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Phase II study of the combination of Lenalidomide and Alemtuzumab as consolidation in patients who responded to a previus chemotherapeutic regimen administered for relapsed or refractory Chronic Lymphocytic Leukemia (CLL) - len-cam

Phase II study of the combination of Lenalidomide and Alemtuzumab as consolidation in patients who responded to a previus chemotherapeutic regimen administered for relapsed or refractory Chronic Lymphocytic Leukemia (CLL) - len-cam

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-001823-71-IT
Enrollment
Unknown
Registered
2008-05-20
Start date
2008-08-26
Completion date
Unknown
Last updated
2013-06-10

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

Conditions

CLL patients MedDRA version: 9.1 Level: LLT Classification code 10008958 Term: Chronic lymphocytic leukaemia

Interventions

Trade Name: lenalidomide Pharmaceutical Form: Tablet INN or Proposed INN: lenalidomide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15-

Sponsors

Associazione Malattie Sangue ONLUS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - signed written informed consent - age 18 years or older - WHO performance status 0-II - life expectancy > 6 months - confirmation BCLL - no major infection 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: - any serious medical condition or psychiatric illness - pregnant or lactating women - active secondary malignancy - negativity for CD52 marker - previous autologous or allogeneic stem cell transplant

Design outcomes

Primary

MeasureTime frame
Main Objective: to identify the Maximum Tolerated Dose of Lenalidomide in combination with Alemtuzumab 30mg /weekly;Secondary Objective: - efficacy and tolerability of the combination Lenalidomide and Alemtuzumab;Primary end point(s): to identify maximum tolerated dose of Lenalidomide with Alemtuzumab—

Countries

Italy

Outcome results

None listed

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