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Terminated early for business reasons.
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The purpose of the EXPAND study is to assess the safety and clinical efficacy of ALLO-647 combined with fludarabine and cyclophosphamide compared to fludarabine and cyclophosphamide alone in a lymphodepletion regimen prior to ALLO-501A CAR T therapy in adults with relapsed or refractory large B-cell lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide | Experimental | ALLO-501A CAR T cells infused following lymphodepletion |
|
| Lymphodepletion with fludarabine and cyclophosphamide | Experimental | ALLO-501A CAR T cells infused following lymphodepletion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLO-647 | Biological | ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) of a Lymphodepletion Regimen Containing FCA vs FC Alone Per Independent Review Committee | To assess the clinical efficacy of ALLO-647 (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by PFS and assessed by Independent Review Committee (IRC) in subjects with R/R (Relapsed / Refractory) LBCL (Large B Cell Lymphoma). In this study, PFS is defined as the time from randomization to disease progression, or relapse per the Lugano classification criteria (Cheson et al, 2014) as assessed by IRC or death. | Up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall-response Rate (ORR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee | To assess the clinical efficacy of ALLO-647 as measured by ORR and assessed by Independent Review Committee (IRC) between treatment arms. ORR is defined as best overall response (Complete Response and Partial Response, assessed using the Lugano classification criteria 2014; Cheson , et al, 2014) by IRC at any time up through commencement of new anti-cancer therapy or withdrawal of consent. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States | ||
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The study enrolled participants from the United States and Europe. The informed consent date of the first participant was 01 November 2023, and the informed consent date of the last participant was 04 December 2023. The study was terminated prior to completion for business reasons, not due to safety or efficacy concerns.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA) | Lymphodepletion with FCA followed by treatment with ALLO-501A arm. Lymphodepletion:
Treatment with ALLO-501A: • ALLO-501A as a single IV dose of 120 × 10^6 CAR+ T cells on Day 0 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol with Statistical Analysis Plan Original |
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| Fludarabine | Drug | Chemotherapy for lymphodepletion |
|
| Cyclophosphamide | Drug | Chemotherapy for lymphodepletion |
|
| ALLO-501A | Genetic | ALLO-501A is an allogeneic CAR T cell therapy targeting CD19 |
|
| Up to 60 months |
| Event-Free-Survival (EFS) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee | To assess clinical efficacy of ALLO-647 with FC (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by Event-Free Survival (EFS) and assessed by Independent Review Committee (IRC) in subjects with R/R LBCL. EFS is defined as the time from randomization to disease progression or relapse per the Lugano classification criteria 2014 as assessed by IRC, new anti-cancer therapy, or death. | Up to 60 months |
| Duration of Response (DOR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee | To characterize the efficacy of ALLO-647 as measured by Duration of Response (DOR) and assessed by Independent Review Committee (IRC) between treatment arms. DOR is defined as time from the first observed response to disease progression or relapse (per IRC) or death. | Up to 60 months |
| Overall Survival (OS) of a Lymphodepletion Regimen Containing FCA vs FC | To characterize the efficacy of ALLO-647 as measured by OS, defined as the time from randomization to death. | Up to 60 months, study completion, or death, whichever occurs earlier. Specifically, OS was followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively. |
| Duration of Response, Event-Free Survival and Progression-Free Survival of a Lymphodepletion Regimen Containing FCA vs FC Based on Response Assessment Per Investigator Review | To characterize the efficacy of ALLO-647 as measured by response rate per investigator, Duration of Response (DOR), Event-Free Survival (EFS), Progression-Free Survival (PFS), assessed by investigator assessments between treatment arms. DOR is defined as time from the first observed response to disease progression or relapse per investigator assessment, or death. EFS is defined as the time from randomization to disease progression or relapse per investigator assessment per the Lugano classification criteria, new anti-cancer therapy, or death. PFS is defined as time from the randomization to progression or relapse per investigator assessment per the Lugano classification criteria, or death. | Neither participant was a responder, therefore DOR was not followed. EFS and PFS were followed from first dose of study treatment until disease progression, subsequent anticancer therapy, or death. EFS and PFS were followed for 0.99 to 1.84 months. |
| Overall Response Rate of a Lymphodepletion Regimen Containing FCA vs FC Based on Response Assessment Per Investigator Review | To characterize the efficacy of ALLO-647 as measured by response rate per investigator, Overall Response Rate (ORR), and assessed by investigator assessments between treatment arms. ORR in FCA vs FC alone per investigator assessment at any time up through commencement of new anti-cancer therapy or withdrawal of consent. | Overall Response Rate was followed until disease progression or subsequent anticancer therapy, whichever occurred earlier. Specifically, ORR was followed for 0.99 to 1.84 months for each participant in the FCA and FC arm, respectively. |
