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Recruiting NCT05893940

Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Conditions: Hematopoietic and Lymphoid System Neoplasm

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 75
Sponsor: Roswell Park Cancer Institute

Location: Roswell Park Comprehensive Cancer Center Buffalo New York

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 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05893940). StuddyBuddy aggregates publicly available trial information.