Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Heart and Blood Diseases

Rare Diseases

Leukemia

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Lymphosarcoma

Mantle Cell Lymphoma

Follicular Lymphoma

Acute Graft Versus Host Disease

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

All study participants will be enrolled in a 6-month digital health coaching program.

The digital health coaching program consists of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application. The program is 6-months in duration and designed for engagement following CAR T cell infusion.

Digital Health Coaching

Sherry Adkins, MSN

The aim of this study is to evaluate the feasibility of a digital health coaching program for, and to describe quality of life of, individuals in the 6 months following chimeric antigen receptor (CAR) T cell therapy. Up to 50 English-speaking individuals aged 18 and older who are to receive treatment with a CAR T cell therapy will be enrolled, all at The University of Texas MD Anderson Cancer Center. Participants must have internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments and will be excluded if they are unable to provide informed consent or have a prognosis of 6 months or less.

Consented participants will be enrolled in a 6-month digital health coaching program delivered via weekly calls from a Health Advisor coupled with the digital delivery of content. The program focuses on identification and escalation of treatment-related toxicity, communication with providers, and physical and psychosocial health following treatment. Health related quality of life (HRQoL) will be assessed with the Functional Assessment of Cancer Therapy-Lymphoma (FACT-L), health self-efficacy will be assessed by the Cancer Behavior Inventory-Brief (CBI-B), physical and mental health outcomes will be measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health 10. Patient experience in managing CAR T specific care will be assessed with a 5-item questionnaire developed specifically for use in this study, focused on participants' confidence in understanding, identifying and managing symptoms, and communicating with providers. Study outcomes will contribute to knowledge about if and how a digital health intervention may be used to support individuals post-CAR T cell therapy.

A single cohort of 50 individuals receiving chimeric antigen receptor T cell therapy will be enrolled in the study, all of which will be enrolled in a 6-month digital health coaching program. Individuals will be enrolled from a single site, The University of Texas MD Anderson Cancer Center.

Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy

Age, Race, Ethnicity, Sex at Birth, Gender Identity, Diagnosis, Treatment History, Co-morbid conditions

Frequency, types and duration of engagement with the digital health coaching platform

Feasibility is defined as a retention rate in the digital health coaching program greater than or equal to 60% at month 6

Acceptability will be assessed with a 3-item evaluation to address engagement, usefulness and relevance

This 12-item instrument measures self-efficacy in coping with cancer across 7 domains. These include: Seeking and Understanding Medical Information, Emotion Regulation, Coping with Treatment Related Side Effects, Accepting Cancer/ Maintaining a Positive Attitude, Seeking Social Support, and Using Spiritual Coping. The instrument utilizes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident".

The FACT-lym is a 42-item assessment that measures self-reported quality of life across 4 domains: physical, functional, emotional and social and includes 15 additional items validated specifically for individuals with lymphoma. The instrument can be scored as a whole as well as within the individual domains.

Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale is a ten item likert-scale survey that evaluates physical, social, and psychological well-being. The instrument consists of two scales, one for global physical health and one for global mental health.

a 5-item assessment of patients' experience in monitoring, managing, and reporting treatment related toxicities will be created specifically for use in this study and will mirror the response scale in the CBI-B. This includes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident". The following items will be included: 1) Understand the treatment toxicities I may experience while receiving CAR T-cell therapy; 2) Identify the signs and symptoms of these toxicities; 3) Communicate symptoms to provider; 4) Manage symptoms according to provider's instructions; 5) Explain treatment to a healthcare provider.

M.D. Anderson Cancer Center

Bristol-Myers Squibb

Pack Health

Behaviors and Mental Disorders

Lymphoma, Large B-Cell, Diffuse

Quality of Life

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Tisagenlecleucel

A single cohort of up to 100 individuals receiving chimeric antigen receptor T cell therapy will be enrolled in the study, all of whom will be enrolled in a 6-month digital health coaching program. Individuals will be enrolled at The Ohio State University Comprehensive Cancer Center.

Gretchen McNally, PhD

The aim of this non-interventional multi-center study is to evaluate quality of life (QOL) and other patient reported outcomes (PROs) among adults with diffuse large b-cell lymphoma (DLBCL) following Chimeric Antigen Receptor (CAR) T-cell therapy with tisagenlecleucel (Kymriah). Up to 100 individuals will be enrolled prior to tisagenlecleucel infusion in either the inpatient or ambulatory setting and followed for 6 months post-enrollment to evaluate changes in QOL from baseline to post-treatment, as measured by the Functional Assessment of Cancer Treatment- lymphoma (FACT-Lym). Secondary outcomes will assess patient self-efficacy in assessing for and managing treatment-related toxicities including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) and communicating these and other concerns across care settings. To support patients and facilitate the collection of key PROs, a digital health coaching solution provided by Pack Health will be provided to each participant over the 6-month study enrollment. The digital coaching program provides an evidence-based curriculum focused on monitoring and managing CAR T-cell associated toxicities, enhancing overall wellness post-treatment, and navigating within and between referring and treating facilities. The participating site(s) will collect longitudinal PRO data focused on QOL across physiologic and psychosocial domains that coaching personnel will access and review with participants.

A single cohort of up to 100 individuals receiving chimeric antigen receptor T cell therapy will be enrolled in the study, all of which will be enrolled in a 6-month digital health coaching program. Individuals will be enrolled at The Ohio State University Comprehensive Cancer Center.

Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel

Age, Race, Ethnicity, Sex at Birth, Gender Identity, Diagnosis, Treatment History, Co-morbid conditions, referring provider/institution, provider/institution for follow-up care, setting of CAR T-cell infusion

Complete response, partial response, stable disease, progressive disease, unknown/not evaluated

The SF-36 is a validated measure for the assessment of health-related quality of life for individuals with diverse chronic conditions, including individuals with hematologic malignancies. It consists of 36-items assessing 8 health domains, including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health. The instrument is scored on a scale of 0-100 for each of the 8 health domains. It was recently used in a study of quality-of-life following treatment with tisagenlecleucel.

As there are no currently validated instruments specific to CAR T-cell therapy, a 5-item assessment of patients' experience in monitoring, managing, and reporting treatment related toxicities will be created specifically for use in this study and will mirror the response scale in the CBI-B. This includes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident". The following items will be included: 1) Understand the treatment toxicities I may experience while receiving CAR T-cell therapy; 2) Identify the signs and symptoms of these toxicities; 3) Communicate symptoms to provider; 4) Manage symptoms according to provider's instructions; 5) Explain treatment to a healthcare provider

Novartis

Ohio State University Comprehensive Cancer Center

Central Nervous System Depressants

Other Dietary Supplements

Immunomodulating Agents

Benzocaine

Tannic Acid

ALETA-001 will be administered intravenously (IV) every two weeks.

ALETA-001

Emma Ingleson

Sridhar Chaganti, Dr

Ram Malladi, Dr

Cathy Burton, Dr

William Townsend, Dr

Jane Norman, Dr

Adam Gibb, Dr

Carlos Arias, Dr

This is a Phase I/II multicentre, open-label trial designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel chimeric antigen receptor (CAR) T-cell engager, ALETA-001, administered by intravenous (IV) infusion as a single agent every 2 weeks in patients with relapsed non-Hodgkin lymphoma (NHL) who have failed to optimally respond to prior treatment with anti-CD19 CAR T-cell therapy. This first in human study is divided into 2 parts: a safety lead-in phase (Phase I) and a dose expansion phase (Phase II). Different dose levels of ALETA-001 will be evaluated in Phase I in order to define a recommended dosing level and schedule for Phase II. Phase II will further evaluate the safety, PK and therapeutic activity of ALETA-001.

A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies

A Cancer Research Phase I/ II Trial of ALETA-001 in Participants Who Do Not Achieve or Maintain an Optimal Response to Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Malignancies

Individual de-identified patient data that underlie the results reported will be shared with researchers whose proposed use of the data is approved by a review committee of the Sponsor.

Determine a dose level that is deemed tolerable based on available safety and pharmacodynamic data.

DLTs will be assessed up to Day 28 and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the 28 days of the first dose of ALETA-001.

Related AEs are those considered by the investigator to be possibly, probably or highly probably related to ALETA-001. Events of cytokine release syndrome (CRS) and immune effector cell mediated neurotoxicity (ICANS) are graded according to the American Society for Transplantation and Cellular Therapy grading criteria. All other AEs are graded according to the Common Terminology Criteria for AEs (CTCAE) Version 5.0.

Best Overall Response according to Lugano criteria (Cheson, Journal of Clinical Oncology, 2014), the number of participants taking part in the Dose Expansion Phase with best overall response of complete response (CR), partial response (PR), no response or stable disease (SD/NR), and progressive disease (PD).

Median PFS measured from first dose of ALETA-001 to date of progression according to Lugano criteria or date of death without a previous progression recorded.

Median TTP measured from first dose of ALETA-001 to date of progression according to Lugano criteria. Participants who die without recorded progression will be censored.

Median OS measured from first dose of ALETA-001 to date of death due to any cause or to the date of censoring at the last time the participant was known to be alive.

Best Overall Response according to Lugano criteria, the number of participants taking part in the Safety Lead-in Phase with best overall response of complete response (CR), partial response (PR), no response or stable disease (SD), and progressive disease (PD).

Measurement of Cmax of ALETA-001 as appropriate.

Measurement of t1/2 of ALETA-001 as appropriate.

Measurement of AUC of ALETA-001 as appropriate.

Measurement of Vss of ALETA-001 as appropriate.

Measurement of CL of ALETA-001 as appropriate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy	NCT05064787	Lymphoma Lymphoma, B-Cel... Leukemia Multiple Myelom... Mantle Cell Lym... Follicular Lymp... Leukemia, Acute...	Digital Health ...	18 Years -	Pack Health
Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel	NCT05199961	Lymphoma, Large...	Digital Health ...	18 Years - 90 Years	Pack Health
Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy	NCT05064787	Lymphoma Lymphoma, B-Cel... Leukemia Multiple Myelom... Mantle Cell Lym... Follicular Lymp... Leukemia, Acute...	Digital Health ...	18 Years -	Pack Health
A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies	NCT06045910	Lymphoma, Non-H... Lymphoma, Large... Lymphoma, Mantl... Lymphoma, Folli... Lymphoma, B-Cel...	ALETA-001	16 Years -	Cancer Research UK
Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy	NCT05064787	Lymphoma Lymphoma, B-Cel... Leukemia Multiple Myelom... Mantle Cell Lym... Follicular Lymp... Leukemia, Acute...	Digital Health ...	18 Years -	Pack Health

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