Anti-CD20 treatment of relapsed or refractory immune thrombocytopaenic purpura (ITP) after first line corticosteroid treatment
| ISRCTN | ISRCTN16619820 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16619820 |
| Secondary identifying numbers | HO64 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 14/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
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
Dr H.R. Koene
Scientific
Scientific
Academic Medical Centre (AMC)
Department of Haematology
Postbus 22660
Amsterdam
1100 DE
Netherlands
| Phone | +31 (0)20 566 9111 |
|---|---|
| h.r.koene@amc.uva.nl |
Study information
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HOVON 64 ITP |
| Study objectives | The percentage of patients reaching complete response (CR), good response (GR) or moderate response (MR) in each treatment arm is greater than 50%. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Immune thrombocytopaenic purpura (ITP) |
| Intervention | All patients will be randomised between: Arm A: conventional dose rituximab 375 mg/m^2, 4 weekly doses Arm B: conventional dose rituximab 375 mg/m^2, 2 weekly + 2 weekly doses, dependent on response Arm C: high dose rituximab 750 mg/m^2, 2 weekly doses |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rituximab |
| Primary outcome measure | The response (CR/GR/MR/NR) to treatment. |
| Secondary outcome measures | 1. Need for emergency treatment (platelet count less than 10 or haemorrhagic diathesis, haemorrhage/bleeding defined by grade 3 or 4 according to NCI CTCAE v3.0) 2. Time to treatment failure/relapse |
| Overall study start date | 01/09/2005 |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | 1. Age minimal 18 years 2. Subjects with relapsed or refractory ITP (fulfilling the diagnostic criteria given in appendix A) and platelet numbers less than 30 x 10^9/l 3. Having completed first line treatment with corticosteroids 4. Written informed consent 5. World Health Organization (WHO) performance status less than or equal to 2 |
| Key exclusion criteria | 1. The presence of an accessory spleen in splenectomized patients 2. Use of anticoagulants or chemotherapy or known other disorders and/or treatments influencing the platelet number within 3 months of randomisation date (tranexaminic acid [Cyklokapron®] treatment is allowed) 3. Pulsed or high dose corticosteroids, IVIG or splenectomy within 3 weeks prior to randomisation. Maintenance corticosteroid therapy is allowed. 4. Prior therapy with rituximab 5. ITP treatments (other than corticosteroids, IVIG or splenectomy) within 3 months prior to randomisation (e.g. cyclosporin, vincristine). Stable treatment with non-immunosuppressive medication (i.e. danazol, dapson, vitamin C) is permitted. 6. Inadequate renal and liver function, i.e. creatinine or bilirubin greater than 25 x the upper normal value 7. Neutrophil count less than 15 x 10^9/l and haemoglobin level less than 62 mmol/l 8. Active bleeding (defined by grade 3 or 4 according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v3.0) 9. Pregnant or lactating 10. Systemic infections: active viral infections, including human immunodeficiency virus (HIV) 11. Seriously immunocompromised patients 12. Systemic autoimmune disorders (e.g. systemic lupus erythematosus [SLE]) 13. Current malignant disease 14. Any experimental therapy within 30 days prior to randomisation |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/05/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DE
Netherlands
1100 DE
Netherlands
Sponsor information
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands) - Data Centre
Research organisation
Research organisation
Erasmus Medical Centre
Daniel den Hoed Kliniek
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
| Phone | +31 (0)10 439 1568 |
|---|---|
| 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) (The 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 |
