Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Not Applicable

Recruiting

• Conditions: Hematopoietic and Lymphoid System Neoplasm

• Registration Number: NCT05893940
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-06-08
• Study Start: 2023-08-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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.)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in lumbar spine bone mineral density (BMD) - Cohort 1	Up to 120 days post - HCT	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.
Change in femur BMD - Cohort 1	UP to 120 days post - HCT	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.
Barriers to LIMS- Cohort 1	Up to 120 post -HCT	Reasons why LIMS was not used
Change in patient reported outcomes - Cohort 1	Pre HCT and at time of second DEXA: day +80	Short form 36 will be used to assess physical activities - comprising of 36 questions with ranges from 0 (worst) to 100 (Best)

Trial Locations

Locations (1)

Roswell Park Comprehensive Cancer Center; 🇺🇸 Buffalo, New York, United States