Alemtuzumab, MabCampath® with 2-weekly CHOP chemotherapy for mature T-cell non-Hodgkin's lymphoma

Completed

• Conditions: Mature T-cell non-Hodgkin's lymphoma; Cancer; Other and unspecified types of non-Hodgkin's lymphoma

• Registration Number: ISRCTN52265296
• Lead Sponsor: Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients with a confirmed histologic diagnosis of T-cell non-Hodgkin's lymphoma (T-NHL) according to the World Health Organization (WHO) classification:
1.1. Extranodal NK/T cell lymphoma, nasal type
1.2. Enteropathy-type T-cell lymphoma (EATL), if measurable disease
1.3. Subcutaneous panniculitis-like T-NHL
1.4. Angioimmunoblastic T-cell lymphoma
1.5. Peripheral T-cell lymphoma, unspecified (T-NHL NOS)
2. Aged 18 - 65 years inclusive, either sex
3. Stage II or more
4. WHO performance status 0, 1 or 2
5. Measurable disease
6. Written informed consent

Exclusion Criteria

1. Patients with NK/T-NHL of the following type:
1.1. Precursor T cell lymphoblastic lymphoma/leukaemia
1.2. All mature T cell leukaemias (T-PLL, ATLL, NK cell leukaemia, T-LGL)
1.3. Anaplastic large cell lymphoma
1.4. Hepatosplenic T cell lymphoma
1.5. Enteropathy-type T cell lymphoma without measurable disease
1.6. Blastic NK cell lymphoma
2. Intolerance of exogenous protein administration
3. Severe cardiac dysfunction (New York Heart Association [NYHA] classification II - IV, appendix F) or left ventricular ejection fraction (LVEF) less than 45%
4. Significant renal dysfunction (serum creatinine greater than or equal to 150 µmol/l), unless related to NHL
5. Significant hepatic dysfunction (total bilirubin greater than or equal to 30 µmol/l or transaminases greater than or equal to 2.5 times normal level), unless related to NHL
6. Suspected or documented central nervous system involvement by NHL
7. Patients known to be human immunodeficiency virus (HIV)-positive
8. Patients with active, uncontrolled infections
9. Patients with uncontrolled asthma or allergy, requiring steroid treatment
10. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of (potential) organ dysfunction by localised lymphoma mass or infiltration
11. History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete response (CR) including complete response uncertain (CRu) on protocol

Secondary Outcome Measures

Name	Time	Method
1. Event-free survival, i.e., time from registration to induction failure (no CR, CRu or PR on induction treatment), death or relapse whichever occurs first; the time to failure of patients with induction failure is set at one day<br>2. Overall survival measured from the time of registration<br>3. Disease-free interval (duration of the first CR/CRu) measured from the time of achievement of CR to day of relapse or death from any cause (whichever occurs first)<br>4. Toxicity, Common Terminology Criteria for Adverse Events (CTCAE) grade 3 - 4, except nausea, vomiting, alopecia and haematological toxicity