Hodgkin LymphomaPhase 3E-CELERATENCT05181540
A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation
A Phase 3 study testing AB-205 in people with Hodgkin Lymphoma and Non Hodgkin Lymphoma, run by Angiocrine Bioscience at 28 sites in United States.
Trial summary
High-dose chemotherapy followed by blood stem cell transplantation is administered to lymphoma patients with an intention to cure. However, high-dose chemotherapy simultaneously causes damage to healthy tissues that frequently result in severe complications that lead to hospitalization and can be life threatening. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Non Hodgkin Lymphoma
- What is being tested?
- AB-205
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 28 sitesUnited States
- Study dates
- 21 Feb 2022to 31 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years old
- Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL)
- Candidates for HDT-AHCT with one of the following conditioning regimens:
- BEAM (carmustine, etoposide, cytarabine, melphalan)
- BeEAM (bendamustine, etoposide, cytarabine, melphalan)
- Achieved CR or PR prior to planned HDT
Show all 17Show fewer
- ECOG ≤ 2
- Weight ≤ 1.6 × ideal body weight (IBW) per Devine formula
- Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia
- AST, ALT, and alkaline phosphatase < 3 × ULN
- Creatinine clearance ≥ 30 ml/min (calculated by Cockcroft Gault)
- LVEF ≥ 45% by MUGA or resting echocardiogram
- Pulmonary function (FEV1 and corrected DLCO) ≥ 45% predicted
- Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
- Sexually active females of childbearing potential must have a negative urine pregnancy test and agree to use two accepted methods of contraception during the study and for 3 months after their last dose of study drug.
- Male subjects who are sexually active and who are partners of females of childbearing potential: agreement to use two forms of contraception as in criterion 12 above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug
- Ability to provide written informed consent.
Who cannot join
- History of prior HCT
- Primary CNS lymphoma
- Lymphoma with CNS involvement at time of relapse prior to planned HDT-AHCT
- Active malignancy other than the one for which the subject is undergoing HDT AHCT. Subjects with cervical carcinoma in situ or localized basal or squamous cell carcinoma treated with definitive surgery are eligible
- Subjects with a serious concomitant medical condition that could interfere with the conduct of the clinical trial, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring IV antibiotics
- Subjects with a known history of HIV
- Subjects who have known hypersensitivity reactions to bovine (cow) proteins or documented allergy to DMSO
- Subject has other conditions that in the opinion of the investigator would require reduced dose (intensity) of BEAM or BeEAM regimens
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322
University Of Maryland School Of Medicine
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Illinois Cancer Center
Chicago, Illinois, 60612
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Sarah Cannon Research Institute, Colorado
Denver, Colorado, 80218
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Hackensack University Medical Center
Hackensack, New Jersey, 07601
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
University of California, Los Angeles
Los Angeles, California, 90095
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
Sarah Cannon Research Institute, Nashville
Nashville, Tennessee, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Oregon Health and Science University
Portland, Oregon, 97239
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
UC San Diego Moores Cancer Center
San Diego, California, 92093
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9416
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase 3 Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of AB-205 Plus Standard of Care Versus Placebo Plus Standard of Care in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT) (E-CELERATE)
High-dose chemotherapy followed by blood stem cell transplantation is administered to lymphoma patients with an intention to cure. However, high-dose chemotherapy simultaneously causes damage to healthy tissues that frequently result in severe complications that lead to hospitalization and can be life threatening. These severe complications involve the blood, immune, gastro-intestinal systems, and other vital organs.
The purpose of this study is to determine if experimental therapy AB-205 (study drug) can prevent or reduce the occurrence and duration of the severe chemotherapy related complications when compared to placebo in patients with lymphoma undergoing treatment with high-dose chemotherapy and blood stem cell transplantation. All patients, whether treated with AB-205 or placebo, will receive standard preventive and supportive care therapies.
