Clinical trial NCT05181540: A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hodgkin Lymphoma
Non Hodgkin Lymphoma
Keywords: Lymphoma
Cellular Therapy
Lead sponsor: Angiocrine Bioscience
Sponsor class: INDUSTRY
Collaborators: name: California Institute for Regenerative Medicine (CIRM)
First posted: 2022-01-06
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: The absence of oral/GI severe regimen related toxicities (oral/GI SRRT).
timeFrame: 21 Days
Secondary outcomes:
measure: Duration of oral/GI SRRT
timeFrame: 21 Days
measure: Symptom burden per MD Anderson Symptom Inventory (MDASI)
timeFrame: 21 Days
measure: Duration of febrile neutropenia
timeFrame: 21 Days
measure: Time to neutrophil engraftment
timeFrame: 21 Days
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: San Diego
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Denver
country: United States
facility: Sarah Cannon Research Institute, Colorado
state: Colorado
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Miami
country: United States
facility: University of Miami - Sylvester Comprehensive Cancer Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University - Winship Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: University of Illinois Cancer Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Simon Comprehensive Cancer Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Baltimore
country: United States
facility: University Of Maryland School Of Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Fairview
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College/New York Presbyterian Hospital
state: New York
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute, Nashville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
Study officials:
affiliation: Angiocrine Bioscience, Inc.
name: Paul Finnegan, MD
role: STUDY_DIRECTOR
References: