RECRUITING

Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation. In this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide. Prior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen.

Official Title

A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma

Quick Facts

Study Start:2024-06-18
Study Completion:2031-08-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06500273

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report.
  2. 2. Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy.
  3. 3. Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation
  4. 4. Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
  5. 5. Adult participants ≥18 years of age.
  6. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  7. 7. Adequate hematological, renal, hepatic, pulmonary, and cardiac function
  8. 8. Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.
  1. 1. LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell/histiocyte rich LBCL.
  2. 2. Prior treatment with anti-CD19 targeted therapies.
  3. 3. Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed.
  4. 4. Active and clinically significant autoimmune disease.
  5. 5. Active systemic bacterial, fungal, or viral infections requiring systemic treatment.
  6. 6. History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.

Contacts and Locations

Study Contact

Allogene Therapeutics, Inc
CONTACT
+1 415-604-5696
clinicaltrials@allogene.com

Principal Investigator

Allogene Study Director
STUDY_DIRECTOR
Allogene Therapeutics, Inc.

Study Locations (Sites)

Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
Alta Bates Summit Medical Center
Berkeley, California, 94704
United States
City of Hope
Duarte, California, 91010
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of California, Los Angeles
Los Angeles, California, 90095
United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 91817
United States
University of California, San Diego
San Diego, California, 92037
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
United States
Medical Oncology Hematology Consultants
Newark, Delaware, 19713
United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
United States
Advent Health Cancer Institute
Orlando, Florida, 32804
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Augusta University Georgia Cancer Center
Augusta, Georgia, 30912
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46237
United States
The University of Kansas Hospital
Kansas City, Kansas, 66205
United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536
United States
University of Louisville Health Brown Cancer Center
Louisville, Kentucky, 40202
United States
Norton Cancer Institute
Louisville, Kentucky, 40207
United States
The Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Missouri - Ellis Fischel Cancer Center
Columbia, Missouri, 65212
United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
United States
Astera Cancer Care
East Brunswick, New Jersey, 08816
United States
John Theurer Cancer Center
Hackensack, New Jersey, 07601
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Columbia University Irving Medical Center and New York-Presbyterian Hospital
New York, New York, 10032
United States
Novant Health Cancer Institute- Hematology
Charlotte, North Carolina, 28204
United States
Duke Blood Cancer Center
Durham, North Carolina, 27705
United States
Oncology Hematology Care - Kenwood
Cincinnati, Ohio, 45236
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Oncology Associates of Oregon
Eugene, Oregon, 97401
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Texas Oncology - Central South
Austin, Texas, 78705
United States
Texas Oncology - Dallas Fort Worth
Dallas, Texas, 75246
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Texas Transplant Institute
San Antonio, Texas, 78229
United States
Texas Oncology - Tyler
Tyler, Texas, 75702
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
United States
Intermountain Health LDS Hospital
Salt Lake City, Utah, 84142
United States
University of Virginia
Charlottesville, Virginia, 22903
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Allogene Therapeutics

  • Allogene Study Director, STUDY_DIRECTOR, Allogene Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-18
Study Completion Date2031-08-24

Study Record Updates

Study Start Date2024-06-18
Study Completion Date2031-08-24

Terms related to this study

Keywords Provided by Researchers

  • Diffuse large B-cell lymphoma
  • DLBCL
  • Primary mediastinal B-cell lymphoma
  • LBCL
  • High grade B-cell lymphoma
  • HGBCL
  • Double-hit lymphoma
  • High-risk lymphoma
  • Minimal Residual Disease
  • MRD
  • CAR T
  • Allogeneic CAR T
  • CD19
  • cema-cel
  • cemacabtagene ansegedleucel
  • PMBCL
  • Consolidation
  • First-line
  • Front-line
  • Frontline
  • PhasED-Seq™
  • CLARITY™
  • AlloCAR T™

Additional Relevant MeSH Terms

  • Large B-cell Lymphoma