A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation
NCT ID: NCT05181540
Last Updated: 2025-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
130 participants
INTERVENTIONAL
2022-02-21
2025-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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AB-205 plus standard-of-care preventive and supportive therapies.
AB-205
Allogeneic genetically engineered human umbilical vein endothelial cells
Placebo plus standard-of-care preventive and supportive therapies.
Placebo
Placebo
Interventions
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AB-205
Allogeneic genetically engineered human umbilical vein endothelial cells
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
40 Years
ALL
No
Sponsors
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California Institute for Regenerative Medicine (CIRM)
OTHER
Angiocrine Bioscience
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Finnegan, MD
Role: STUDY_DIRECTOR
Angiocrine Bioscience, Inc.
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
University of California, Los Angeles
Los Angeles, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
UC San Diego Moores Cancer Center
San Diego, California, United States
Sarah Cannon Research Institute, Colorado
Denver, Colorado, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University Of Maryland School Of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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Other Identifiers
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AB-205-301
Identifier Type: -
Identifier Source: org_study_id
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