Overview
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.
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
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.)
- Currently treated with a therapeutic dose of anti-coagulation for 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.)
- Currently treated with a therapeutic dose of anti-coagulation
- 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