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BRAPP2: Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD

Sponsor
The Lymphoma Academic Research Organisation (Other)
Overall Status
Completed
CT.gov ID
NCT02298283
Collaborator
(none)
40
Enrollment
30
Locations
1
Arm
63.3
Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

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

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Jul 9, 2020
Actual Study Completion Date :
Jul 9, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: study treatment

induction = 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

Drug: brentuximab vedotin
is 1.8 mg/kg administrated by IV infusion
Other Names:
  • SGN35

    • Drug: Cyclophosphamide
    1250 mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks

    Drug: Adriamycin
    35mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks
    Other Names:
  • Doxorubicin

    • Drug: Oncovin
    1.4 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks
    Other Names:
  • Vincristin

    • Drug: Bleomycin
    10 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks

    Drug: Etoposide
    200 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D3 of 2 BEACOPP cycles, every 3 weeks

    Drug: Procarbazine
    100 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks

    Drug: Prednisone
    40 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks

    Drug: G-CSF
    5 µg/kg/j, SC, D9 until GB 1.0x109/L

    Radiation: 30 Grays
    30 Gy radiation of sites initially diagnoses + 6Gy for residual sites, 3 to 4 weeks after D1 of BEACOPP cycle 2.

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival (PFS) [2 years]

      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

    1. Complete Response rate (CR rate) [35 weeks]

      according to Cheson 2007

    2. Overall survival [4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. 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

    2. 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

    1. 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%

    1. 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

    2. 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

    3. 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

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

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

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

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

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

    9. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CH Victor Dupouy Argenteuil France 95100
    2 Polyclinique Bordeaux Nord Bordeaux France 33300
    3 Centre François Baclesse Caen France 14076
    4 CH de Chambéry Chambéry France 73011
    5 CH Sud Francilien Corbeil-Essonnes France 91108
    6 Hôpital Henri Mondor Creteil France 94010
    7 CHU de Dijon - Hôpital le Bocage Dijon France 21034
    8 Hôpital André Mignot Le Chesnay France 78157
    9 Clinique Victor Hugo Le Mans France 72000
    10 CHRU Lille - Hôpital Claude Huriez Lille France 59037
    11 CHU de Limoges Limoges France 87042
    12 Centre Léon Bérard Lyon France 69008
    13 Institut Paoli Calmette Marseille France 13273
    14 Hôpital de la Conception Marseille France 13385
    15 CHU Montpellier - Saint ELOI Montpellier France 34295
    16 CHU de Nantes Nantes France 44093
    17 Hôpital Saint Louis Paris cedex 10 France 75475
    18 Hôpital Cochin Paris France 75004
    19 Hôpital de la Pitié Salpétrière Paris France 75651
    20 CH Perpignan Perpignan France 66046
    21 Hôpital Haut Lévêque Pessac France 33604
    22 CHU Lyon Sud Pierre Bénite Cedex France 69495
    23 CHU Robert Debre Reims France 51092
    24 CHU Pontchaillou Rennes France 35033
    25 Centre Henri Becquerel Rouen France 76000
    26 CHU de Strasbourg Strasbourg France 67098
    27 I.U.C.T Oncopole Toulouse France 31059
    28 CHU Bretonneau Tours France 37044
    29 CHU de Brabois Vandœuvre-lès-Nancy France 54511
    30 Gustave Roussy Cancer Campus Villejuif France 94805

    Sponsors and Collaborators

    • The Lymphoma Academic Research Organisation

    Investigators

    • Principal Investigator: Pauline BRICE, MD, Lymphoma Study Association
    • Principal Investigator: Thomas GASTINNE, MD, Lymphoma Study Association

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Lymphoma Academic Research Organisation
    ClinicalTrials.gov Identifier:
    NCT02298283
    Other Study ID Numbers:
    • BRAPP2
    First Posted:
    Nov 21, 2014
    Last Update Posted:
    Jul 26, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by The Lymphoma Academic Research Organisation
    Hodgkin lymphoma
    HL
    brentuximab vedotin
    Additional relevant MeSH terms:
    Lymphoma
    Hodgkin Disease
    Prednisone
    Cyclophosphamide
    Doxorubicin
    Etoposide
    Liposomal doxorubicin
    Vincristine
    Bleomycin
    Brentuximab Vedotin
    Procarbazine

    Study Results

    No Results Posted as of Jul 26, 2021