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).
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
Interventions
Drug | Synonyms | Arms |
---|
brentuximab vedotin | SGN35 | study treatment |
Cyclophosphamide | | study treatment |
Adriamycin | Doxorubicin | study treatment |
Oncovin | Vincristin | study treatment |
Bleomycin | | study treatment |
Etoposide | | study treatment |
Procarbazine | | study treatment |
Prednisone | | study treatment |
G-CSF | | study 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
Name | Type | Description | Interventions |
---|
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 | - 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: | Completed |
Lead Sponsor: | The Lymphoma Academic Research Organisation |
Trial Keywords
- Hodgkin lymphoma
- HL
- brentuximab vedotin
Last Updated
July 26, 2021