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11 February 2012
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| [ Print-friendly version ] |
| Alemtuzumab, MabCampath® with 2-weekly CHOP chemotherapy for mature T-cell non-Hodgkin's lymphoma |
| ISRCTN | ISRCTN52265296 |
| ClinicalTrials.gov identifier | |
| Public title | Alemtuzumab, MabCampath® with 2-weekly CHOP chemotherapy for mature T-cell non-Hodgkin's lymphoma |
| 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 |
| Serial number at source | HO69 |
| 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). |
| Lay summary | |
| 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 |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Mature T-cell non-Hodgkin's lymphoma |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 16/11/2005 |
| Anticipated end date | 01/11/2007 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 20 |
| Interventions |
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. |
| Primary outcome measure(s) | Complete response (CR) including complete response uncertain (CRu) on protocol |
| 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 |
| Sources of funding |
1. Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands) (ref: HO69)
2. The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands) (ref: 2005-12) 3. Bayer Schering Pharma (MabCampath) (Netherlands) |
| Trial website | http://www.hovon.nl |
| Publications | |
| Contact name | Prof J.C. Nelemans |
| Address |
University Medical Center Groningen (UMCG)
Afd. Hematologie Postbus 30001 |
| City/town | Groningen |
| Zip/Postcode | 9700 RB |
| Country | Netherlands |
| Tel | +31 (0)50 361 2354 |
| Fax | +31 (0)50 361 4862 |
| j.c.kluin@int.umcg.nl | |
| Sponsor | Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands) |
| Address |
HOVON Data Center
Erasmus MC - Daniel den Hoed P.O.Box 5201 |
| City/town | Rotterdam |
| Zip/Postcode | 3008 AE |
| Country | Netherlands |
| Tel | +31 (0)10 704 1560 |
| Fax | +31 (0)10 704 1028 |
| hdc@erasmusmc.nl | |
| Sponsor website: | http://www.hovon.nl |
| Date applied | 18/06/2010 |
| Last edited | 05/07/2010 |
| Date ISRCTN assigned | 05/07/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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