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

Hodgkin Lymphoma Clinical Trial

— E-CELERATE  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05181540
• Other study ID #: AB-205-301
• Status: Terminated
• Phase: Phase 3
• Start date: February 21, 2022
• Est. completion date: January 24, 2024

Study information

• Verified date: January 2024
• Source: Angiocrine Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: January 24, 2024
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Lymphoma
• Lymphoma
• Non Hodgkin Lymphoma

Intervention

Biological:
• AB-205
Allogeneic genetically engineered human umbilical vein endothelial cells

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University - Winship Cancer Institute	Atlanta	Georgia
United States	University Of Maryland School Of Medicine	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Illinois Cancer Center	Chicago	Illinois
United States	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Sarah Cannon Research Institute, Colorado	Denver	Colorado
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Simon Comprehensive Cancer Center	Indianapolis	Indiana
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Miami - Sylvester Comprehensive Cancer Center	Miami	Florida
United States	University of Minnesota Medical Center, Fairview	Minneapolis	Minnesota
United States	Sarah Cannon Research Institute, Nashville	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
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	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	UC Davis Comprehensive Cancer Center	Sacramento	California
United States	UC San Diego Moores Cancer Center	San Diego	California
United States	Fred Hutchinson Cancer Center	Seattle	Washington
United States	University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Angiocrine Bioscience	California Institute for Regenerative Medicine (CIRM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The absence of oral/GI severe regimen related toxicities (oral/GI SRRT).		21 Days
Secondary	Duration of oral/GI SRRT		21 Days
Secondary	Symptom burden per MD Anderson Symptom Inventory (MDASI)		21 Days
Secondary	Duration of febrile neutropenia		21 Days
Secondary	Time to neutrophil engraftment		21 Days