Status:
COMPLETED
Activity & Safety Study of Lenalidomide & Rituximab as Non-chemotherapy Based Therapy on Chronic Lymphocytic Leukemia
Lead Sponsor:
MD Anderson International Spain SA
Collaborating Sponsors:
Celgene Corporation
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The rationale for combining lenalidomide with rituximab derives from preclinical observations suggesting that lenalidomide may enhance the ADCC (antigen-dependent cellular cytotoxicity) triggered by m...
Eligibility Criteria
Inclusion
- Recurrent and refractory CLL patients that have received at least one previous treatment with purine analogs.
- Adequate liver function and renal function.
- ECOG performance status ≤ 2.
- Signed informed consent
- Male and female patients who are fertile agree to use an effective barrier method of birth control to avoid pregnancy.
Exclusion
- Positive serological markers for hepatitis B with the exception of HBsAc in previously vaccinated patients
- Pregnant patients
- HIV infection
- Concurrent chemotherapy or immunotherapy
- Other malignancy within the last 2 years, except for localized cutaneous carcinoma
- Neurological impairment precluding understanding of protocol and the entailed visits and procedures.
- Patients with Renal insufficiency that requires dialysis.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01185262
Start Date
April 1 2009
End Date
September 1 2013
Last Update
September 30 2013
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Reina Sofía
Córdoba, Córdoba, Spain, 14004
2
MD Anderson Internacional España
Madrid, Madrid, Spain, 28033
3
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
4
Hospital Clínico de Salamanca
Salamanca, Salamanca, Spain, 37007