A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
- Conditions
- Relapsed or refractory chronic lymphocytic leukemia (CLL)MedDRA version: 14.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-002566-21-IT
- Lead Sponsor
- MEDIMMUNE ONCOLOGY INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 156
•Histologically confirmed aggressive B-cell Chromic Lymphocytic Leukemia( CLL) according to the National Cancer Institute criteria •Adequate hematological function
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26
• Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 42 days prior to treatment • Exposure to Bendamustine within 180 days before study enrollment • Any active secondary malignancy • Prior autologous or allogeneic stem cell transplantation SCT • Clinically significant abnormality on ECG • History of other invasive malignancy within 5 years except for localized/in situ, carcinomas such as cervical carcinoma in situ or basal/squamous skin cancer. • Evidence of active infection • Documented current central nervous system involvement by leukemia or lymphoma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method