Alemtuzumab, MabCampath® with 2-weekly CHOP chemotherapy for mature T-cell non-Hodgkin's lymphoma
| ISRCTN | ISRCTN52265296 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52265296 |
| Secondary identifying numbers | HO69 |
- 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
Scientific
University Medical Center Groningen (UMCG)
Afd. Hematologie
Postbus 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 361 2354 |
|---|---|
| j.c.kluin@int.umcg.nl |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Cyclophosphamide, hydroxydaunorubicin (doxorubicin), oncovin (vincristine), prednisone/prednisolone, granulocyte colony-stimulating factor |
| Primary outcome measure | 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 study start date | 16/11/2005 |
| Completion date | 01/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
9700 RB
Netherlands
Sponsor information
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Research organisation
Research organisation
HOVON Data Center
Erasmus MC - Daniel den Hoed
P.O.Box 5201
Rotterdam
3008 AE
Netherlands
| Phone | +31 (0)10 704 1560 |
|---|---|
| hdc@erasmusmc.nl | |
| Website | http://www.hovon.nl |
"ROR" |
https://ror.org/056kpdx27 |
Funders
Funder type
Research organisation
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands) (ref: HO69)
No information available
The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands) (ref: 2005-12)
No information available
Bayer Schering Pharma (MabCampath) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