- Conditions
- Hodgkin Lymphoma, Non Hodgkin Lymphoma
- Being tested
- AB-205, Placebo
- Keywords
- Lymphoma, Cellular Therapy
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-205Biological
Also called E-CEL cells
Allogeneic genetically engineered human umbilical vein endothelial cells
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AB-205 plus standard-of-care preventive and supportive therapies. | Experimental | Not described Receives: Biological: AB-205 |
| Placebo plus standard-of-care preventive and supportive therapies. | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absence of oral/GI severe regimen related toxicities (oral/GI SRRT).
Measured: 21 Days
Secondary outcomes (4)
Duration of oral/GI SRRT
Measured: 21 Days
Symptom burden per MD Anderson Symptom Inventory (MDASI)
Measured: 21 Days
Duration of febrile neutropenia
Measured: 21 Days
Time to neutrophil engraftment
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start21 Feb 2022
- Primary completion29 Dec 2023
- Study completion31 Jan 2025
Why it stopped: Interim analysis showed lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiocrine Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Responsible party
- Sponsor
- Investigators
- Paul Finnegan, MD, Study director, Angiocrine Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181540
- Sponsor's protocol ID
- AB-205-301
- Acronym
- E-CELERATE
- Status last verified
- Jan 2025
- First submitted
- 16 Dec 2021
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of AB-205 Plus Standard of Care Versus Placebo Plus Standard of Care in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT) (E-CELERATE)
- ClinicalTrials.gov ID
- NCT05181540
- Acronym / sponsor ID
- E-CELERATE / AB-205-301
- Conditions
- Hodgkin Lymphoma, Non Hodgkin Lymphoma
- Keywords
- Lymphoma, Cellular Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed lack of efficacy
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Angiocrine BioscienceIndustry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High-dose chemotherapy followed by blood stem cell transplantation is administered to lymphoma patients with an intention to cure. However, high-dose chemotherapy simultaneously causes damage to healthy tissues that frequently result in severe complications that lead to hospitalization and can be life threatening. These severe complications involve the blood, immune, gastro-intestinal systems, and other vital organs.
The purpose of this study is to determine if experimental therapy AB-205 (study drug) can prevent or reduce the occurrence and duration of the severe chemotherapy related complications when compared to placebo in patients with lymphoma undergoing treatment with high-dose chemotherapy and blood stem cell transplantation. All patients, whether treated with AB-205 or placebo, will receive standard preventive and supportive care therapies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB-205 plus standard-of-care preventive and supportive therapies. | Experimental | Biological: AB-205 |
| Placebo plus standard-of-care preventive and supportive therapies. | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 40 years old
- Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL)
- Candidates for HDT-AHCT with one of the following conditioning regimens:
- Achieved CR or PR prior to planned HDT
- ECOG ≤ 2
Key exclusion criteria (8 listed)
- History of prior HCT
- Primary CNS lymphoma
- Lymphoma with CNS involvement at time of relapse prior to planned HDT-AHCT
- Active malignancy other than the one for which the subject is undergoing HDT AHCT. Subjects with cervical carcinoma in situ or localized basal or squamous cell carcinoma treated with definitive surgery are eligible
- Subjects with a serious concomitant medical condition that could interfere with the conduct of the clinical trial, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring IV antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB-205Also: E-CEL cellsAllogeneic genetically engineered human umbilical vein endothelial cells | Biological | AB-205 plus standard-of-care preventive and supportive therapies. |
| PlaceboPlacebo | Other | Placebo plus standard-of-care preventive and supportive therapies. |
Primary outcome
The absence of oral/GI severe regimen related toxicities (oral/GI SRRT).
Time frame: 21 Days
4 secondary outcomes
Duration of oral/GI SRRT
Time frame: 21 Days
Symptom burden per MD Anderson Symptom Inventory (MDASI)
Time frame: 21 Days
Duration of febrile neutropenia
Time frame: 21 Days
Time to neutrophil engraftment
Time frame: 21 Days
Results and safety
The study was stopped early (reason given: Interim analysis showed lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Finnegan, MD study director
Angiocrine Bioscience, Inc.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AB-205 in people with Hodgkin Lymphoma and Non Hodgkin Lymphoma, run by Angiocrine Bioscience at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim analysis showed lack of efficacy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absence of oral/GI severe regimen related toxicities (oral/GI SRRT). (time frame: 21 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.