An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients with refractory or relapsed Non-Cutaneous CD4+ T-Cell Lymphoma - HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-000243-23-SE
• Date of registration: 08/06/2004
• Prospective Registration: Yes
• Primary sponsor: Genmab A/S
• Public title: An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients with refractory or relapsed Non-Cutaneous CD4+ T-Cell Lymphoma - HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma
• Scientific title: An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients with refractory or relapsed Non-Cutaneous CD4+ T-Cell Lymphoma - HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma
• Date of first enrolment: 03/08/2004
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000243-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1) Patients must have a diagnostic biopsy of non-cutaneous T-cell lymphoma with a CD4 positive phenotype. The biopsy must be performed within 6 months of first treatment. Patients must be diagnosed according to one of the following subgroups by histological subtypes as defined by WHO:
• Peripheral T-cell lymphoma (PTCL) unspecified
• Angioimmunnoblastic T-cell lymphoma
• Anaplastic large cell lymphoma
• Enteropathy type T-cell lymphoma
• Hepatosplenic T-cell lymphoma
2. Relapse or refractory to at least one prior chemotherapy. Refractory is defined as resistance to therapy due to lack of response or progression of disease. The relapse must be histologically confirmed. The histology should be determined through an excisional lymph node biopsy. In case this is not reasible due to different standard practice or not possible in cases of more deeply located nodes etc., a core biopsy can be performed.
3. CT scan at screening showing:
a) 2 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or
b) 1 clearly demarcated lesion of a largest diameter = 2.0 cm
c) For patients with PTCL, hepatosplenic type, liver and/or spleen must be enlarged and the case must be immunohistochemically confirmed as being CD4-positive.
d) For patients with PTCL, enteropathy type, a bioptic verification with immunohistochemically confirmed CD4-positivity must also be present.
4. Age =18
5. Following receipt of verbal and written information about the trial, the
patient must provide signed consent before any trial related activity is
carried out.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1) Prior treatment with anti-CD4 monoclonal antibodies.
2) Treatment with CdA, fludarabine or Campath® within the previous year.
3) Treatment within 4 weeks prior to visit 2 with systemic anticancer therapies, such as, but not limited to: methorexate, bleomycin, cyclophosphamide, systemic glucocorticosteroids.
4) Relapse after more than two previous lymphoma treatment regimens (high dose consolidation is not regarded as a regimen itself).
5) Leukemia.
6) Life expectancy less then 6 months.
7) WHO performance status = 3
8) Concurrent or previous malignancies within the past 5 years except adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell skin cercinoma.
9) Acute or chronic infectious disease requiring systemic medication.
10) Significant concurrent, uncontrolled or active medical condition including, but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease.
11) Screening laboratory values
i. Hemoglobin < 5.3 mmol/L (<8.7 g/dL)
ii. WBC =2.5 x 109 cells/L
iii. Neutrophils< 1.5 x 109cells/L
iv. Platelets < 75 x 109 cells/L
v. CD3+CD4+ cell count > 2000 cells/mm3
vi. ALT/AST > 4 times upper limit of normal, unless lymphoma related
vii. S-creatinine greater than 133 µmmol/L
12) Known or suspected positive serology for HIV.
13) Allogenic bone marrow transplantation.
14) Known or clinical suspicion for CNS involvement.
15) Breast-feeding women or women with a positive pregnancy test at visit 1.
16) Women of childbearing potential not using either hormonal birth control or an intrauterine device for the entire trial period.
17) Simultaneous or previous participation in a trial with any investigational drug within 4 weeks prior to start of trial treatment.
18) Patients known or suspected of being not able to comply with the requirements of the trial (e.g due to alcoholism, drug dependency or psychological disorder).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

The mature non-cutaneous T-cell lymphomas expressing the CD4 molecule are the object of this protocol. 1.Peripheral T-cell lymphoma (PTCL) unspecified 2.Angioimmunnoblastic T-cell lymphoma 3.Anaplastic large cell lymphoma 4.Enteropathy type T-cell lymphoma 5.Hepatosplenic T-cell lymphoma.
MedDRA version: 7.0 Level: LLT Classification code 10042971

Intervention(s)

Product Name: HuMax-CD4
Product Code: HuMax-CD4
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Zanolimumab
CAS Number: 652153-01-0
Current Sponsor code: HuMax-CD4
Other descriptive name: fully human monoclonal antibody against CD4 on T-cells
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20 -
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: The primary objective of this trial is to explore the efficacy of HuMax-CD4 treatment with respect to tumor response and duration in patients with refractory or relapsed non-cutaneous CD4+ T-cell lymphoma.

Primary end point(s): The primary endpoint is objective tumor response from start of treatment until week 18.

Secondary Objective: The secondary objective is to evaluate the safety of HuMax-CD4 treatment in patients with refractory or relapsed non-cutaneous CD4+ T-cell lymphoma.

Secondary ID(s)

Hx-CD4-109