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

Phase 1

Conditions: CD4 positive non-cutaneous peripheral T-Cell Lymphoma with nodal involvement
MedDRA version: 8.1Level: LLTClassification code 10034624Term: Peripheral T-cell lymphoma unspecified NOS

Registration Number: EUCTR2006-004516-51-NL

Lead Sponsor: Genmab A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

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.

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

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