Hodgkin LymphomaPhase 2BRAPP2NCT02298283
Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD
A Phase 2 study testing brentuximab vedotin, Cyclophosphamide and Adriamycin in people with Hodgkin Lymphoma, run by The Lymphoma Academic Research Organisation at 30 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- brentuximab vedotin, Cyclophosphamide and Adriamycin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 30 sitesFrance
- Study dates
- Apr 2015to 9 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
- 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
- Patient affiliated to social security system
Who cannot join
- 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:
- Myocardial infarction within 2 years of inclusion
- New York Heart Association (NYHA) Class III or IV heart failure
Show all 17Show fewer
- 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
- 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
- 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
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
France30 sites
CH Victor Dupouy
Argenteuil, 95100
Polyclinique Bordeaux Nord
Bordeaux, 33300
Centre François Baclesse
Caen, 14076
CH de Chambéry
Chambéry, 73011
CH Sud Francilien
Corbeil-Essonnes, 91108
Hôpital Henri Mondor
Créteil, 94010
CHU de Dijon - Hôpital le Bocage
Dijon, 21034
Hôpital André Mignot
Le Chesnay, 78157
Clinique Victor Hugo
Le Mans, 72000
CHRU Lille - Hôpital Claude Huriez
Lille, 59037
CHU de Limoges
Limoges, 87042
Centre Léon Bérard
Lyon, 69008
Institut Paoli Calmette
Marseille, 13273
Hôpital de la Conception
Marseille, 13385
CHU Montpellier - Saint ELOI
Montpellier, 34295
CHU de Nantes
Nantes, 44093
Hôpital Cochin
Paris, 75004
Hôpital Saint Louis
Paris, 75475
Hôpital de la Pitié Salpétrière
Paris, 75651
CH Perpignan
Perpignan, 66046
Hôpital Haut Lévêque
Pessac, 33604
CHU Lyon Sud
Pierre-Bénite, 69495
CHU Robert Debre
Reims, 51092
CHU Pontchaillou
Rennes, 35033
Centre Henri Becquerel
Rouen, 76000
CHU de Strasbourg
Strasbourg, 67098
I.U.C.T Oncopole
Toulouse, 31059
CHU Bretonneau
Tours, 37044
CHU de Brabois
Vandœuvre-lès-Nancy, 54511
Gustave Roussy Cancer Campus
Villejuif, 94805
About this study
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
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).
Read the 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
- Conditions
- Hodgkin Lymphoma
- Being tested
- brentuximab vedotin, Cyclophosphamide, Adriamycin, Oncovin, Bleomycin
- Keywords
- Hodgkin lymphoma, HL, brentuximab vedotin
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brentuximab vedotinDrug
Also called SGN35
is 1.8 mg/kg administrated by IV infusion
CyclophosphamideDrug
1250 mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks
AdriamycinDrug
Also called Doxorubicin
35mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks
OncovinDrug
Also called Vincristin
1.4 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks
BleomycinDrug
10 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks
EtoposideDrug
200 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D3 of 2 BEACOPP cycles, every 3 weeks
ProcarbazineDrug
100 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks
PrednisoneDrug
40 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks
G-CSFDrug
5 µg/kg/j, SC, D9 until GB 1.0x109/L
30 GraysRadiation
30 Gy radiation of sites initially diagnoses + 6Gy for residual sites, 3 to 4 weeks after D1 of BEACOPP cycle 2.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: brentuximab vedotin; Drug: Cyclophosphamide; Drug: Adriamycin; Drug: Oncovin; Drug: Bleomycin; Drug: Etoposide; Drug: Procarbazine; Drug: Prednisone; Drug: G-CSF; Radiation: 30 Grays |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
Complete Response rate (CR rate)
according to Cheson 2007
Measured: 35 weeks
Overall survival
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startApr 2015
- Primary completion9 Jul 2020
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Lymphoma Academic Research Organisation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline BRICE, MD, Principal investigator, Lymphoma Study AssociationThomas GASTINNE, MD, Principal investigator, Lymphoma Study Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298283
- Sponsor's protocol ID
- BRAPP2
- Acronym
- BRAPP2
- Status last verified
- Jul 2021
- First submitted
- 13 Nov 2014
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02298283
- Acronym / sponsor ID
- BRAPP2 / BRAPP2
- Conditions
- Hodgkin Lymphoma
- Keywords
- Hodgkin lymphoma, HL, brentuximab vedotin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Lymphoma Academic Research OrganisationUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study treatment | Experimental | Drug: brentuximab vedotin, Drug: Cyclophosphamide, Drug: Adriamycin, Drug: Oncovin, Drug: Bleomycin, Drug: Etoposide, Drug: Procarbazine, Drug: Prednisone, Drug: G-CSF, Radiation: 30 Grays* 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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)
Key exclusion criteria (17 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brentuximab vedotinAlso: SGN35is 1.8 mg/kg administrated by IV infusion | Drug | study treatment |
| Cyclophosphamide1250 mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks | Drug | study treatment |
| AdriamycinAlso: Doxorubicin35mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks | Drug | study treatment |
| OncovinAlso: Vincristin1.4 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks | Drug | study treatment |
| Bleomycin10 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks | Drug | study treatment |
| Etoposide200 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D3 of 2 BEACOPP cycles, every 3 weeks | Drug | study treatment |
| Procarbazine100 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks | Drug | study treatment |
| Prednisone40 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks | Drug | study treatment |
| G-CSF5 µg/kg/j, SC, D9 until GB 1.0x109/L | Drug | study treatment |
| 30 Grays30 Gy radiation of sites initially diagnoses + 6Gy for residual sites, 3 to 4 weeks after D1 of BEACOPP cycle 2. | Radiation | study treatment |
Primary outcome
Progression free survival (PFS)
Time frame: 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.
2 secondary outcomes
Complete Response rate (CR rate)
Time frame: 35 weeks
Overall survival
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Hodgkin Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline BRICE, MD principal investigator
Lymphoma Study Association
Thomas GASTINNE, MD principal investigator
Lymphoma Study Association
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing brentuximab vedotin, Cyclophosphamide and Adriamycin in people with Hodgkin Lymphoma, run by The Lymphoma Academic Research Organisation at 30 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.