Study of Brentuximab Vedotin in refractory / relapsed Hodgkin lymphoma patients who are treated by chemotherapy (ICE)

Phase 1

• Conditions: Hodgkin Lymphoma; MedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002722-13-BE
• Lead Sponsor: YSARC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-03
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Histologically confirmed CD30+ HL, primarily
refractory to first line chemotherapy or in first relapse after any
polychemotherapy regimen
2. Measurable disease defined as at least one single node or tumor
lesion on CT scan > 1.5 cm
3. FDG-PET/ CT realized at relapse and positive.
4. Age = 18 years and up to 65 years
5. ECOG Performance Status = 2
6. Life expectancy of > 3 months with treatment
7. No major organ dysfunction, unless HL-related
8. Normal cardiac and pulmonary function for auto transplantation
9. Eligible for high dose chemotherapy and autologous peripheral
blood stem cell transplantation
10. Resolution of toxicities from first-line therapy
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 55
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Peripheral sensory or motor neuropathy grade = 2
2. Any chemotherapy, radiotherapy, immunotherapy or
investigational, therapy for treatment of lymphoma within 28 days
prior C1D1
3. Patient who have been treated by first line of treatment with
brentuximab vedotin alone or in combination
4. Female patients who are both lactating and breast feeding or
have a positive serum pregnancy test during the screening period
or a positive pregnancy test prior C1D1
5. Patients with active, uncontrolled infections (requiring systemic
antibiotics within two weeks prior to treatment
6. Prior history of another cancer unless the subject has been free
of the disease for = 3 years (with the exception of non-melanoma
skin cancer, completely resected melanoma TNMpT1 or
carcinoma in situ of the uterine cervix)
7. Known cerebral or meningeal disease (HL or any other etiology),
including signs or symptoms of PML
8. Patients with known HIV seropositivity, hepatitis B, hepatitis
C (Ag detection of HBs Antigen or presence of anti HBc
antibody without detectable anti HBs antibody)
9. Patients having received radiation therapy within 8 weeks prior
C1D1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified