Study Stopped
Interim analysis showed lack of efficacy
A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation
E-CELERATE
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)
1 other identifier
interventional
130
1 country
28
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2022
Typical duration for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2021
CompletedFirst Posted
Study publicly available on registry
January 6, 2022
CompletedStudy Start
First participant enrolled
February 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedFebruary 4, 2025
January 1, 2025
1.9 years
December 16, 2021
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The absence of oral/GI severe regimen related toxicities (oral/GI SRRT).
21 Days
Secondary Outcomes (4)
Duration of oral/GI SRRT
21 Days
Symptom burden per MD Anderson Symptom Inventory (MDASI)
21 Days
Duration of febrile neutropenia
21 Days
Time to neutrophil engraftment
21 Days
Study Arms (2)
AB-205 plus standard-of-care preventive and supportive therapies.
EXPERIMENTALPlacebo plus standard-of-care preventive and supportive therapies.
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
- 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.
- +2 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
UC San Diego Moores Cancer Center
San Diego, California, 92093, United States
Sarah Cannon Research Institute, Colorado
Denver, Colorado, 80218, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9416, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322, United States
University of Illinois Cancer Center
Chicago, Illinois, 60612, United States
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
University Of Maryland School Of Medicine
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, 10065, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Sarah Cannon Research Institute, Nashville
Nashville, Tennessee, 37203, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul Finnegan, MD
Angiocrine Bioscience, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2021
First Posted
January 6, 2022
Study Start
February 21, 2022
Primary Completion
December 29, 2023
Study Completion
January 31, 2025
Last Updated
February 4, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share