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Thiotepa dose finding study for allogeneic SCT in adult patients with high risk haematological malignancies - ND

Thiotepa dose finding study for allogeneic SCT in adult patients with high risk haematological malignancies - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-007593-31-IT
Enrollment
Unknown
Registered
2009-03-23
Start date
2008-11-21
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

bone marrow transplantation

Interventions

Trade Name: THIOPLEX Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Thiotepa Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15-

Sponsors

FONDAZIONE RICERCA TRAPIANTO DI MIDOLLO OSSEO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: age > 18 high risk hematological disease Karnofsky Index >70 HLA identical sibling donor Comorbidity index score (Sorror =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Contrindication for high dose chemotherapy neurophaty no pregnancy virus HIV positive

Design outcomes

Primary

MeasureTime frame
Main Objective: feasibility and toxicity of high dose of thiotepa;Secondary Objective: Efficacy Mortality Progression disease;Primary end point(s): grade toxicity >=4 Transplat mortality related—

Countries

Italy

Outcome results

None listed

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