A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation (E-CELERATE)

January 31, 2025 updated by: Angiocrine Bioscience

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
    • California
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
      • Sacramento, California, United States, 95817
        • UC Davis Comprehensive Cancer Center
      • San Diego, California, United States, 92093
        • UC San Diego Moores Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Sarah Cannon Research Institute, Colorado
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami - Sylvester Comprehensive Cancer Center
      • Tampa, Florida, United States, 33612-9416
        • University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University - Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois Cancer Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Simon Comprehensive Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center, Fairview
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Weill Cornell Medical College/New York Presbyterian Hospital
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Comprehensive Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute, Nashville
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 40 years old
  2. Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL)

  3. Candidates for HDT-AHCT with one of the following conditioning regimens:

    1. BEAM (carmustine, etoposide, cytarabine, melphalan)
    2. BeEAM (bendamustine, etoposide, cytarabine, melphalan)
  4. Achieved CR or PR prior to planned HDT
  5. ECOG ≤ 2
  6. Weight ≤ 1.6 × ideal body weight (IBW) per Devine formula
  7. Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia
  8. AST, ALT, and alkaline phosphatase < 3 × ULN
  9. Creatinine clearance ≥ 30 ml/min (calculated by Cockcroft Gault)
  10. LVEF ≥ 45% by MUGA or resting echocardiogram
  11. Pulmonary function (FEV1 and corrected DLCO) ≥ 45% predicted
  12. Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
  13. 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.
  14. 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
  15. Ability to provide written informed consent.

Exclusion Criteria:

  1. History of prior HCT
  2. Primary CNS lymphoma
  3. Lymphoma with CNS involvement at time of relapse prior to planned HDT-AHCT
  4. 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
  5. 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
  6. Subjects with a known history of HIV
  7. Subjects who have known hypersensitivity reactions to bovine (cow) proteins or documented allergy to DMSO
  8. Subject has other conditions that in the opinion of the investigator would require reduced dose (intensity) of BEAM or BeEAM regimens

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AB-205 plus standard-of-care preventive and supportive therapies.
Biological: AB-205
Allogeneic genetically engineered human umbilical vein endothelial cells
Other Names:
  • E-CEL cells
Placebo Comparator: Placebo plus standard-of-care preventive and supportive therapies.
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The absence of oral/GI severe regimen related toxicities (oral/GI SRRT).
Time Frame: 21 Days
21 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of oral/GI SRRT
Time Frame: 21 Days
21 Days
Symptom burden per MD Anderson Symptom Inventory (MDASI)
Time Frame: 21 Days
21 Days
Duration of febrile neutropenia
Time Frame: 21 Days
21 Days
Time to neutrophil engraftment
Time Frame: 21 Days
21 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angiocrine Bioscience

Collaborators

California Institute for Regenerative Medicine (CIRM)

Investigators

  • Study Director: Paul Finnegan, MD, Angiocrine Bioscience, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2022

Primary Completion (Actual)

December 29, 2023

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

December 16, 2021

First Submitted That Met QC Criteria

December 16, 2021

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-205-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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