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

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ClinicalTrials.gov Identifier: NCT05181540
Recruitment Status : Recruiting
First Posted : January 6, 2022
Last Update Posted : May 13, 2022
Sponsor:
Information provided by (Responsible Party):
Angiocrine Bioscience

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Non Hodgkin Lymphoma Biological: AB-205 Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 21, 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: AB-205 plus standard-of-care preventive and supportive therapies. Biological: AB-205
Allogeneic genetically engineered human umbilical vein endothelial cells
Other Name: E-CEL cells
Placebo Comparator: Placebo plus standard-of-care preventive and supportive therapies. Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. The absence of oral/GI severe regimen related toxicities (oral/GI SRRT). [ Time Frame: 21 Days ]

Secondary Outcome Measures :
  1. Duration of oral/GI SRRT [ Time Frame: 21 Days ]
  2. Symptom burden per MD Anderson Symptom Inventory (MDASI) [ Time Frame: 21 Days ]
  3. Duration of febrile neutropenia [ Time Frame: 21 Days ]
  4. Time to neutrophil engraftment [ Time Frame: 21 Days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05181540


Contacts
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Contact: Gayle Bresnahan 877-784-8496 gbresnahan@angiocrinebio.com

Locations
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Sponsors and Collaborators
Angiocrine Bioscience
Investigators
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Study Director: Paul Finnegan, MD Angiocrine Bioscience, Inc.
More Information
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Responsible Party: Angiocrine Bioscience
ClinicalTrials.gov Identifier: NCT05181540    
Other Study ID Numbers: AB-205-301
First Posted: January 6, 2022    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angiocrine Bioscience:
Lymphoma
Cellular Therapy
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases