NCT05181540TerminatedPhase 3
A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation
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)
Source: ClinicalTrials.gov · Last updated 4 Feb 2025
Reason given: Interim analysis showed lack of efficacy
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 130 (actual)
- First submitted
- 16 Dec 2021
- Start date
- 21 Feb 2022
- Primary completion date
- 29 Dec 2023
- Lead sponsor
- Angiocrine Bioscience
- Diseases
- Hodgkin lymphoma
- NCT number
- NCT05181540
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior HCT
- 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
Other illness
- 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
Other
- Primary CNS lymphoma
Who the study is looking for
- 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.
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan | Ann Arbor | United States | Unknown status |
| Emory University/Winship Cancer Institute | Atlanta | United States | Unknown status |
| University of Maryland School of Medicine | Baltimore | United States | Unknown status |
| Massachusetts General Hospital | Boston | United States | Unknown status |
| Beth Israel Deaconess Medical Center | Boston | United States | Unknown status |
| University of Illinois Cancer Center | Chicago | United States | Unknown status |
| The Ohio State University Comprehensive Cancer Center | Columbus | United States | Unknown status |
| Sarah Cannon Research Institute, Colorado | Denver | United States | Unknown status |
| City of Hope Comprehensive Cancer Center | Duarte | United States | Unknown status |
| Banner MD Anderson Cancer Center | Gilbert | United States | Unknown status |
| Hackensack University Medical Center | Hackensack | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center | Houston | United States | Unknown status |
| Indiana University Simon Comprehensive Cancer Center | Indianapolis | United States | Unknown status |
| University of Iowa Hospitals & Clinics | Iowa City | United States | Unknown status |
| University of California, Los Angeles | Los Angeles | United States | Unknown status |
| University of Miami - Sylvester Comprehensive Cancer Center | Miami | United States | Unknown status |
| University of Minnesota Medical Center, Fairview | Minneapolis | United States | Unknown status |
| Sarah Cannon Research Institute - Nashville | Nashville | United States | Unknown status |
| Vanderbilt-Ingram Cancer Center | Nashville | United States | Unknown status |
| Weill Cornell Medical College-New York Presbyterian Hospital | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center | New York | United States | Unknown status |
| Fox Chase Cancer Center | Philadelphia | United States | Unknown status |
| Oregon Health and Science University | Portland | United States | Unknown status |
| UC Davis Comprehensive Cancer Center | Sacramento | United States | Unknown status |
| UC San Diego Moores Cancer Center | San Diego | United States | Unknown status |
| Fred Hutchinson Cancer Center | Seattle | United States | Unknown status |
| University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute | Tampa | United States | Unknown status |
| MedStar Georgetown University Hospital | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.