| Depth and Duration of a Lymphodepletion Regimen Containing FCA vs FC | To characterize the depth and duration of lymphodepletion with and without ALLO-647, as assessed by lymphocyte count. | From study treatment to study discontinuation, death, withdrawal of consent, or date of initiation of another anticancer therapy, whichever occurs first, for a maximum of 9 months. Only Day 28 lymphocyte counts are available for both participants. |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | To evaluate the overall safety profile of ALLO-647 by comparing FCA lymphodepletion with FC lymphodepletion. | Up to 60 months, study completion, or death, whichever occurs earlier. TEAEs were followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively. |
| Incidence of ALLO-501A Related Treatment Emergent Adverse Events | To evaluate the overall safety profile of ALLO-501A following lymphodepletion. | Up to 60 months, study completion, or death, whichever occurs earlier. Related TEAEs were followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively. |
| Universitair Ziekenhuis Brussel |
| Brussels |
| 1090 |
| Belgium |
| FG001 | Lymphodepletion With Fludarabine, and Cyclophosphamide (FC) | Lymphodepletion with FC followed by treatment with ALLO-501A arm. Lymphodepletion:
Treatment with ALLO-501A: • ALLO-501A as a single IV dose of 120 × 10^6 CAR+ T cells on Day 0 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA) | Lymphodepletion with FCA followed by treatment with ALLO-501A arm. Lymphodepletion:
Treatment with ALLO-501A: • ALLO-501A as a single IV dose of 120 × 10^6 CAR+ T cells on Day 0 |
| BG001 | Lymphodepletion With Fludarabine, and Cyclophosphamide (FC) | Lymphodepletion with FC followed by treatment with ALLO-501A arm. Lymphodepletion:
Treatment with ALLO-501A: • ALLO-501A as a single IV dose of 120 × 10^6 CAR+ T cells on Day 0 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) of a Lymphodepletion Regimen Containing FCA vs FC Alone Per Independent Review Committee | To assess the clinical efficacy of ALLO-647 (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by PFS and assessed by Independent Review Committee (IRC) in subjects with R/R (Relapsed / Refractory) LBCL (Large B Cell Lymphoma). In this study, PFS is defined as the time from randomization to disease progression, or relapse per the Lugano classification criteria (Cheson et al, 2014) as assessed by IRC or death. | Intent-to-Treat (ITT) Analysis Set: All randomized participants. Data does not exist as assessment of efficacy per Independent Review Committee was not performed. | Posted | Median | 95% Confidence Interval | Participants | Up to 60 months |
|
| |||||||||||||||||||
| Secondary | Overall-response Rate (ORR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee | To assess the clinical efficacy of ALLO-647 as measured by ORR and assessed by Independent Review Committee (IRC) between treatment arms. ORR is defined as best overall response (Complete Response and Partial Response, assessed using the Lugano classification criteria 2014; Cheson , et al, 2014) by IRC at any time up through commencement of new anti-cancer therapy or withdrawal of consent. | ITT Analysis Set: All randomized participants. Data does not exist as assessment of efficacy per Independent Review Committee was not performed. | Posted | Count of Participants | Participants | Up to 60 months |
| |||||||||||||||||||||
| Secondary | Event-Free-Survival (EFS) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee | To assess clinical efficacy of ALLO-647 with FC (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by Event-Free Survival (EFS) and assessed by Independent Review Committee (IRC) in subjects with R/R LBCL. EFS is defined as the time from randomization to disease progression or relapse per the Lugano classification criteria 2014 as assessed by IRC, new anti-cancer therapy, or death. | ITT Analysis Set: All randomized participants. Data does not exist as assessment of efficacy per Independent Review Committee was not performed. | Posted | Median | 95% Confidence Interval | Participants | Up to 60 months |
| ||||||||||||||||||||
| Secondary | Duration of Response (DOR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee | To characterize the efficacy of ALLO-647 as measured by Duration of Response (DOR) and assessed by Independent Review Committee (IRC) between treatment arms. DOR is defined as time from the first observed response to disease progression or relapse (per IRC) or death. | ITT Analysis Set: All randomized participants. Data does not exist as assessment of efficacy per Independent Review Committee was not performed. | Posted | Median | 95% Confidence Interval | Participants | Up to 60 months |
| ||||||||||||||||||||
| Secondary | Overall Survival (OS) of a Lymphodepletion Regimen Containing FCA vs FC | To characterize the efficacy of ALLO-647 as measured by OS, defined as the time from randomization to death. | ITT Analysis Set: All randomized participants. | Posted | Median | Full Range | Months | Up to 60 months, study completion, or death, whichever occurs earlier. Specifically, OS was followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively. |
| ||||||||||||||||||||
| Secondary | Duration of Response, Event-Free Survival and Progression-Free Survival of a Lymphodepletion Regimen Containing FCA vs FC Based on Response Assessment Per Investigator Review | To characterize the efficacy of ALLO-647 as measured by response rate per investigator, Duration of Response (DOR), Event-Free Survival (EFS), Progression-Free Survival (PFS), assessed by investigator assessments between treatment arms. DOR is defined as time from the first observed response to disease progression or relapse per investigator assessment, or death. EFS is defined as the time from randomization to disease progression or relapse per investigator assessment per the Lugano classification criteria, new anti-cancer therapy, or death. PFS is defined as time from the randomization to progression or relapse per investigator assessment per the Lugano classification criteria, or death. | ITT Analysis Set: All randomized participants. Duration of Response data is not applicable since there are no responders per investigator assessment. | Posted | Median | Full Range | Months | Neither participant was a responder, therefore DOR was not followed. EFS and PFS were followed from first dose of study treatment until disease progression, subsequent anticancer therapy, or death. EFS and PFS were followed for 0.99 to 1.84 months. |
