Main info

Identifier:

HOVON 69 T-NHL

Sponsor:

HOVON

Included patients:

20

Active sites:

19

(of 19)

Title:

A phase II study of anti-CD52 monoclonal antibody (Alemtuzumab, MabCampath) with 2-weekly CHOP chemotherapy (Camp-CHOP 14) in patients with mature T-cell non-Hodgkin's lymphoma.

Timeline

Flow

Details

Phase:

Prospective Phase II study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Patients with a confirmed histologic diagnosis of T-NHL according to the WHO classification:

a. Extranodal NK/T cell lymphoma, nasal type;
b. Enteropathy-type T-cell lymphoma (EATL), if measurable disease;
c. Subcutaneous panniculitis-like T-NHL;
d. Angioimmunoblastic T-cell lymphoma;
e. Peripheral T-cell lymphoma, unspecified (T-NHL NOS);

• Age 18-65 years inclusive;
• Ann Arbor stage II or more;
• WHO performance status 0, 1 or 2;
• Measurable disease;
• Written informed consent

Exclusion Criteria:

• Patients with NK/T-NHL of the following type:

a. Precursor T cell lymphoblastic lymphoma/leukemia;
b. All mature T cell leukemias (T-PLL, ATLL, NK cell leukemia, T-LGL);
c. Anaplastic large cell lymphoma;
d. Hepatosplenic T cell lymphoma;
e. Enteropathy-type T cell lymphoma without measurable disease;
f. Blastic NK cell lymphoma;

• Intolerance of exogenous protein administration;
• Severe cardiac dysfunction (NYHA classification II-IV) or LVEF < 45 %;
• Significant renal dysfunction (serum creatinine >= 150 mmol/l), unless related to NHL;
• Significant hepatic dysfunction (total bilirubin >= 30 mmol/l or transaminases >= 2.5 times normal level), unless related to NHL;
• Suspected or documented Central Nervous System involvement by NHL;
• Patients known to be HIV-positive;
• Patients with active, uncontrolled infections;
• Patients with uncontrolled asthma or allergy, requiring steroid treatment;
• Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of (potential) organ dysfunction by localized lymphoma mass or infiltration;
• History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma;

Participating Sites

= Active hospitals

= Inactive hospitals