Multiparametric Cardiac MRI in Patients Under CAR T-cell Therapy

NCT05414162 | Unknown DMC

• 1 other identifier: 81/22
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Recently chimeric antigen receptor (CAR) T-cell therapy, a new class of chemo therapy, has gained regulatory approval for the treatment of diseases such as B-cell lymphoma. Known side effects include cytokine release syndrome, which has been described to lead to myocarditis, but larger studies exploring this relationship are currently lacking. In this prospective study, the investigators aim to explore the potential effects of CAR T-cell therapy using cardiac MRI on the heart.

Conditions

DLBCL; Multiple Myeloma; Cytokine Release Syndrome; Myocarditis; CAR T-cell Therapy; ALL; PCBCL; Follicular Lymphoma; MCL

Keywords

Cardiac; MRI; CAR T-cell therapy; Myocarditis; CRS

Outcome Measures

Primary Outcomes (3)

• Extent and pattern of acute cardiac effects of CAR T-cell therapy

  To investigate to what extent and with which patterns CAR T cell therapy leads to acute cardiac effects in terms of inflammation, fibrosis, and myocardial dysfunction that can be detected with cardiac MRI.

  2 weeks

• Long-term cardiac remodeling effects of CAR T-cell therapy

  To explore whether CAR T cell therapy leads to long-term cardiac remodeling effects in terms of inflammation, fibrosis, and myocardial dysfunction that can be detected with cardiac MRI.

  6 months

• Correlate MRI findings with clinical course

  To assess whether changes in cardiac MRI parameters obtained from objectives 1 and 2 correlate with the clinical course (e.g., CRS development), cytokines and immunological markers and might predict major adverse cardiac events (MACE).

  6 months

Study Arms (1)

CAR T-cell Therapy Group

Hematooncological patients undergoing CAR T-cell therapy with Tisagenlecleucel, Axicabtagen-ciloleucel, Idecabtagen-vicleucel, Brexucabtagene autoleucel, Lisocabtagene maraleucel or Ciltacabtagene Autoleucel (dosages, frequency and duration to be determined by the treating oncologist).

Diagnostic Test: Cardiac MRI

Interventions

Cardiac MRI DIAGNOSTIC_TEST

Hematooncology patients under CAR T-cell therapy will receive 3 MRI examinations: at baseline, within 2 weeks of start of CAR T-cell therapy, and at 6 months follow-up.

CAR T-cell Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a histopathologically confirmed B-cell lymphoma or multiple myeloma who are planned for CAR T-cell therapy who fulfill the inclusion and exlcusion criteria will be recruited.

You may qualify if:

• Patients undergoing CAR T-cell therapy
• Consent to participate in study

You may not qualify if:

• Inability to undergo MRI examinations due to large metallic implants, cardiac pacemakers/neurostimulators, or claustrophobia
• Known cardiac conditions such as status post heart attack or myocarditis, complex congenital heard disease, or cardiomyopathies.
• Birth control using an IUD.
• Pregnancy or breastfeeding.
• Renal insufficiency with a GFR below 30 ml/min/1.73m2

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Multiple Myeloma; Cytokine Release Syndrome; Myocarditis; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Cardiomyopathies; Heart Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Lymphatic Diseases

Study Officials

• Julian Luetkens, MD

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

• Annkristin Heine, MD

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

• Tobias Holderried, MD

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

• Dmitrij Kravchenko, MD

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Luetkens, MD

CONTACT

+49 228 287 11831; julian.luetkens@ukbonn.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiovascular Imaging, Principal Investigator, Senior Physician

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 10, 2022
• Study Start: May 16, 2022
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2025
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

DE (1)