Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma
- Conditions
- Advanced Classical Hodgkin LymphomaMedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-005450-60-GB
- Lead Sponsor
- Millennium Pharmaceuticals, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 1240
1.Male or female patients 18 years or older.
2.Treatment-naïve, HL patients with Ann Arbor Stage III or IV disease (refer to Section 15.1).
3.Patients must have histologically confirmed classical HL according to the current World Health Organisation Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted, or classical Hodgkin lymphoma, NOS [not otherwise specified]).
4.ECOG performance status = 2 (refer to Section 15.2).
5.Patients must have bidimensional measurable disease as documented by radiographic technique (spiral CT preferred) per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma (Cheson 2007).(25)
6.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, from the time of signing the informed consent through 6 months after the last dose of study drug, or
•Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)
Male patients, even if surgically sterilized (ie, status postvasectomy), 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 practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
7.Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
8.Suitable venous access for the study-required blood sampling, including PK sampling.
9.Clinical laboratory values as specified below within 7 days before the first dose of study drug:
•Absolute neutrophil count = 1,500/µL unless there is known HL marrow involvement
•Platelet count = 75,000/µL unless there is known HL marrow involvement
•Total bilirubin must be < 1.5 X the upper limit of normal (ULN) unless the elevation is known to be due to Gilbert syndrome.
•ALT or AST must be < 3 X the upper limit of the normal range. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of HL in liver.
•Serum creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute (refer to Section 15.3).
•Hemoglobin must be = 8 g/dL.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 930
F.1.3 Eld
1.Nodular lymphocyte predominant Hodgkin lymphoma
2.Female patients who are both lactating and breastfeeding or who have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug
3.Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol
4.Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML
5.Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
6.Any sensory or motor peripheral neuropathy
7.Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
8.Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy (eg, immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first study drug dose
9.Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or any component of ABVD
10.Known human immunodeficiency virus (HIV) positive
11.Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
12.Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
13.Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
•A left-ventricular ejection fraction < 50%
•Myocardial infarction within 2 years of randomization
•New York Heart Association (NYHA) Class III or IV heart failure (see Section 15.4).
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method