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

Phase 2
Completed
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
Inclusion Criteria
  • 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
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Exclusion Criteria
  • 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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Overall studyFludarabine phosphateThe 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 studyAlemtuzumabThe 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
NameTimeMethod
Safety and tolerabilitywithin the duration of study
Complete and overall response ratewithin the duration of study
Infections grade III, IVwithin the duration of study
Rate of CMV reactivationwithin the duration of study
Secondary Outcome Measures
NameTimeMethod
Time to retreatmentwithin duration of trial
Response in lymphatic compartmentswithin duration of trial
Overall survivalwithin duration of trial
Molecular response/ immunologic MRD responsewithin duration of trial
Quality of Lifewithin 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

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