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A PILOT STUDY OF SEQUENTIAL, NON-MYELOABLATIVE HLA-IDENTICAL SIBLING DONOR ALLOGENEIC STEM CELL TRANSPLANTATION FOLLOWED BY IV TEMSIROLIMUS IN PATIENTS WITH ADVANCED, TKI-REFRACTORY CLEAR-CELL RENAL CELL CANCER - ND

A PILOT STUDY OF SEQUENTIAL, NON-MYELOABLATIVE HLA-IDENTICAL SIBLING DONOR ALLOGENEIC STEM CELL TRANSPLANTATION FOLLOWED BY IV TEMSIROLIMUS IN PATIENTS WITH ADVANCED, TKI-REFRACTORY CLEAR-CELL RENAL CELL CANCER - ND

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-003870-16-IT
Enrollment
31
Registered
2008-06-12
Start date
2008-09-22
Completion date
Unknown
Last updated
2021-10-26

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

Conditions

PATIENTS WITH ADVANCED, TKI-REFRACTORY CLEAR-CELL RENAL CELL CANCER MedDRA version: 9.1 Level: LLT Classification code 10050513 Term: Metastatic renal cell carcinoma

Interventions

Product Name: torisel Product Code: torisel Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: TEMSIROLIMUS Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Co

Sponsors

OSPEDALE S. RAFFAELE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age >18 and 6 months. Availability of an HLA-identical family donor Written informed consent to participate in this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: Active brain metastasis. Rapidly progressing disease, as defined by LDH 2x UNL or PD in two months before allografting. Pregnant, or lactating, or unable to practice effective imitino tion. Abnormal end organ function: cardiac, liver, lung. Abnormal renal function, as defined by serum creatinine 1.5x normal limit Prior treatment with temsirolimus

Design outcomes

Primary

MeasureTime frame
Main Objective: to assess the antitumor effects of the combination of allografting and mTOR inhibition in patients with TKI-refractory clear cell RCC.;Secondary Objective: to assess the feasibility and the tolerability of a new conditioning regimen for allografting in renal cell cancer, and to define the long-term antitumor effects of the combined treatment with temsirolimus.;Primary end point(s): Progression-free survival at 6 months after transplantation—

Countries

Italy

Outcome results

None listed

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