Clinical trial NCT05893940: Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients
Official title: Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: time spent on LIMS - Cohort I
timeFrame: Up to 120 days post hematopoietic cell transplantation (HCT)
measure: Chimeric antigen receptor (CAR) T-cell product efficacy - Cohort II
timeFrame: up to 120 days post hematopoietic cell transplantation
Secondary outcomes:
measure: Change in lumbar spine bone mineral density (BMD) - Cohort 1
timeFrame: Up to 120 days post - HCT
measure: Change in femur BMD - Cohort 1
timeFrame: UP to 120 days post - HCT
measure: Barriers to LIMS- Cohort 1
timeFrame: Up to 120 post -HCT
measure: Change in patient reported outcomes - Cohort 1
timeFrame: Pre HCT and at time of second DEXA: day +80
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
Study officials:
affiliation: Roswell Park Comprehensive Cancer Center
name: Megan Herr, MD
role: PRINCIPAL_INVESTIGATOR
References: