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NCT06500273 | RECRUITING | Large B-cell Lymphoma

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

Allogene Therapeutics

Brief Summary:

This is a randomized, open-label study in adult patients who have completed standard first line of 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. The study is conducted in 2 consecutive parts that will be enrolled continuously. In Part A of the study, participants with MRD are randomized to one of two treatment arms or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide administered with or without the anti-CD52 monoclonal antibody, ALLO-647. Part A will culminate with the selection of the lymphodepletion regimen to advance to Part B. Part B will evaluate the selected lymphodepletion regimen followed by cema-cel as compared with observation.

Condition or disease

Large B-cell Lymphoma

Intervention/treatment

cemacabtagene ansegedleucel

ALLO-647

Fludarabine

Cyclophosphamide

Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 250 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-06-18
Estimated Primary Completion Date : 2027-08-24
Estimated Study Completion Date : 2031-08-24

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • 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. 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. Participant achieved CR, or PR suitable for observation at the end of first line therapy based on PET/CT evaluation
  • 4. Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
  • 5. Adult participants ≥18 years of age.
  • 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • 7. Adequate hematological, renal, hepatic, pulmonary, and cardiac function
  • 8. Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.
  • Key Exclusion Criteria
    • 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. Prior treatment with anti-CD19 targeted therapies.
    • 3. Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed.
    • 4. Active and clinically significant autoimmune disease.
    • 5. Active systemic bacterial, fungal, or viral infections requiring systemic treatment (e.g., HIV).
    • 6. History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

Location Details

NCT06500273

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Alta Bates Summit Medical Center

Berkeley, California, United States, 94704

RECRUITING

United States, California

City of Hope

Duarte, California, United States, 91010

RECRUITING

United States, California

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

RECRUITING

United States, California

University of California, Davis Comprehensive Cancer Center

Sacramento, California, United States, 91817

RECRUITING

United States, Colorado

Rocky Mountain Cancer Centers

Denver, Colorado, United States, 80218

RECRUITING

United States, Delaware

Medical Oncology Hematology Consultants

Newark, Delaware, United States, 19713

RECRUITING

United States, Florida

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States, 33176

RECRUITING

United States, Florida

Advent Health Cancer Institute

Orlando, Florida, United States, 32804

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612

RECRUITING

United States, Indiana

Indiana Blood and Marrow Transplantation

Indianapolis, Indiana, United States, 46237

RECRUITING

United States, Kansas

The University of Kansas Hospital

Kansas City, Kansas, United States, 66205

RECRUITING

United States, Kentucky

University of Kentucky Medical Center

Lexington, Kentucky, United States, 40536

RECRUITING

United States, Kentucky

University of Louisville Health Brown Cancer Center

Louisville, Kentucky, United States, 40202

RECRUITING

United States, Kentucky

Norton Cancer Institute

Louisville, Kentucky, United States, 40207

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Missouri

Washington University School of Medicine - Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, New Jersey

Astera Cancer Care

East Brunswick, New Jersey, United States, 08816

RECRUITING

United States, New Jersey

John theurore Cancer Center

Hackensack, New Jersey, United States, 07601

RECRUITING

United States, New Jersey

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08901

RECRUITING

United States, New York

Columbia University Irving Medical Center and New York-Presbyterian Hospital

New York, New York, United States, 10032

RECRUITING

United States, Ohio

Oncology Hematology Care - Kenwood

Cincinnati, Ohio, United States, 45236

RECRUITING

United States, Ohio

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45267

RECRUITING

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Oregon

Oncology Associates of Oregon

Eugene, Oregon, United States, 97401

RECRUITING

United States, Texas

Texas Oncology - Central South

Austin, Texas, United States, 78705

RECRUITING

United States, Texas

Texas Oncology - Dallas Fort Worth

Dallas, Texas, United States, 75246

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

Texas Transplant Institute

San Antonio, Texas, United States, 78229

RECRUITING

United States, Texas

Texas Oncology - Tyler

Tyler, Texas, United States, 75702

RECRUITING

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22903

RECRUITING

United States, Virginia

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031

RECRUITING

United States, Virginia

Virginia Oncology Associates - Norfolk

Norfolk, Virginia, United States, 23502

RECRUITING

United States, Washington

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109