensity mechanical stimulation (LIMS) vibration therapy in patients with hematologic malignancies. Patients with hematologic malignancies often undergo a blood and/or bone marrow transplant (hematopoietic cell transplantation [HCT]) or cellular therapy. The LIMS board delivers vibrations through the bones that may stimulate bone growth and may also increase muscle activity and strength and may also increase T-cell activation in patients planning to undergo cellular therapy. LIMS vibration therapy may stop or reverse BMD loss and/or improve the development of T-cells in the body in patients with hematologic malignancies who are undergoing or may plan to undergo HCT or cellular therapies.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid System Neoplasm
• Intervention / Treatment: Procedure: Biospecimen Collection; Procedure: Dual X-ray Absorptiometry; Procedure: Low Intensity Vibration Therapy

Detailed Description

PRIMARY OBJECTIVE:

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

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan Herr, MD; Phone Number: 716-845-3557; Email: Megan.Herr@roswellpark.org

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Park Comprehensive Cancer Center
      • Contact: Megan Herr, MD; Phone Number: 877-275-7724; Email: askroswell@roswellpark.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• COHORT I: Meet eligibility criteria for first autologous or allogeneic HCT (patients with preexisting osteoporosis are eligible)
• 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:

COHORT 1:

• 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.)
• Currently treated with a therapeutic dose of anti-coagulation for 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.)
• Currently treated with a therapeutic dose of anti-coagulation
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: Biospecimen Collection; Undergo blood sample collection; Procedure: Dual X-ray Absorptiometry; Undergo DEXA scan; Other Names: DEXA; BMD scan; bone mineral density scan; Procedure: Low Intensity Vibration Therapy; Undergo LIMS vibration therapy; Other Names: LIV; Low Intensity Virbration
Experimental: 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.	Procedure: Biospecimen Collection; Undergo blood sample collection; Procedure: Low Intensity Vibration Therapy; Undergo LIMS vibration therapy; Other Names: LIV; Low Intensity Virbration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time spent on LIMS - Cohort I	Will assess how much time and days use throughout study period	Up to 120 days post hematopoietic cell transplantation (HCT)
Chimeric antigen receptor (CAR) T-cell product efficacy - Cohort II	Blood samples will be collected for CAR-T cell efficacy before and after LIMS sessions	up to 120 days post hematopoietic cell transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lumbar spine bone mineral density (BMD) - Cohort 1	dual x-ray absorptiometry (DEXA) scans conducted as standard of care. BMD pre-HCT and post-HCT of patients who received LIMS compared to those who did not. A Linear regression used to compare the changes.	Up to 120 days post - HCT
Change in femur BMD - Cohort 1	Assessed using DEXA scans conducted as standard of care. BMD pre-HCT and post-HCT of patients who received LIMS will be compared to those who did not. A linear regression used to compare the changes.	UP to 120 days post - HCT
Barriers to LIMS- Cohort 1	Reasons why LIMS was not used	Up to 120 post -HCT
Change in patient reported outcomes - Cohort 1	Short form 36 will be used to assess physical activities - comprising of 36 questions with ranges from 0 (worst) to 100 (Best)	Pre HCT and at time of second DEXA: day +80

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Megan Herr, MD, Roswell Park Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: I-3434822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No