low-intensity mechanical stimulation for hematologic malignancy patients

Conditions: Hematopoietic and Lymphoid System Neoplasm

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.

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

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