Contact information
Type
Scientific
Primary contact
Prof J.C. Nelemans
ORCID ID
Contact details
University Medical Center Groningen (UMCG)
Afd. Hematologie
Postbus 30001
Groningen
9700 RB
Netherlands
+31 (0)50 361 2354
j.c.kluin@int.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HO69
Study information
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
Acronym
HOVON 69 T-NHL
Study hypothesis
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
Medical Ethics Committee of the University Medical Center Groningen approved on the 11th August 2005 (ref: 2005.101)
Study design
Multicentre prospective non-randomised non-blinded active controlled interventional phase II study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Cyclophosphamide, hydroxydaunorubicin (doxorubicin), oncovin (vincristine), prednisone/prednisolone, granulocyte colony-stimulating factor
Primary outcome measures
Complete response (CR) including complete response uncertain (CRu) on protocol
Secondary outcome measures
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
Overall trial start date
16/11/2005
Overall trial end date
01/11/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant 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
Recruitment start date
16/11/2005
Recruitment end date
01/11/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Sponsor details
HOVON Data Center
Erasmus MC - Daniel den Hoed
P.O.Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 704 1560
hdc@erasmusmc.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands) (ref: HO69)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands) (ref: 2005-12)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bayer Schering Pharma (MabCampath) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary