R788 as treatment for residual disease after chemotherapy in patients with chronic lymphocytic leukemia - ND
- Conditions
- Chronic Lymphocytic leukemiaMedDRA version: 9.1Level: LLTClassification code 10008956Term: Chronic lymphatic leukaemia
- Registration Number
- EUCTR2009-009034-32-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
B-CLL (NCI Working group criteria) and:  Disease response to previous induction chemo-immunotherapy (PR or CR with MRD) after almost 2 months from the end of induction therapy;  Age≥50 years;  Written informed consensus Approved by Ethical committee, dated and signed;  Performance status, (World Health Organization criteria) ≤ to2;  Life expectance >6 months
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) yes
F.1.3.1 Number of subjects for this age range
 Stable or progressive disease after chemo-immunotherapy;  Complete Remission with absence of MRD;  Delivery or breast feeding;  Age ≤ 50 years;  Active secondary malignancies  Active infection disease  Patients unwilling or unable to comply with the protocol for medical, familiar, geographic, psycho-social problem.
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