Status:
COMPLETED
Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma.
Lead Sponsor:
The Lymphoma Academic Research Organisation
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with an unfavorable diagnosis,...
Detailed Description
Patients will receive either ABVD chemotherapy (standard treatment = doxorubicin, bleomycin, vinblastine, dacarbazine) or the Brentuximab vedotin in combination with chemotherapy AVD (study treatment)...
Eligibility Criteria
Inclusion
- Histologically confirmed CD30+ classical Hodgkin lymphoma
- Supradiaphragmatic Ann Arbor clinical stage I or II
- Previously untreated
- PET scan without IV contrast at diagnosis available for central review with at least one hypermetabolic lesion
- Unfavourable (U) characteristics according to the classic EORTC/LYSA clinical prognostic factors, including patients with at least one of the following factors:
- CSII ≥ 4 nodal areas
- age ≥ 50 yrs
- M/T ratio ≥ 0.35
- ESR ≥ 50 (without B-symptoms) or ESR ≥ 30 with B-symptoms
- ECOG performance status 0-2
- Life expectancy \> 6 months
- Age 18 to 60 years
- Availability 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, through 6 months after the last dose of study drug, OR agree to completely abstain from heterosexual intercourse
- Male patients, even if surgically sterilized (ie, status postvasectomy), who:
- o 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.
- Written informed consent.
- Required baseline laboratory data:
- Absolute neutrophil count ≥ 1,500/µL
- Platelet count ≥ 75,000/ µL
- Hemoglobin ≥ 8g/dL
- Serum total bilirubin ≤ 1.5 X ULN unless the elevation is known to be due to Gilbert syndrome.
- Serum creatinine ≤ 2.0 mg/dL and/or calculated creatinine clearance \> 40 mL/minute (Cockcroft-Gault formula or MDRD)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 X ULN
Exclusion
- Histological diagnosis different from classical Hodgkin Lymphoma. Nodular lymphocyte predominant subtypes (nodular paragranuloma or Poppema paragranuloma) are excluded.
- Known cerebral or meningeal disease of any etiology, including signs or symptoms of PML
- Any sensory or motor peripheral neuropathy ≥ Grade 2
- Known history of any of the following cardiovascular conditions
- Myocardial infarction within 2 years of randomization
- New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 14)
- 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 30 days before first dose of study drug) of a left-ventricular ejection fraction \<50%
- Unstable diabetes mellitus (to avoid uninterpretable FDG-PET scan).
- Known HIV positive
- HCV positive
- HBV positive. This means:
- HBsAg positive
- HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA (HBsAg negative patients and viral DNA negative and patients seropositive due to a history of hepatitis B vaccine are eligible).
- Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors. Carcinoma in situ of any type not excluded if complete resection.
- Dementia or altered mental status
- Pregnancy or breastfeeding.
- Previous treatment with any anti-CD30 antibody.
- Known hypersensitivity to any excipients contained in the BV formulation or known contra-indication to any drug contained in the chemotherapy regimens
- Treatment with corticosteroids before baseline PET scan
- Known active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy or with untreated known active Grade 3 viral, bacterial, or fungal infection, within 2 weeks prior to the first dose of BV
- Treatment with any investigational drug within 30 days before first cycle of treatment
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2022
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT02292979
Start Date
March 1 2015
End Date
June 2 2022
Last Update
August 19 2022
Active Locations (65)
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1
ZNA Middelheim
Antwerp, Belgium
2
ZNA Stuivenberg
Antwerp, Belgium
3
A.Z. Sint Jan AV
Bruges, Belgium
4
Institut Jules Bordet
Brussels, Belgium