Lead Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators

Age

19 - 75 years

Sex

ALL

Healthy Volunteers

No

•Male or female patients with CD23+, CD5+, CD19+, light chain monoclonal B CLL
•1st or 2nd relapse after fludarabine or any other primary treatment regimen or refractory to primary or secondary treatment (including fludarabine) and simultaneously indication for treatment according to the NCI Workshop Criteria 1996
•Age 19-75
•WHO performance score 0-2
•Informed consent given by the patient

•HIV positive or positive for Hepatitis B or C
•active uncontrolled infection
•child bearing age without adequate control of fertility, pregnant or lactating women
•intolerance towards any ingredient of either oral fludarabine or alemtuzumab
•allergy against foreign proteins
•previous treatment with alemtuzumab
•treatment with an experimental drug within the previous 2 months
•second malignant disease (non CLL)
•CLL in transformation (Richter syndrome)
•decreased kidney-function with creatinine-clearance \< 30ml/min
•severe concomitant diseases or major organ dysfunctions
•patients who are unable to comply with the requirements of the protocol

Related studies

NCT02213913 · Adult Grade III Lymphomatoid Granulomatosis, B-cell Chronic Lymphocytic Leukemia, and more

NCT03110640 · B-cell Adult Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia, and more

NCT00005799 · Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, and more

NCT00910910 · B-Cell Chronic Lymphocytic Leukemia

NCT00648739 · B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma

A Pilot Trial With Subcutaneous Alemtuzumab and Oral Fludarabinephosphate for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response