Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Hematopoietic and Lymphoid System Neoplasm Clinical Trial

Official title:

Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893940
• Other study ID #: I-3434822
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: December 2023
• Source: Roswell Park Cancer Institute
• Contact: Megan Herr, MD
• Phone: 716-845-3557
• Email: Megan.Herr[@]roswellpark.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic and Lymphoid System Neoplasm

Intervention

Procedure:
• Low Intensity Vibration Therapy
Undergo LIMS vibration therapy
• Dual X-ray Absorptiometry
Undergo DEXA scan
• Biospecimen Collection
Undergo blood sample collection

Locations

Country	Name	City	State
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time spent on LIMS - Cohort I	Will assess how much time and days use throughout study period	Up to 120 days post hematopoietic cell transplantation (HCT)
Primary	Chimeric antigen receptor (CAR) T-cell product efficacy - Cohort II	Blood samples will be collected for CAR-T cell efficacy before and after LIMS sessions	up to 120 days post hematopoietic cell transplantation
Secondary	Change in lumbar spine bone mineral density (BMD) - Cohort 1	dual x-ray absorptiometry (DEXA) scans conducted as standard of care. BMD pre-HCT and post-HCT of patients who received LIMS compared to those who did not. A Linear regression used to compare the changes.	Up to 120 days post - HCT
Secondary	Change in femur BMD - Cohort 1	Assessed using DEXA scans conducted as standard of care. BMD pre-HCT and post-HCT of patients who received LIMS will be compared to those who did not. A linear regression used to compare the changes.	UP to 120 days post - HCT
Secondary	Barriers to LIMS- Cohort 1	Reasons why LIMS was not used	Up to 120 post -HCT
Secondary	Change in patient reported outcomes - Cohort 1	Short form 36 will be used to assess physical activities - comprising of 36 questions with ranges from 0 (worst) to 100 (Best)	Pre HCT and at time of second DEXA: day +80