Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Roswell Park Comprehensive Cancer Center

Status: Enrolling

Conditions: Hematopoietic and Lymphoid System Neoplasm

Treatments: Procedure: Biospecimen Collection; Procedure: Dual X-ray Absorptiometry; Procedure: Low Intensity Vibration Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05893940

I-3434822

Details and patient eligibility

About

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.

Full 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

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

LIMS vibration Therapy, DEXA Scan - Cohort 1

Experimental group

Description:

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

Treatment:

Procedure: Low Intensity Vibration Therapy

Procedure: Dual X-ray Absorptiometry

Procedure: Biospecimen Collection

LIMS vibration therapy - Cohort II

Experimental group

Description:

Patients undergo LIMS vibration therapy over 10-minutes BID for 14 days on study. Patients also undergo blood sample collection throughout the trial.

Treatment:

Procedure: Low Intensity Vibration Therapy

Procedure: Biospecimen Collection