| ||||||||||||||||||||
| Secondary | Overall Response Rate of a Lymphodepletion Regimen Containing FCA vs FC Based on Response Assessment Per Investigator Review | To characterize the efficacy of ALLO-647 as measured by response rate per investigator, Overall Response Rate (ORR), and assessed by investigator assessments between treatment arms. ORR in FCA vs FC alone per investigator assessment at any time up through commencement of new anti-cancer therapy or withdrawal of consent. | ITT Analysis Set: All randomized participants. | Posted | Count of Participants | Participants | Overall Response Rate was followed until disease progression or subsequent anticancer therapy, whichever occurred earlier. Specifically, ORR was followed for 0.99 to 1.84 months for each participant in the FCA and FC arm, respectively. |
| |||||||||||||||||||||
| Secondary | Depth and Duration of a Lymphodepletion Regimen Containing FCA vs FC | To characterize the depth and duration of lymphodepletion with and without ALLO-647, as assessed by lymphocyte count. | Safety-Analysis Set: All randomized participants who received at least one (partial or complete) dose of FCA/FC or ALLO-501A. Only Day 28 lymphocyte counts are available for both participants. | Posted | Mean | Full Range | cells/cubic millimeter | From study treatment to study discontinuation, death, withdrawal of consent, or date of initiation of another anticancer therapy, whichever occurs first, for a maximum of 9 months. Only Day 28 lymphocyte counts are available for both participants. |
| ||||||||||||||||||||
| Secondary | Incidence of Treatment-Emergent Adverse Events (TEAEs) | To evaluate the overall safety profile of ALLO-647 by comparing FCA lymphodepletion with FC lymphodepletion. | Safety-Analysis Set: All randomized participants who received at least one (partial or complete) dose of ALLO-647 or ALLO-501A. | Posted | Count of Participants | Participants | Up to 60 months, study completion, or death, whichever occurs earlier. TEAEs were followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively. |
| |||||||||||||||||||||
| Secondary | Incidence of ALLO-501A Related Treatment Emergent Adverse Events | To evaluate the overall safety profile of ALLO-501A following lymphodepletion. | Safety-Analysis Set: All randomized participants who received at least one (partial or complete) dose of ALLO-647 or ALLO-501A. | Posted | Count of Participants | Participants | Up to 60 months, study completion, or death, whichever occurs earlier. Related TEAEs were followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively. |
|
From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA) | Lymphodepletion with FCA followed by treatment with ALLO-501A arm. Lymphodepletion:
Treatment with ALLO-501A: • ALLO-501A as a single IV dose of 120 × 10^6 CAR+ T cells on Day 0 | 1 | 1 | 0 | 1 | 1 | 1 |
| EG001 | Lymphodepletion With Fludarabine, and Cyclophosphamide (FC) | Lymphodepletion with FC followed by treatment with ALLO-501A arm. Lymphodepletion:
Treatment with ALLO-501A: • ALLO-501A as a single IV dose of 120 × 10^6 CAR+ T cells on Day 0 | 1 | 1 | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus Tachycardia | Cardiac disorders | MedDRA (version 26) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (version 26) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (version 26) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (version 26) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (version 26) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (version 26) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (version 26) | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | MedDRA (version 26) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (version 26) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (version 26) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (version 26) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (version 26) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (version 26) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (version 26) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (version 26) | Systematic Assessment |
| |
| Urinary tract disorder | Renal and urinary disorders | MedDRA (version 26) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (version 26) | Systematic Assessment |
|
ALLO-647-201 (EXPAND) was a Phase 2 study that was terminated prior to completion for reasons not related to safety or efficacy concerns. No analyses of the baseline, disposition, safety, primary, secondary, nor exploratory endpoints were performed due to the limited enrollment and data collected during the study. Data were listed but not summarized.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Allogene Therapeutics, Inc | (+1) 415-604-5696 | clinicaltrials@allogene.com |
| Jun 24, 2022 |
| Oct 22, 2025 |
| Prot_SAP_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol with Statistical Analysis Plan Amendment 1 | Oct 13, 2022 | Oct 22, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Belgium |
|
|
|
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| Units | Counts |
|---|
| Participants |
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| OG001 | Lymphodepletion With Fludarabine, and Cyclophosphamide (FC) | Lymphodepletion with FC followed by treatment with ALLO-501A arm. Lymphodepletion:
Treatment with ALLO-501A: • ALLO-501A as a single IV dose of 120 × 10^6 CAR+ T cells on Day 0 |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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