A multicenter randomized study on the use of rabbit anti-T-Lymphocite globulin ATG different doses to prevent GVHD in children receiving allogenic stem cell transplantation - ND

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004067-53-IT

Enrollment

200

Registered

2007-08-14

Start date

2006-09-05

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ematological malignant neoplasm MedDRA version: 6.1 Level: PT Classification code 10018651

Interventions

Trade Name: THYMOGLOBULINE*1F 25MG+1F 5ML Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Antithymocyte immunoglobulin rabbit Concentration unit: mg milligra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: male or female 0-18 years old; patient with one of the following condition LLL in 1 , 2 or 3 complete remission; LMA in 1 , 2 or 3 complete remission; LNH in 2 or 3 complete remission; LMC Ph in 1 or 2 chronic phase or accelerate phase; ... Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: prior allogenic stem cell transplantation; hypersensitivity to thymoglobuline, ...

Design outcomes

Primary

Measure	Time frame
Main Objective: to evaluate the effect of different doses of ATG in patients undergoing stem cell transplantation;Secondary Objective: One of these is to evaluate acute GVHD occurence in each of the 4 groups of patients;Primary end point(s): disease rejection	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026