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A phase II, multicentre, clinical study evaluating the safety and efficacy of Treosulfan-based conditioning of allogenic transplantation of haemopoietic stem-cells in patients affected by Thalassemia Major - ND

A phase II, multicentre, clinical study evaluating the safety and efficacy of Treosulfan-based conditioning of allogenic transplantation of haemopoietic stem-cells in patients affected by Thalassemia Major - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005913-40-IT
Enrollment
10
Registered
2006-03-15
Start date
2006-01-17
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

Thalassemia Major MedDRA version: 6.1 Level: SOC Classification code 10005329

Interventions

Trade Name: Treosulfan Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Treosulfan Concentration unit: g gram(s) Concentration type: equal Concentration number: 1-

Sponsors

OSPEDALE POLICLINICO S. MATTEO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - patients affected by Thalassemia Major - age 1-30 years old, etc... 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: - not provided written voluntary informed consent by parents -hepatic desease, etc...

Design outcomes

Primary

MeasureTime frame
Secondary Objective: to evaluate overall survival OS , etc...;Primary end point(s): to evaluate rapid engraftment, etc...;Main Objective: to evaluate the safety and efficacy of Treosulfan-based conditioning of allogenic transplantation of haemopoietic stem-cells in patients affected by Thalassemia Major—

Countries

Italy

Outcome results

None listed

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