Randomized study to evaluate the efficacy of therapy with BrentuximabVedotin-Etoposide, Methylprednisolone, Cisplatin and Cytarabine (ESHAP)vs ESHAP in patients with Hodgkin's Lymphoma, followed by treatmentwith Brentuximab Vedotin in patients who reach metabolic response aftersalvage therapy
- Conditions
- Patients with Relapsed /Refractory Classical Hodgkin's LymphomaMedDRA version: 20.1Level: LLTClassification code 10080208Term: Classical Hodgkin lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2019-002746-21-GR
- Lead Sponsor
- Grupo Español de linfomas y trasplante autologo de medula osea (GELTAMO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
Patients with classical HL CD30+ confirmed histologically (either at the time of diagnosis / at the time of first relapse) will be included in the trial. A biopsy at the time of relapse / demonstration of primary refractoriness is highly recommended. Patients diagnosed with 1st relapsed/refractory HL (treatment escalation or de-escalation, performed according to interim PET-CT result in first-line therapy, will still be considered as a single prior line, i.e., RATHL or LYSARC trials) will also be considered candidates for the trial. Each patient must meet all of the following inclusion criteria to be enrolled in the study:
1.Male or female patients 18 years or older up to 65 years of age
2.Voluntary written informed 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
3.Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 highly 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 agrees to completely abstain from heterosexual intercourse
4. Male patients, even if surgically sterilized, (i.e., status post-vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse
5.ECOG performance status 0 to 2
6.Measurable disease at time of enrolment (lymphadenopathy/ extranodal mass of at least 1.5 cm)
7.No evidence of neuropathy grade =2
8.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 hematologic/solid tumor marrow involvement
•Platelet count = 75,000/ µL unless there is known marrow involvement of the disease
•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.
•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 hematologic/solid tumor in liver
•Serum creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute
•Hemoglobin must be = 8g/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 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Lymphocyte predominant nodular Hodgkin’s lymphoma
2.Prior treatment with brentuximab vedotin
3.Female patient who is both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug
4.Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to the protocol.
5.Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
6. Symptomatic neurologic disease compromising normal activities of daily living or requiring medic
7. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
8.Known history of any of the following cardiovascular conditions
•Myocardial infarction within 2 years of enrollment
•New York Heart Association (NYHA) Class III or IV heart failure (see Appendix #9)65
•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%
9. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
10.Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives (or 28 days if the half-lives are unknown) of last dose of that prior treatment
11.Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
12.Known human immunodeficiency virus (HIV) positive positive (in case of Anti-HIV positive result patient cannot be included in the study
13.Known hepatitis B surface or core antigen-positive (HBsAg/ HBcAg). In case of Anti HBc positive result, DNA-HBV must be determined and negative result will allow patient inclusion. known or suspected active hepatitis C infection. In case of Anti-HCV positive result, RNA-HCV must be determined and negative result will allow patient inclusion
14.Focal radiation therapy within 30 days prior to study recruitment
15.Major surgery within 28 days prior to randomization
16.Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have 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.
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