Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients
NCT05893940
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.
Eligibility
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
Conditions2
Locations1 site
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NCT05893940