Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Overview

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

Interventions

• Procedure Low Intensity Vibration Therapy
  Undergo LIMS vibration therapy
• Procedure Dual X-ray Absorptiometry
  Undergo DEXA scan
• Procedure Biospecimen Collection
  Undergo blood sample collection

Primary outcome measures

• time spent on LIMS - Cohort I [Time frame: Up to 120 days post hematopoietic cell transplantation (HCT)]
• Chimeric antigen receptor (CAR) T-cell product efficacy - Cohort II [Time frame: up to 120 days post hematopoietic cell transplantation]

Secondary outcome measures (4)

• Change in lumbar spine bone mineral density (BMD) - Cohort 1 [Time frame: Up to 120 days post - HCT]
• Change in femur BMD - Cohort 1 [Time frame: UP to 120 days post - HCT]
• Barriers to LIMS- Cohort 1 [Time frame: Up to 120 post -HCT]
• Change in patient reported outcomes - Cohort 1 [Time frame: Pre HCT and at time of second DEXA: day +80]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Roswell Park Comprehensive Cancer Center — Buffalo

Identifiers

NCT: NCT05893940 · I-3434822

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