NCT04026737

Brief Summary

This is an observational study aiming to prospectively define the rate of occurrence, natural history and progression of cardiac dysfunction in adults, and to identify the patients at high risk of developing cardiovascular events. The study enrolls patients prior to infusion with CART cell therapy and follows them with serial echocardiography, cardiac biomarkers, clinical data, and quality of life questionnaire.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2022

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

3.3 years

First QC Date

July 17, 2019

Last Update Submit

February 5, 2026

Conditions

LeukemiaLymphomaCardiotoxicityRisk Factor, CardiovascularImmunotherapy

Keywords

Cardiotoxicity of Cancer TherapyCardio-OncologyCART Cell Therapy

Outcome Measures

Primary Outcomes (1)

  • Incidence of Left Ventricular (LV) Dysfunction

    LV dysfunction, defined as a decrease in LV ejection fraction of at least 10% to less than or equal to 53%

    6 months

Secondary Outcomes (1)

  • Incidence of Cardiovascular Events

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients diagnosed with CD19+ malignancy (including but not limited to acute lymphoblastic leukemia, chronic lymphocytic leukemia, and difuse large B cell lymphoma) and scheduled for treatment with CART cells will be enrolled prior to infusion of CART cells.

You may qualify if:

  • At least 18 years of age
  • Diagnosed with CD19+ malignancy undergoing treatment with CART cells

You may not qualify if:

  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, and buffy are banked

MeSH Terms

Conditions

LeukemiaLymphomaCardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Study Officials

  • Marielle Scherrer-Crosbie, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 19, 2019

Study Start

July 22, 2019

Primary Completion

November 16, 2022

Study Completion

November 16, 2022

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

US(1)