Hematologic Malignancy Clinical Trial
Official title:
Digital Multi-Vital Sign Monitoring for Early Detection of Cytokine Release Syndrome From Bispecific T-Cell Engagers and Chimeric Antigen Receptor Therapy
Verified date | May 2024 |
Source | Duke University |
Contact | Lauren Hill |
Phone | 7045774113 |
lauren9494[@]gmail.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate two vital sign monitoring devices, TempTraq and VitalTraq, in patients with hematologic malignancies undergoing therapy with Chimeric antigen receptor T-cell therapy (CAR-T) or Bispecific T-cell engagers (BiTE) products. TempTraq is an axillary patch that is worn on the skin and continuously monitors a patient's body temperature. VitalTraq is a smartphone application that utilizes remote photoplethysmography technology via a 30-second facial scan to estimate the patient's blood pressure (BP), heart rate (HR), heart rate variability (HRV), and respiratory rate. These remote vital sign monitoring devices have the potential to promote earlier detection and intervention of treatment-related toxicities, including cytokine release syndrome (CRS) and febrile neutropenia.
Status | Not yet recruiting |
Enrollment | 32 |
Est. completion date | December 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adults at or over the age of 18 with hematologic malignancies undergoing treatment with chimeric antigen receptor (CAR) T-cell therapy or bispecific T-cell engagers (BiTE), as follows: - Axicabtagene ciloleucel - Lisocabtagene maraleucel - Brexucabtagene autoleucel - Idecabtagene vicleucel - Ciltacabtagene autoleucel - Tisagenlecleucel - Blinatumomab - Mosunetuzumab - Talquetamab - Elranatamab - Teclistamab - Glofitamab 2. Owns a smart phone (e.g., iPhone, Android, Samsung) that is compatible with the VitalTraq app and that can connect to wi-fi. This will be assessed at screening. 3. Able to read and understand English 4. Willing and able to provide informed consent to the study Exclusion Criteria: 1. Receiving a non-FDA approved CAR-T or BiTE product 2. Receiving Epcoritamab |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Duke University | Blue Spark Technologies |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TempTraq's ability to measure axillary temperature in the intended use population. | Body temperature (degrees Celsius) data will be measured as a continuous variable via the TempTraq device and via standard-of-care oral thermometers. | Day 14 | |
Secondary | Lead time by which fevers can be detected using TempTraq compared to SOC interval oral thermometer measurements. | The times to first detection of fever, if applicable, will be measured for each patient using temperature data derived from the TempTraq device and standard-of-care oral thermometers. The mean time to first fever (i.e., temperature > 38 degrees Celsius), will be calculated and described for both the TempTraq device and standard-of-care oral thermometers. | Day 14 | |
Secondary | VitalTraq's ability to measure blood pressure in the intended use population. | Determined by use of an equivalence test to test the hypothesis that there is no difference in the systolic and diastolic measurements using VitalTraq compared to SOC interval vitals measurements. The smallest tolerable differences in systolic and diastolic blood pressure are set to be 20 mmHg and 10 mmHg, respectively. | Day 14 | |
Secondary | VitalTraq's ability to measure heart rate in the intended use population. | Determined by use of an equivalence test to test the hypothesis that there is no difference in the heart rate measurements using VitalTraq compared to SOC interval oral thermometer measurements. The smallest tolerable difference is set to be 10 beats per minute. | Day 14 | |
Secondary | Patient's perspective on the burden of using TempTraq and VitalTraq. | The mean scores on individual questions in a post-intervention survey featuring 7-point Likert scale responses, where 1=strongly agree and 7=strongly disagree, will be calculated and described. A lower score indicates lower burden. | Day 28 | |
Secondary | Lead time by which TempTraq and VitalTraq can detect grade 2 or higher Cytokine Release Syndrome (CRS) as compared to the standard of care. | The times to first detection of grade 2 or higher CRS, if applicable, will be measured for each patient using vitals data derived from the TempTraq and VitalTraq devices, as well as via standard-of-care vitals measurements. The mean time to first detection of grade 2 or higher CRS will be calculated and described for both the investigational devices and standard-of-care monitoring. | Day 14 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Recruiting |
NCT04889937 -
Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population
|
||
Not yet recruiting |
NCT05820126 -
Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial
|
Phase 2 | |
Active, not recruiting |
NCT04509765 -
A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT
|
N/A | |
Not yet recruiting |
NCT06350994 -
Early Assessment of Cardiac Function After Treatment With CAR-T Cells
|
||
Withdrawn |
NCT04282174 -
CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies
|
Phase 2 | |
Not yet recruiting |
NCT05443854 -
Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)
|
Phase 3 | |
Withdrawn |
NCT03986086 -
MPH966 for Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
|
Phase 1/Phase 2 | |
Completed |
NCT02512666 -
Non Invasive Optical Imaging of WBC Count
|
N/A | |
Not yet recruiting |
NCT02193399 -
Physiotherapy in Hematopoietic Stem Cell Transplantation
|
N/A | |
Withdrawn |
NCT02207764 -
Reiki as a Complementary Therapy: A Pilot Study
|
N/A | |
Terminated |
NCT01846429 -
Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
|
Phase 1 | |
Terminated |
NCT01215981 -
Influenza Vaccine Post Allogeneic Transplant
|
N/A | |
Completed |
NCT00333190 -
CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation
|
N/A | |
Withdrawn |
NCT04392128 -
Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE)
|
Phase 2 | |
Recruiting |
NCT06102213 -
Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation
|
Phase 2 | |
Active, not recruiting |
NCT04552288 -
Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies
|
Phase 2 | |
Completed |
NCT03654404 -
A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients
|
N/A | |
Recruiting |
NCT05384288 -
Response to Influenza Vaccination in Pediatric Oncology Patients
|
||
Recruiting |
NCT05084027 -
Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT
|
Phase 2 |