Clinical Trials /

Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation

NCT03925935

Description:

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.

Related Conditions:
  • Hodgkin Lymphoma
  • Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation
  • 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

Clinical Trial IDs

  • ORG STUDY ID: AB-205-001
  • NCT ID: NCT03925935

Conditions

  • Hodgkin Lymphoma
  • Non-hodgkin Lymphoma

Interventions

DrugSynonymsArms
AB-205Experimental

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
ExperimentalExperimentalUp to 3 sequential dose escalation cohorts of AB-205
  • AB-205

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5
Time Frame:24 hours
Safety Issue:
Description:

Secondary Outcome Measures

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Angiocrine Bioscience

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