NCT06500273 · Allogene Therapeutics
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
(ALPHA3)
What this study is about
This is a randomly assigned, where both patients and doctors know the treatment given study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a full disappearance of disease signs or significant shrinkage of disease signs suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ experimental Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the effectiveness and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic
View original scientific 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™.
Interventions
GENETIC
cemacabtagene ansegedleucel
An allogeneic CAR T cell therapy targeting CD19
DRUG
Fludarabine
Chemotherapy for lymphodepletion
DRUG
Cyclophosphamide
Chemotherapy for lymphodepletion
DEVICE
Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™
A diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for LBCL.
Primary outcome measures
Event-free survival per independent review committee assessment
Time frame: Up to 60 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- LBCL with history of central nervous system involvement, transformed from other mali
Where
- Gilbert, Arizona
- Hot Springs, Arkansas
- Berkeley, California
- Duarte, California
- Los Angeles, California
- Sacramento, California
- San Diego, California
- San Francisco, California
- Denver, Colorado
- Newark, Delaware
- Washington D.C., District of Columbia
- Miami, Florida
And 40 more locations — see the full list below.
Collaborators
Foresight Diagnostics, Inc., Natera, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations