A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation
- Conditions
- Non Hodgkin LymphomaHodgkin Lymphoma
- Interventions
- Other: Placebo
- Registration Number
- NCT05181540
- Lead Sponsor
- Angiocrine Bioscience
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 130
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AB-205 plus standard-of-care preventive and supportive therapies. AB-205 - Placebo plus standard-of-care preventive and supportive therapies. Placebo -
- Primary Outcome Measures
Name Time Method The absence of oral/GI severe regimen related toxicities (oral/GI SRRT). 21 Days
- Secondary Outcome Measures
Name Time Method Time to neutrophil engraftment 21 Days Duration of oral/GI SRRT 21 Days Symptom burden per MD Anderson Symptom Inventory (MDASI) 21 Days Duration of febrile neutropenia 21 Days
Trial Locations
- Locations (28)
Emory University - Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
University Of Maryland School Of Medicine
🇺🇸Baltimore, Maryland, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
The Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Weill Cornell Medical College/New York Presbyterian Hospital
🇺🇸New York, New York, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Medstar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
UC San Diego Moores Cancer Center
🇺🇸San Diego, California, United States
Sarah Cannon Research Institute, Colorado
🇺🇸Denver, Colorado, United States
University of Minnesota Medical Center, Fairview
🇺🇸Minneapolis, Minnesota, 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
Indiana University Simon Comprehensive Cancer Center
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, 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
UC Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States