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

Primary Purpose

Hodgkin Lymphoma, Non Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AB-205
Placebo
Sponsored by
Angiocrine Bioscience
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hodgkin Lymphoma focused on measuring Lymphoma, Cellular Therapy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner MD Anderson Cancer CenterRecruiting
  • City of Hope Comprehensive Cancer CenterRecruiting
  • University of California, Los AngelesRecruiting
  • UC Davis Comprehensive Cancer CenterRecruiting
  • UC San Diego Moores Cancer CenterRecruiting
  • Sarah Cannon Research Institute, ColoradoRecruiting
  • University of Miami - Sylvester Comprehensive Cancer CenterRecruiting
  • University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research InstituteRecruiting
  • Emory University - Winship Cancer InstituteRecruiting
  • University of Illinois Cancer CenterRecruiting
  • University of Iowa Hospitals & ClinicsRecruiting
  • University Of Maryland School Of MedicineRecruiting
  • Massachusetts General HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • University of MichiganRecruiting
  • University of Minnesota Medical Center, FairviewRecruiting
  • Hackensack University Medical CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Weill Cornell Medical College/New York Presbyterian HospitalRecruiting
  • The Ohio State University Comprehensive Cancer CenterRecruiting
  • Oregon Health and Science UniversityRecruiting
  • Fox Chase Cancer CenterRecruiting
  • Sarah Cannon Research Institute, NashvilleRecruiting
  • Vanderbilt-Ingram Cancer CenterRecruiting
  • The University of Texas MD Anderson Cancer CenterRecruiting
  • Fred Hutchinson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AB-205 plus standard-of-care preventive and supportive therapies.

Placebo plus standard-of-care preventive and supportive therapies.

Arm Description

Outcomes

Primary Outcome Measures

The absence of oral/GI severe regimen related toxicities (oral/GI SRRT).

Secondary Outcome Measures

Duration of oral/GI SRRT
Symptom burden per MD Anderson Symptom Inventory (MDASI)
Duration of febrile neutropenia
Time to neutrophil engraftment

Full Information

First Posted
December 16, 2021
Last Updated
October 20, 2023
Sponsor
Angiocrine Bioscience
Collaborators
California Institute for Regenerative Medicine (CIRM)
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1. Study Identification

Unique Protocol Identification Number
NCT05181540
Brief Title
A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angiocrine Bioscience
Collaborators
California Institute for Regenerative Medicine (CIRM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Non Hodgkin Lymphoma
Keywords
Lymphoma, Cellular Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AB-205 plus standard-of-care preventive and supportive therapies.
Arm Type
Experimental
Arm Title
Placebo plus standard-of-care preventive and supportive therapies.
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
AB-205
Other Intervention Name(s)
E-CEL cells
Intervention Description
Allogeneic genetically engineered human umbilical vein endothelial cells
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
The absence of oral/GI severe regimen related toxicities (oral/GI SRRT).
Time Frame
21 Days
Secondary Outcome Measure Information:
Title
Duration of oral/GI SRRT
Time Frame
21 Days
Title
Symptom burden per MD Anderson Symptom Inventory (MDASI)
Time Frame
21 Days
Title
Duration of febrile neutropenia
Time Frame
21 Days
Title
Time to neutrophil engraftment
Time Frame
21 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gayle Bresnahan
Phone
877-784-8496
Email
gbresnahan@angiocrinebio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Finnegan, MD
Organizational Affiliation
Angiocrine Bioscience, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klarissa Jones
Phone
602-747-3647
Email
Klarissa.Jones@bannerhealth.com
First Name & Middle Initial & Last Name & Degree
Rajneesh Nath, MD
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffrey Shouse, MD
Phone
877-467-3411
Email
gshouse@coh.org
First Name & Middle Initial & Last Name & Degree
Geoffrey Shouse, MD
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruck Habtemariam
Phone
310-794-0242
Email
BHabtemariam@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Monica Mead, MD
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Mellor, CCRC
Email
ljmellor@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Mehrdad Abedi, MD
Facility Name
UC San Diego Moores Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Padilla
Phone
858-822-5634
Email
mlp002@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Carolyn Mulroney, MD
Facility Name
Sarah Cannon Research Institute, Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luke Mountjoy, DO
Phone
720-754-4800
Email
Luke.Mountjoy@HealthONEcares.com
First Name & Middle Initial & Last Name & Degree
Luke Mountjoy, DO
Facility Name
University of Miami - Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yolanda Davis
Phone
305-243-0494
Email
y.p.davis@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Amer Beitinjaneh, MD
Facility Name
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9416
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
Protocolreporting2@moffitt.org
First Name & Middle Initial & Last Name & Degree
Farhad Khimani, MD
Facility Name
Emory University - Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline Newlands
Phone
404-778-5124
Email
pnewlan@emory.edu
First Name & Middle Initial & Last Name & Degree
Jason Romancik, MD
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annette Kinsella
Phone
312-996-5931
Email
annettek@uic.edu
First Name & Middle Initial & Last Name & Degree
Chukwuemeka Uzoka, MD
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Parrott, RN
Phone
319-353-6347
Email
karen-parrott@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Umar Farooq, MD
Facility Name
University Of Maryland School Of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Kim, RN, BSN
Phone
410-328-7339
Email
EstherKim@umm.edu
First Name & Middle Initial & Last Name & Degree
Nancy Hardy, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachariah DeFilipp, MD
Phone
617-726-5765
Email
zdefilpp@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Zachariah DeFilipp, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavania Elavalakanar
Phone
617-667-1903
Email
pelavala@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jon Arnason, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Attaphol Pawarode, MD
Facility Name
University of Minnesota Medical Center, Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mai Thao
Email
thaox451@umn.edu
First Name & Middle Initial & Last Name & Degree
Daniel O'Leary, MD
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Rowley, MD
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Scordo, MD
Phone
646-608-3771
First Name & Middle Initial & Last Name & Degree
Michael Scordo, MD
Facility Name
Weill Cornell Medical College/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Mitto
Phone
646-962-7272
Email
ram9073@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Tsiporah Shore, MD
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John McCarthy
Phone
614-685-0808
Email
John.McCarthy@osumc.edu
First Name & Middle Initial & Last Name & Degree
Evandro Bezerra, MD
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariana Montoya
Phone
503-418-9382
Email
montoyaa@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Joseph Bubalo, PharmD, BCPS, BCOP
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rashmi Khanal, MD
Facility Name
Sarah Cannon Research Institute, Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Cannon Research
Phone
615-329-7274
First Name & Middle Initial & Last Name & Degree
Jeremy Pantin, MD
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
800-811-8480
Email
cip@vumc.org
First Name & Middle Initial & Last Name & Degree
Bhagirathbhai Dholaria, MBBS
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Parker
Phone
713-745-3219
Email
CR_Study_Registration@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Muzaffar Qazilbash, MD
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Gauthier, MD
Email
jgauthier@fredhutch.org
First Name & Middle Initial & Last Name & Degree
Jordan Gauthier, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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