A Pilot Trial With Subcutaneous Alemtuzumab and Oral Fludarabinephosphate for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response
- Conditions
- B-cell Chronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT00565981
- Lead Sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Brief Summary
Open label multicenter, two-step, non-randomized (pilot) study to analyze the safety of 4 cycles of 3-day 40mg/m2 oral fludarabine with simultaneous thrice weekly application of 30mg alemtuzumab s.c. in patients with B-CLL disease in 1st and 2nd relapse after any primary treatment or with disease refractory to any therapy in 1st or 2nd line (including Fludarabine, ). This regimen is preceded by an escalation phase with 3-10-30 mg of alemtuzumab s.c.
After the first phase (completed treatment of 7 patients) an interim analysis of safety and efficacy will be performed. In case of a sufficient risk benefit assessment followed by the enrollment of further 21 patients. Final analysis of safety and preliminary efficacy will be based on all patients enrolled.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Overall study Fludarabine phosphate The FLUSALEM protocol combines 4 cycles of oral fludarabine phosphate (40mg/m² d1-3; q 29d) and an intensive dose schedule of alemtuzumab (30mg sc.3 times weekly for 16 weeks) in an outpatient setting Overall study Alemtuzumab The FLUSALEM protocol combines 4 cycles of oral fludarabine phosphate (40mg/m² d1-3; q 29d) and an intensive dose schedule of alemtuzumab (30mg sc.3 times weekly for 16 weeks) in an outpatient setting
- Primary Outcome Measures
Name Time Method Safety and tolerability within the duration of study Complete and overall response rate within the duration of study Infections grade III, IV within the duration of study Rate of CMV reactivation within the duration of study
- Secondary Outcome Measures
Name Time Method Time to retreatment within duration of trial Response in lymphatic compartments within duration of trial Overall survival within duration of trial Molecular response/ immunologic MRD response within duration of trial Quality of Life within duration of trial
Trial Locations
- Locations (8)
Universitätsklinik Innsbruck/ Klinik für Innere Medizin
🇦🇹Innsbruck, Austria
A.ö. Landeskrankenhaus Fürstenfeld
🇦🇹Fürstenfeld, Austria
St. Johanns LK
🇦🇹Salzburg, Austria
A.ö. Krankenhaus der Landeshauptstadt St. Pölten
🇦🇹St. Poelten, Austria
Landeskrankenhaus Feldkirch
🇦🇹Feldkirch, Austria
Krankenhaus der Stadt Linz
🇦🇹Linz, Austria
A.ö. Landeskrankenhaus Leoben
🇦🇹Leoben, Austria
Klinikum Kreuzschwestern Wels GmbH
🇦🇹Wels, Austria