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Trial record 1 of 1 for:    A Phase 1, Open Label, Non-randomized, Multi-Center Trial of AB-205 in Adults with Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation
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Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT03925935
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
Angiocrine Bioscience

Brief Summary:
A phase 1, open label, multi-center trial of AB-205 in adults with Hodgkin or non-Hodgkin lymphoma who are in chemo-sensitive remission undergoing high-dose therapy, with or without radiation, and autologous stem cell transplantation (HDT-ASCT). Subjects will receive AB-205 infusion following autologous stem cell transfusion on Day 0.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Non-hodgkin Lymphoma Biological: AB-205 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Sequential Assignment
Intervention Model Description: AB-205 dose escalation based on safety.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Non-randomized, Multi-Center Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Experimental
Up to 3 sequential dose escalation cohorts of AB-205
Biological: AB-205
Engineered human umbilical vein endothelial cells




Primary Outcome Measures :
  1. Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5 [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5 [ Time Frame: 100 days ]
  2. Severity and duration of grade ≥ 3 mucosal toxicities including oropharyngeal mucositis, nausea, vomiting, and/or diarrhea. [ Time Frame: Day 0 to hospital discharge ]
  3. Time to neutrophil engraftment [ Time Frame: First of three consecutive days after ASCT of absolute neutrophil count (ANC) > 500/μL ]
  4. Time to platelet engraftment [ Time Frame: First of seven consecutive days after ASCT of platelet count ≥ 20,000/μL without transfusion support ]
  5. Time to lymphoid recovery [ Time Frame: 14, 28 and 100 days post-ASCT ]
  6. Progression-free survival [ Time Frame: 100 and 365 days post-ASCT ]
  7. Non-relapse mortality [ Time Frame: 100 and 365 days post-ASCT ]
  8. Overall survival [ Time Frame: 100 and 365 days post-ASCT ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) who are candidates for HDT-ASCT with one of the following conditioning regimens:

    • carmustine, etoposide, cytarabine, melphalan (BEAM)
    • cyclophosphamide, carmustine, etoposide (CBV)
    • thiotepa, busulphan, cyclophosphamide (TBC)
    • additional myeloablative chemotherapy-based conditioning regimens may be permitted with the approval of the medical monitor
  • Adjunct radiation therapy to HDT will be allowed.
  • Adequate organ function is required, defined as follows:

    • Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia
    • AST, ALT, and alkaline phosphatase < 3 times the upper limit of normal
    • Creatinine clearance ≥ 40 ml/min (calculated by Cockcroft Gault)
    • LVEF ≥ 45% by MUGA or resting echocardiogram
    • Pulmonary function (FEV1 and corrected DLCO) ≥ 45% predicted
    • Adequate performance status ECOG ≤1
  • For female subjects of childbearing potential:

    • A negative serum or urine pregnancy test at screening.
    • Subject must be willing to use a recommended method of contraception from the start of the screening period and throughout the study period.
  • For males who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception:

    - Subject must be willing to use a recommended method of contraception and refrain from sperm donation from the start of conditioning therapy for at least 1 year after completion and discussion with a treating physician.

  • Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
  • Ability to provide written informed consent.

EXCLUSION CRITERIA

  • History of prior ASCT.
  • Active malignancy other than the one for which the subject is undergoing HDT-ASCT. (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.
  • Active Human Immunodeficiency Virus (HIV) infection and Acquired Immunodeficiency Syndrome (AIDS).
  • Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 30 days or longer after chemotherapy treatment discontinuation if required by prescribing information for chemotherapy agents received during the study.
  • 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 place the subject at increased risk for toxicity by participation in the study.

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): NCT03925935


Contacts
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Contact: Gayle Bresnahan 858-220-1046 gbresnahan@angiocrinebio.com
Contact: John Jaskowiak 408-646-2265 jjaskowiak@angiocrinebio.com

Locations
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United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Karen Rickard       krickard@coh.org   
Principal Investigator: Elizabeth Budde, MD         
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Lam Nguyen       lkng@ucdavis.edu   
Principal Investigator: Mehrdad Abedi, MD         
UC San Diego Moores Cancer Center Not yet recruiting
San Diego, California, United States, 92093
Principal Investigator: Carolyn Mulroney, MD         
The University of California San Francisco Not yet recruiting
San Francisco, California, United States, 94117
Principal Investigator: Bita Fakhri, MD         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Attaphol Pawarode, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michael Scordo, MD    212-639-6052      
Principal Investigator: Michael Scordo, MD         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Channing V. Dudley, RN, BSN, MSN    615-875-8757    channing.v.dudley@vumc.org   
Principal Investigator: Bhagirathbhai Dholaria, MBBS         
United States, Texas
MD Anderson Not yet recruiting
Houston, Texas, United States, 77030
Principal Investigator: Muzaffar Qazilbash, MD         
Sponsors and Collaborators
Angiocrine Bioscience
California Institute for Regenerative Medicine (CIRM)
Investigators
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Study Director: Edward Kavalerchik, MD Angiocrine Bioscience

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Responsible Party: Angiocrine Bioscience
ClinicalTrials.gov Identifier: NCT03925935     History of Changes
Other Study ID Numbers: AB-205-001
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
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
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases