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

NCT02298283 | Completed Phase 2 DMC

• 1 other identifier: BRAPP2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 30

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).

Conditions

Hodgkin Lymphoma

Keywords

Hodgkin lymphoma; HL; brentuximab vedotin

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  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.

  2 years

Secondary Outcomes (2)

• Complete Response rate (CR rate)

  35 weeks

• Overall survival

  4 years

Study Arms (1)

study treatment

EXPERIMENTAL

* 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; Drug: Cyclophosphamide; Drug: Adriamycin; Drug: Oncovin; Drug: Bleomycin; Drug: Etoposide; Drug: Procarbazine; Drug: Prednisone; Drug: G-CSF; Radiation: 30 Grays

Interventions

brentuximab vedotin DRUG

is 1.8 mg/kg administrated by IV infusion

Also known as: SGN35

study treatment

Cyclophosphamide DRUG

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

study treatment

Adriamycin DRUG

35mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks

Also known as: Doxorubicin

study treatment

Oncovin DRUG

1.4 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks

Also known as: Vincristin

study treatment

Bleomycin DRUG

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

study treatment

Etoposide DRUG

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

study treatment

Procarbazine DRUG

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

study treatment

Prednisone DRUG

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

study treatment

G-CSF DRUG

5 µg/kg/j, SC, D9 until GB 1.0x109/L

study treatment

30 Grays RADIATION

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

study treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed cluster of differentiation antigen 30+ (CD30+) classical Hodgkin lymphoma
• Patients must have provided voluntary written informed consent
• Supradiaphragmatic Ann Arbor clinical stage I or II
• Mandatory PET scan performed at diagnosis
• Patients treated with first-line ABVD and PET scan positive after 2 cycles (Deauville score 4 \& 5)
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Life expectancy \> 6 months
• Patients must be 18-65 years of age
• Patients must be available for periodic blood sampling, study-related assessments and management of toxicity at the treating institution
• 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
• 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
• Clinical laboratory values as specified below before the first dose of study drug:
• Absolute neutrophil count ≥ 1,500/µL

You may not qualify if:

• Patients with dementia or altered mental status that would preclude compliance with drug delivery
• Women who are pregnant or breastfeeding
• Patients with symptomatic pulmonary disease
• Patients with known history of any of the following cardiovascular conditions:
• 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%
• 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
• 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
• Known Human Immunodeficiency Virus (HIV), known or suspected hepatitis C Virus (HCV) or human T-cell lymphotrophic virus (HTLV) serology positivity
• Patients who have been treated previously with any anti-CD30 antibody
• Known hypersensitivity to any excipients contained in the brentuximab vedotin formulation
• Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencephalopathy (PML)
• Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
• 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

Sponsors & Collaborators

• The Lymphoma Academic Research Organisation: lead

Study Sites (30)

CH Victor Dupouy

Argenteuil, 95100, France

Location

Polyclinique Bordeaux Nord

Bordeaux, 33300, France

Location

Centre François Baclesse

Caen, 14076, France

Location

CH de Chambéry

Chambéry, 73011, France

Location

CH Sud Francilien

Corbeil-Essonnes, 91108, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU de Dijon - Hôpital le Bocage

Dijon, 21034, France

Location

Hôpital André Mignot

Le Chesnay, 78157, France

Location

Clinique Victor Hugo

Le Mans, 72000, France

Location

CHRU Lille - Hôpital Claude Huriez

Lille, 59037, France

Location

CHU de Limoges

Limoges, 87042, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Paoli Calmette

Marseille, 13273, France

Location

Hôpital de la Conception

Marseille, 13385, France

Location

CHU Montpellier - Saint ELOI

Montpellier, 34295, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Hôpital Cochin

Paris, 75004, France

Location

Hôpital Saint Louis

Paris, 75475, France

Location

Hôpital de la Pitié Salpétrière

Paris, 75651, France

Location

CH Perpignan

Perpignan, 66046, France

Location

Hôpital Haut Lévêque

Pessac, 33604, France

Location

CHU Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU Robert Debre

Reims, 51092, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

Centre Henri Becquerel

Rouen, 76000, France

Location

CHU de Strasbourg

Strasbourg, 67098, France

Location

I.U.C.T Oncopole

Toulouse, 31059, France

Location

CHU Bretonneau

Tours, 37044, France

Location

CHU de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Gustave Roussy Cancer Campus

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Brentuximab Vedotin; Cyclophosphamide; Doxorubicin; Vincristine; Bleomycin; Etoposide; Procarbazine; Prednisone; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Glycopeptides; Glycoconjugates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Colony-Stimulating Factors; Glycoproteins; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Biological Factors

Study Officials

• Pauline BRICE, MD

  Lymphoma Study Association

  PRINCIPAL INVESTIGATOR

• Thomas GASTINNE, MD

  Lymphoma Study Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 21, 2014
• Study Start: April 1, 2015
• Primary Completion: July 9, 2020
• Study Completion: July 9, 2020
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (30)