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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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8 August 2022 |
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Main ID: |
EUCTR2006-004516-51-NL |
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Date of registration:
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20/10/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A multicentre open-label, dose-escalation, trial of zanolimumab in combination with CHOP chemotherapy in subjects with CD4 positive non-cutaneous peripheral T-Cell Lymphoma with nodal involvement - Zanolimumab with CHOP in CD4+ non-cutaneous PTCL with nodal involvement
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Scientific title:
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A multicentre open-label, dose-escalation, trial of zanolimumab in combination with CHOP chemotherapy in subjects with CD4 positive non-cutaneous peripheral T-Cell Lymphoma with nodal involvement - Zanolimumab with CHOP in CD4+ non-cutaneous PTCL with nodal involvement |
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Date of first enrolment:
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20/11/2006 |
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Target sample size:
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24 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004516-51 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Dose escalation
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Germany
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Italy
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Netherlands
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Non-cutaneous peripheral T-cell lymphoma, with nodal involvement, with a CD4
positive phenotype confirmed by biopsy that must be performed within 2 months of
Screening (node involvement must be accessible and measurable) excluding ALK+
ALCL.
2. Subjects must be eligible for the CHOP chemotherapy regimen.
3. Subjects may have had no more than one previous chemotherapy, excluding
anthracyclines, and must have been in remission for at least one year.
4. Measurable disease according to the Standardized Response Criteria for NHL
5. Age = 18 years.
6. Has read and understands and has signed the informed consent (or has a legally
acceptable representative who has signed on their behalf).
7. Women of childbearing potential (i.e all female patients after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive) must have a negative pregancy test at screening.
8. Women of childbearing potential and males with female partners of childbearing potential must be willing to avoid pregancy by using an adequate method of contraception (defined as two barrier methods, or one barrier method with a spermicide, or intrauterine device or use of the oral female contraceptive) for 4 weeks prior to and during the study and 8 weeks after the end of the last 3 week cycle of CHOP).
9. ECOG performance status = 2
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. Known or suspected hypersensitivity to CHOP or components of the IMP.
2. Known infection with HIV, unresolved hepatitis C (HCV RNA+ in plasma) or
hepatitis B (HBV DNA+, HBs Ag+, HBc Ag+), signs and symptoms of transmissible
spongiform encepalopathy.
3. Other concurrent or previous malignancies within the past 5 years, except adequately treated in situ carcinoma of the uterine cervix or basal cell carcinoma.
4. Significant concurrent, uncontrolled or active medical condition including, but not
limited to acute or chronic infectious disease requiring systemic medication, renal,
hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological,
cerebral or psychiatric disease.
5. Known or clinical suspicion for CNS involvement of the PTCL with nodal
involvement.
6. Severe bone marrow impairment as evidenced by Hemoglobin (Hb) < 9.0 g/dL ,
absolute neutrophil count (ANC) < 0.5x 109/l, platelets < 20 x 109/l at Screening.
7. Subjects having received extensive radiotherapy (involving = 30% of bone marrow)
within the last 2 years.
8. Renal impairment as evidenced by serum creatinine > 1.5 x upper limit of normal
(ULN), and/or calculated creatinine clearance < 60 ml/min at Screening.
9. Liver function abnormality as defined by total bilirubin > 1.5 ULN and/or AST/ALT >
2.5x ULN or for subjects with liver involvement AST/ALT > 5x ULN.
10. INR > 1.5 x ULN at Screening.
11. Breast-feeding women or women with a positive pregnancy test at Screening
12. Any immunosuppressive or cytotoxic drugs within 3 months from Screening (e.g.
drugs interfering with the functions of T cells, IL-2, etc.)
13. Prior treatment with anti-CD4 monoclonal antibodies within one year prior to
Screening.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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CD4 positive non-cutaneous peripheral T-Cell Lymphoma with nodal involvement
MedDRA version: 8.1
Level: LLT
Classification code 10034624
Term: Peripheral T-cell lymphoma unspecified NOS
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Intervention(s)
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Product Name: zanolimumab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: zanolimumab
CAS Number: 652153-01-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Product Name: cyclophosphamide
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: cyclophosphamide
CAS Number: 50-18-0
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 750-
Product Name: doxorubicine
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: doxorubicine
CAS Number: 23214-92-8
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 50-
Product Name: vincristine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: vincristine
CAS Number: 57-22-7
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 1.5-
Product Name: prednisone
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisone
CAS Number: 53-03-2
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 100-
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Primary Outcome(s)
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Secondary Objective: 1. Assess the pharmacokinetic (PK) profile of zanolimumab and doxorubicin when
zanolimumab is administered concomitantly with CHOP
2. Assess pharmacodynamic (Pd) parameters in order to look for associations with
PK, tolerability and efficacy signals. Tumor metabolic activity will be measured in
a subset of subjects (centers with PET scanners).
3. Investigate efficacy signals (CR, CRu, PR)
4. Investigate host immune response to zanolimumab administration
5. To explore changes in CD4 positivity in subjects with biopsy for progressive
disease.
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Primary end point(s): The number of subjects experiencing a Dose-Limiting Toxicity (DLT) related to study drug during the first Cycle of CHOP in each cohort.
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Main Objective: To investigate safety and tolerability of ascending doses of zanolimumab up to 20mg/kg in combination with CHOP chemotherapy in order to define a maximum tolerated dose (MTD) in subjects with CD4 positive non-cutaneous peripheral T-Cell Lymphoma with nodal involvement.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 20/11/2006
Contact:
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