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

ISRCTN	ISRCTN52265296
DOI	https://doi.org/10.1186/ISRCTN52265296
Protocol serial number	HO69
Sponsor	Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Funders	Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands) (ref: HO69), The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands) (ref: 2005-12), Bayer Schering Pharma (MabCampath) (Netherlands)

Submission date: 18/06/2010
Registration date: 05/07/2010
Last edited: 05/07/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof J.C. Nelemans
Scientific

University Medical Center Groningen (UMCG)
Afd. Hematologie
Postbus 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 361 2354
Email	j.c.kluin@int.umcg.nl

Study information

Primary study design	Interventional
Study design	Multicentre prospective non-randomised non-blinded active controlled interventional phase II study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific 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
Study acronym	HOVON 69 T-NHL
Study objectives	Evaluation of the efficacy and toxicity of anti-CD52 (Alemtuzumab, MabCampath®) combined with 2-weekly cyclophosphamide, hydroxydaunorubicin (doxorubicin), Oncovin (vincristine), and prednisone/prednisolone (CHOP) and granulocyte colony-stimulating factor (G-CSF).
Ethics approval(s)	Medical Ethics Committee of the University Medical Center Groningen approved on the 11th August 2005 (ref: 2005.101)
Health condition(s) or problem(s) studied	Mature T-cell non-Hodgkin's lymphoma
Intervention	Patients with T-NHL meeting all eligibility criteria will be registered and treated with: 8 cycles of CHOP every 2 weeks plus G-CSF (Pegfilgrastim), combined with 24 administrations of Alemtuzumab (MabCampath ®). Patients will be evaluated for response after 3 cycles of Camp-CHOP (all patients) and after 8 cycles of Camp-CHOP (if applicable, otherwise after last cycle administered). All patients, who have not attained at least a partial response (PR) after 3 cycles of Camp-CHOP, will go off protocol treatment.
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Cyclophosphamide, hydroxydaunorubicin (doxorubicin), oncovin (vincristine), prednisone/prednisolone, granulocyte colony-stimulating factor
Primary outcome measure(s)	Complete response (CR) including complete response uncertain (CRu) on protocol
Key secondary outcome measure(s)	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 2. Overall survival measured from the time of registration 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) 4. Toxicity, Common Terminology Criteria for Adverse Events (CTCAE) grade 3 - 4, except nausea, vomiting, alopecia and haematological toxicity
Completion date	01/11/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	20
Key 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
Key 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
Date of first enrolment	16/11/2005
Date of final enrolment	01/11/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Groningen (UMCG)

Groningen
9700 RB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes