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.
Additional locations may be listed on ClinicalTrials.gov for NCT05893940.
Locations matching your search criteria
United States
New York
Buffalo
Roswell Park Cancer InstituteStatus: Active
Contact: Megan M Herr
Phone: 716-845-3557
PRIMARY OBJECTIVES:
I. Determine the feasibility of delivering a low-intensity mechanical stimulation (LIMS) program immediately following hematopoietic cell transplantation (HCT). (Cohort I)
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 OBJECTIVES:
I. Determine the effect size of a LIMS program on bone marrow density (BMD) post-HCT. (Cohort I)
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)
EXPLORATORY OBJECTIVE:
I. Assess cytokine profiles of CAR T-cell NHL patients undergoing LIMS. (Cohort II)
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients undergo LIMS vibration therapy over 10-minutes once daily (QD) 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.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorMegan M Herr
