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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIMS vibration Therapy, DEXA Scan - Cohort 1 | Experimental | Patients undergo LIMS vibration therapy over 10 minutes on study. Patients also undergo DEXA scan at follow up and may optionally undergo blood sample collection and questionnaire at baseline and follow up |
|
| LIMS vibration therapy - Cohort II | Experimental | Patients undergo LIMS vibration therapy over 10-minutes BID for 14 days on study. Patients also undergo blood sample collection throughout the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Intensity Vibration Therapy | Procedure | Undergo LIMS vibration therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in femur BMD - Cohort 1 |
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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:
COHORTII:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Herr, MD | Contact | 716-845-3557 | Megan.Herr@roswellpark.org |
| Name | Affiliation | Role |
|---|---|---|
| Megan Herr, MD | Roswell Park Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Comprehensive Cancer Center | Recruiting | Buffalo | New York | 14263 | United States |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Dual X-ray Absorptiometry | Procedure | Undergo DEXA scan |
|
|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
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 |
| Barriers to LIMS- Cohort 1 | Reasons why LIMS was not used | Up to 120 post -HCT |
| 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 |
| D003720 |
| Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |