Condition category
Haematological Disorders
Date applied
11/03/2010
Date assigned
07/04/2010
Last edited
07/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alexei Maschan

ORCID ID

Contact details

Leninskii prt 117
Moscow
117997
Russian Federation
+7 495 936 91 69
amaschan@mail.ru

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12

Study information

Scientific title

Direct randomised comparison of horse anti-thymocyte globulin and rabbit anti-thymocyte globulin in children with severe aplastic anaemia

Acronym

Study hypothesis

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

Local Ethics Committee of Research Institute of Pediatric Hematology approved on the 11th December 2000 (ref: 1-12-1999)

Study design

Randomised two-period cross-over study

Primary study design

Interventional

Secondary study design

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

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

Phase

Phase IV

Drug names

Rabbit anti-thymocyte globulin (ATG), horse ATG

Primary outcome measures

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 trial start date

01/12/2000

Overall trial end date

01/02/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged from 1 - 18 years, either sex
2. Diagnosis of severe aquiered aplastic anaemia

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/12/2000

Recruitment end date

01/02/2003

Locations

Countries of recruitment

Russian Federation

Trial participating centre

Leninskii prt 117
Moscow
117997
Russian Federation

Sponsor information

Organisation

Federal Clinical Research Center of Pediatric Hematology, Oncology and Immunology (Russia)

Sponsor details

Leninskii prt 117
Moscow
117997
Russian Federation
+7495 936 91 59
info@niidg.ru

Sponsor type

Research organisation

Website

http://www.niidg.ru

Funders

Funder type

Research organisation

Funder name

Federal Clinical Research Center of Pediatric Hematology, Oncology and Immunology (Russia)

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