Condition category
Cancer
Date applied
18/06/2010
Date assigned
05/07/2010
Last edited
05/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hovon.nl

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

http://www.hovon.nl

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

Publication citations

Additional files

Editorial Notes