Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Обзор

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.

Подробное описание

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

Вмешательства

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

Первичные конечные точки

• time spent on LIMS - Cohort I [Срок оценки: Up to 120 days post hematopoietic cell transplantation (HCT)]
• Chimeric antigen receptor (CAR) T-cell product efficacy - Cohort II [Срок оценки: up to 120 days post hematopoietic cell transplantation]

Вторичные конечные точки (4)

• Change in lumbar spine bone mineral density (BMD) - Cohort 1 [Срок оценки: Up to 120 days post - HCT]
• Change in femur BMD - Cohort 1 [Срок оценки: UP to 120 days post - HCT]
• Barriers to LIMS- Cohort 1 [Срок оценки: Up to 120 post -HCT]
• Change in patient reported outcomes - Cohort 1 [Срок оценки: Pre HCT and at time of second DEXA: day +80]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Roswell Park Comprehensive Cancer Center — Buffalo

Идентификаторы

NCT: NCT05893940 · I-3434822

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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