Comparison of anti-thymocyte globulin preparations in severe aplastic anaemia
| ISRCTN | ISRCTN70251363 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70251363 |
| Secondary identifying numbers | 12 |
- Submission date
- 11/03/2010
- Registration date
- 07/04/2010
- Last edited
- 07/04/2010
- 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
Prof Alexei Maschan
Scientific
Scientific
Leninskii prt 117
Moscow
117997
Russian Federation
| Phone | +7 495 936 91 69 |
|---|---|
| amaschan@mail.ru |
Study information
| Study design | Randomised two-period cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | 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 | Direct randomised comparison of horse anti-thymocyte globulin and rabbit anti-thymocyte globulin in children with severe aplastic anaemia |
| Study objectives | Rabbit anti-thymocyte globulin (ATG) has equivalent activity compared to standard horse ATG as part of combined immune suppression in children with severe aplastic anaemia. |
| Ethics approval(s) | Local Ethics Committee of Research Institute of Pediatric Hematology approved on the 11th December 2000 (ref: 1-12-1999) |
| Health condition(s) or problem(s) studied | Severe aplastic anaemia |
| Intervention | Combined immunosupressive therapy with cyclosporin A and either horse ATG (ATGAM, Apjohn) - standard arm or rabbit ATG (ATG-Fresenius, Fresenius) - study arm. Horse ATG (ATGAM) was used in a standard 160 mg\kg total dose, given as four consequtive daily 40 mg\kg doses as long I.V. infusion. Rabbit ATG (ATG-Fresenius) was given 40 mg\kg total dose, given as four consequtive daily 10 mg\kg doses as long I.V. infusion. Cyclosporine A was given per os in a 5 mg\kg\day for at least 18 months total duration. Total duration of follow up is 7 years. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Rabbit anti-thymocyte globulin (ATG), horse ATG |
| Primary outcome measure | 1. Minimal haematologic response rate at day 180 from therapy start 2. Complete haematologic response rate, assessed at last follow-up (5 years from time of enrolment of the last patient) 3. Overall survival, assessed at last follow-up (5 years from time of enrolment of the last patient) |
| Secondary outcome measures | 1. Relapse probability in patients who achieved haematologic response, assessed at last follow-up (5 years from time of enrolment of the last patient) 2. Event-free survival, assessed at last follow-up (5 years from time of enrolment of the last patient) 3. Toxicity, assessed at day 30 from therapy start |
| Overall study start date | 01/12/2000 |
| Completion date | 01/02/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Aged from 1 - 18 years, either sex 2. Diagnosis of severe aquiered aplastic anaemia |
| Key exclusion criteria | 1. Previous immune supressive therapy with ATG and/or cyclosporin A 2. Previous corticosteroid therapy over 2 weeks 3. Inherited bone marrow failure syndrome 4. Uncontrolled invasive fungal infection |
| Date of first enrolment | 01/12/2000 |
| Date of final enrolment | 01/02/2003 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
Leninskii prt 117
Moscow
117997
Russian Federation
117997
Russian Federation
Sponsor information
Federal Clinical Research Center of Pediatric Hematology, Oncology and Immunology (Russia)
Research organisation
Research organisation
Leninskii prt 117
Moscow
117997
Russian Federation
| Phone | +7495 936 91 59 |
|---|---|
| info@niidg.ru | |
| Website | http://www.niidg.ru |
"ROR" |
https://ror.org/02h8dsx08 |
Funders
Funder type
Research organisation
Federal Clinical Research Center of Pediatric Hematology, Oncology and Immunology (Russia)
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 |
