Clinical Trials /

Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD

NCT02298283

Description:

This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin's lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).

Related Conditions:
  • Classical Hodgkin Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD
  • Official Title: Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II Hodgkin's Lymphoma and FDG-PET Positivity After 2 Cycles of ABVD

Clinical Trial IDs

  • ORG STUDY ID: BRAPP2
  • NCT ID: NCT02298283

Conditions

  • Hodgkin Lymphoma

Interventions

DrugSynonymsArms
brentuximab vedotinSGN35study treatment
Cyclophosphamidestudy treatment
AdriamycinDoxorubicinstudy treatment
OncovinVincristinstudy treatment
Bleomycinstudy treatment
Etoposidestudy treatment
Procarbazinestudy treatment
Prednisonestudy treatment
G-CSFstudy treatment

Purpose

This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin's lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).

Detailed Description

      This study aims to evaluate the progression free survival after treatment for patient with
      stage I/II supradiaphragmatic HL patient and PET positive after 2 courses of ABVD.

      The treatment consist of 3 phases :

        -  induction treatment with 2 cycles every 3 weeks of bleomycin, etoposide, Adriamycin,
           cyclophosphamide, oncovin, procarbazine, and prednisone (BEACOPP) escalated

        -  radiotherapy 30 Gy starting 3 to 4 weeks after last day of second course of
           BEACOPP-escalated

        -  consolidation treatment with 8 cycles every 21 days of brentuximab vedotin
    

Trial Arms

NameTypeDescriptionInterventions
study treatmentExperimentalinduction = BEACOPP-escalated (bleomycin, etoposide, adriamycin, cyclophosphamide, oncovin, procarbazine, and prednisone) : 2 cycles every 3 weeks radiotherapy = involved field radiotherapy (IFRT) will be given 3 to 4 weeks after the last day of second BEACOPP at 30 Grays (+boost 6 Grays to area with residual lesion) in 3 weeks Consolidation = brentuximab vedotin treatment will start 4 weeks after the last day of IFRT and up to 6 weeks. The dose of study treatment is 1.8 mg/kg
  • brentuximab vedotin
  • Cyclophosphamide
  • Adriamycin
  • Oncovin
  • Bleomycin
  • Etoposide
  • Procarbazine
  • Prednisone
  • G-CSF

Eligibility Criteria

        Inclusion Criteria:

          1. Patients must have histologically confirmed cluster of differentiation antigen 30+
             (CD30+) classical Hodgkin lymphoma

          2. Patients must have provided voluntary written informed consent

          3. Supradiaphragmatic Ann Arbor clinical stage I or II

          4. Mandatory PET scan performed at diagnosis

          5. Patients treated with first-line ABVD and PET scan positive after 2 cycles (Deauville
             score 4 & 5)

          6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
             0-2

          7. Life expectancy > 6 months

          8. Patients must be 18-65 years of age

          9. Patients must be available for periodic blood sampling, study-related assessments and
             management of toxicity at the treating institution

         10. Female patients who:

               -  Are postmenopausal for at least 1 year before the screening visit OR are
                  surgically sterile OR

               -  If they are of childbearing potential, agree to practice 2 effective methods of
                  contraception at the same time

         11. Male patients, even if surgically sterilized, who agree to practice effective barrier
             contraception during the entire study treatment period and through 6 months after the
             last dose of study drug, or agree to completely abstain from heterosexual intercourse

         12. Clinical laboratory values as specified below before the first dose of study drug:

               -  Absolute neutrophil count ≥ 1,500/µL

               -  Platelet count ≥ 75,000/ µL

               -  Total bilirubin must be < 1.5 x the upper limit of the normal (ULN) unless the
                  elevation is known to be due to Gilbert syndrome

               -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)must be < 3 x
                  the upper limit of the normal range

               -  Serum creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated
                  creatinine clearance > 40 mL/minute

               -  Hemoglobin must be ≥ 8g/dL

         13. Patient affiliated to social security system

        Exclusion Criteria:

          1. Patients with dementia or altered mental status that would preclude compliance with
             drug delivery

          2. Women who are pregnant or breastfeeding

          3. Patients with symptomatic pulmonary disease

          4. Patients with known history of any of the following cardiovascular conditions:

               -  Myocardial infarction within 2 years of inclusion

               -  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%

          5. Any history of cancer or cancer treatment during the last 3 years with the exception
             of non-melanoma skin cancer or stage 0 (in situ) carcinoma of any type if they have
             undergone complete resection

          6. Uncontrolled infectious disease, including active Hepatitis B Virus (HBV) infection
             defined by either detection of Hepatitis B surface (HBs) Antigen or presence of
             Hepatitis B core (HBc) antibody without detectable anti HBs antibody

          7. Any active systemic viral, bacterial, or fungal infection requiring systemic
             antibiotics at the time of inclusion and planned to be still on going within 2 weeks
             prior to first study drug dose

          8. Known Human Immunodeficiency Virus (HIV), known or suspected hepatitis C Virus (HCV)
             or human T-cell lymphotrophic virus (HTLV) serology positivity

          9. Patients who have been treated previously with any anti-CD30 antibody

         10. Known hypersensitivity to any excipients contained in the brentuximab vedotin
             formulation

         11. Known cerebral or meningeal disease (HL or any other etiology), including signs or
             symptoms of Progressive Multifocal Leukoencephalopathy (PML)

         12. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2

         13. 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
      
Maximum Eligible Age:65 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression free survival (PFS)
Time Frame:2 years
Safety Issue:
Description:PFS is defined as the time from the date of the first cycle of ABVD to the first observation of documented disease progression or death due to any cause.

Secondary Outcome Measures

Measure:Complete Response rate (CR rate)
Time Frame:35 weeks
Safety Issue:
Description:according to Cheson 2007
Measure:Overall survival
Time Frame:4 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:The Lymphoma Academic Research Organisation

Trial Keywords

  • Hodgkin lymphoma
  • HL
  • brentuximab vedotin

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