Spots Global Cancer Trial Database for Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

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Trial Identification

Brief Title: Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Official Title: Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Study ID: NCT05893940

Conditions

Hematopoietic and Lymphoid System Neoplasm

Interventions

Low Intensity Vibration Therapy

Dual X-ray Absorptiometry

Biospecimen Collection

Study Description

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