Clinical Trials /

Study on the Role of Brentuximab Vedotin as Single Agent in the Treatment of Relapsed/Refractory CD30+ PTCL Patients

NCT02497131

Description:

This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of Brentuximab Vedotin (BV) as a single agent in relapsed/refractory CD30+ PTCL patients.

Related Conditions:
  • Peripheral T-Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study on the Role of Brentuximab Vedotin as Single Agent in the Treatment of Relapsed/Refractory CD30+ PTCL Patients
  • Official Title: Phase II Study on the Role of Brentuximab Vedotin as Single Agent in the Treatment of Relapsed/Refractory CD30 Positive Peripheral T Cell Lymphoma (PTCL) Patients

Clinical Trial IDs

  • ORG STUDY ID: FIL_PTCL_BV
  • NCT ID: NCT02497131

Conditions

  • Lymphatic Diseases

Interventions

DrugSynonymsArms
Brentuximab VedotinSGN35Brentuximab Vedotin 16 cycles

Purpose

This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of Brentuximab Vedotin (BV) as a single agent in relapsed/refractory CD30+ PTCL patients.

Detailed Description

      BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of
      anti-cancer activity will be assessed using the revised response criteria for malignant
      lymphoma (Cheson et al. 2007).

      Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) and PET scan will be
      performed at baseline and Cycles 3, 8, 12, and 16. Patients will have an End of Treatment
      (EOT) assessment 30 ± 7 days after receiving their final dose of study drug. Patients with at
      least stable disease will enter short follow up phase till month 24 with radiology assessment
      every 6 months and visit every 12 weeks. After month 24 and for all patients with progressive
      disease, long-term follow-up assessments (including survival, disease status and next therapy
      information) will be performed every 12 weeks until either patient death or study closure,
      whichever occurs first.
    

Trial Arms

NameTypeDescriptionInterventions
Brentuximab Vedotin 16 cyclesExperimentalSubjects will receive 1.8 mg/kg of brentuximab vedotin as an iv infusion administered on Day 1 of each 21-day cycle for a maximum of 16 cycles.
  • Brentuximab Vedotin

Eligibility Criteria

        Inclusion Criteria:

          -  Signed written informed consent.

          -  Males and females ≥18 and ≤75 years at the time of enrolment.

          -  Histologically confirmed diagnosis of PTCL (PTCL-not otherwise specified [PTCL-NOS],
             angioimmunoblastic T cell lymphoma [AILT] and transformed mycosis fungoides) according
             to World Health Organization (2008) classification.

          -  Histologically confirmed CD30+ PTCL.

          -  Availability of histological material for central review and pathobiological studies.

          -  Failed at least one prior systemic antilymphoma therapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 at study
             entry.

          -  At least one site of disease measurable in two dimensions by computed tomography. Both
             nodal and extranodal disease will be considered (lymphnodes must have long axis of 1.5
             cm regardless of short axis or long axis 1.1 to 1.5 cm and short axis >1.0 cm).

          -  Hematology values within the following limits:

               -  Absolute neutrophil count (ANC) ≥ 1500/mm3 independent of growth factor support.

               -  Platelets ≥75,000/mm3 or ≥50,000/mm3 if bone marrow involvement is independent of
                  transfusion support.

               -  Hemoglobin level ≥8 g/dL.

          -  Biochemical values within the following limits:

               -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 x upper
                  limit of normal (ULN).

               -  Total bilirubin < 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome
                  or of nonhepatic origin).

               -  Serum creatinine ≤ 2 x ULN.

               -  Serum albumin ≥ 3 g/dL.

          -  Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7
             days of receiving study medication.

          -  WOCBP must agree to use effective contraception, defined as oral contraceptives,
             double barrier method or practice true abstinence from sexual intercourse during the
             study and for 6 months after the last dose of study drug.

          -  Male subjects and their female partners of childbearing potential must be willing to
             use an appropriate method of contraception or practice true abstinence from sexual
             intercourse during the study and for 6 months after the last dose of study drug.

        Exclusion Criteria:

          -  Diagnosis of CTCL, ALCL, mycosis fungoides or Sezary Syndrome.

          -  CD30 expression < 10 %.

          -  Patients that have not completed any prior treatment chemotherapy and/or other
             investigational agents within at least 5 half-lives of last dose of that prior
             treatment.

          -  Patients underwent major surgery without complete recovery

          -  Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient
             contained in the drug formulation of brentuximab vedotin.

          -  Any serious active disease or co-morbid medical condition (according to investigator's
             decision).

          -  Prior history of malignancies other than lymphoma (except for a history of a complete
             resection for basal cell or squamous cell carcinoma of the skin or carcinoma in situ
             of the cervix or breast) unless the subject has been free of the disease for ≥ 3
             years.

          -  Patients with peripheral neuropathy of grade 3-4 (also grade 2 with persistent pain,
             unresponsive to treatment).

          -  Signs or symptoms of progressive multifocal leukoencephalopathy (PML).

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          -  Pregnant or lactating females or men or women of childbearing potential not willing to
             use an adequate method of birth control for the duration of the study.

          -  CNS disease (meningeal and/or brain involvement by lymphoma) or testicular
             involvement.

          -  History of clinically relevant liver or renal insufficiency; significant cardiac,
             vascular pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic,
             hematologic, psychiatric, or metabolic disturbances.

          -  Known history of any of the following cardiovascular conditions:

               -  Myocardial infarction within 2 years from enrollment

               -  New York Heart Association (NYHA) Class III or IV heart failure

               -  Evidence of current uncontrolled cardiovascular conditions, including cardiac
                  arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic
                  evidence of acute ischemia or active conduction system abnormalities

               -  Recent evidence (within 6 months before first dose of study drug) of a
                  left-ventricular ejection fraction <50%

          -  Active opportunistic infection.

          -  Known history of Human Immunodeficiency Virus (HIV) or Hepatitis C or active infection
             with Hepatitis B.

          -  Prior allogeneic stem cell transplant.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:overall objective response rate (ORR)
Time Frame:1 year
Safety Issue:
Description:Overall objective response rate (ORR) is defined as the proportion of patients with complete remission (CR) or partial remission (PR) according to the Revised Response Criteria for Malignant Lymphoma

Secondary Outcome Measures

Measure:Duration of response
Time Frame:1 year
Safety Issue:
Description:Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to lymphoma
Measure:Complete remission rate (CR)
Time Frame:1 year
Safety Issue:
Description:The proportion of patients with complete remission (CR) according to the Revised Response Criteria for Malignant Lymphoma
Measure:Progression-free survival (PSF)
Time Frame:1 year
Safety Issue:
Description:Progression-free survival (PFS) is defined as the time from start of study treatment to first documentation of objective tumor progression or to death due to any cause
Measure:Overall survival (OS)
Time Frame:1 year
Safety Issue:
Description:Overall survival (OS) is defined as the time from start of study treatment to date of death due to any cause.
Measure:Adverse Events
Time Frame:1 year
Safety Issue:
Description:Type, incidence, severity, seriousness, and relatedness of adverse events, and laboratory abnormalities

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Fondazione Italiana Linfomi ONLUS

Trial Keywords

  • PTCL
  • CD30+

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