Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

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

NCT ID: NCT05893940

Condition: Hematopoietic and Lymphoid System Neoplasm

Conditions: Official terms:
Hematologic Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Low Intensity Vibration Therapy
Description: Undergo LIMS vibration therapy
Arm group label: LIMS vibration Therapy, DEXA Scan - Cohort 1
Arm group label: LIMS vibration therapy - Cohort II

Other name: LIV

Other name: Low Intensity Virbration

Intervention type: Procedure
Intervention name: Dual X-ray Absorptiometry
Description: Undergo DEXA scan
Arm group label: LIMS vibration Therapy, DEXA Scan - Cohort 1

Other name: BMD scan

Other name: bone mineral density scan

Other name: DEXA

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo blood sample collection
Arm group label: LIMS vibration Therapy, DEXA Scan - Cohort 1
Arm group label: LIMS vibration therapy - Cohort II

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

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Roswell Park Comprehensive Cancer Center

Address:
City: Buffalo
Zip: 14263
Country: United States

Status: Recruiting

Contact:
Last name: Megan Herr, MD

Phone: 877-275-7724
Email: askroswell@roswellpark.org

Start date: August 14, 2023

Completion date: September 1, 2026

Lead sponsor:
Agency: Roswell Park Cancer Institute
Agency class: Other

Source: Roswell Park Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05893940