Clinical Trial 21412

• Overview

  Study 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)

  Summary:

  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.

  Objective:

  Primary: To demonstrate a reduction in the incidence and severity of regimen related toxicities with AB-205 plus standard of care (SoC) versus placebo plus SoC in adults with lymphoma undergoing HDT-AHCT. Secondary: To assess the efficacy of AB-205 versus placebo in adults with lymphoma undergoing HDT AHCT. To assess the safety of AB-205 in adults with lymphoma undergoing HDT-AHCT.

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunotherapy

  Medications:

  AB-205 (); Acyclovir (); Alkeran (Melphalan); Aprepitant (); Bendamustine (); Carmustine (); Cytarabine (Cytosine Arabinoside); Dexamethasone (); Fluconazole (); Melphalan (); Ondansetron (); Placebo (); Zofran (Ondansetron); etoposide ()

• Inclusion 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 > Serum bilirubin (total: direct and inderect) > AST, ALT, and alkaline phosphatase > Creatinine clearance >30 ml/min (calculated by Cockcroft Gault)
  • LVEF >40% 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 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.
  • Additional criteria will apply

• Exclusion Criteria

  Exclusion Criteria:
  • History of prior HCT
  • Primary CNS lymphoma
  • 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 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 or myeloablative conditioning regimens other than BEAM or BeEAM

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