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Spontaneous monocentric study phase II: salvage therapy with clofarabine in combination with other cytotoxic agentsfor the treatment of resistent leukemia in children - ND

Spontaneous monocentric study phase II: salvage therapy with clofarabine in combination with other cytotoxic agentsfor the treatment of resistent leukemia in children - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-004487-39-IT
Enrollment
Unknown
Registered
2009-03-19
Start date
2008-11-25
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

Acute Leukemia MedDRA version: 9.1 Level: LLT Classification code 10000830 Term: Acute leukaemia

Interventions

Trade Name: EVOLTRA Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Clofarabine Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 20-

Sponsors

ISTITUTO GIANNINA GASLINI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients with resistent leukemia to primary therapy 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: Age > 18 years

Design outcomes

Primary

MeasureTime frame
Main Objective: Efficacy of clofarabine in combination to reach RC;Secondary Objective: 1.Tolerability and persitence of RC to perform bone marrow transplantation;Primary end point(s): Efficacy of clofarabine in combination to reach RC—

Countries

Italy

Outcome results

None listed

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