Trial | NCT00565981  Report issue

Title

A Pilot Trial With Subcutaneous Alemtuzumab and Oral Fludarabinephosphate for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response
Subcutaneous MabCampath® (Alemtuzumab) and Oral Fludara® (Fludarabinephosphate) for the Treatment of Refractory or Relapsed Chronic Lymphocytic Leukemia in 2nd or 3rd Line of Treatment: A Pilot Trial (FLUSALEM) for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    10
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.
Study Started
Mar 31
2004
Primary Completion
Feb 13
2008
Study Completion
Feb 13
2008
Last Update
Dec 07
2017

Drug Fludarabine phosphate

orally, 40 mg/m2 d1-3 q4w, x4 cycles

  • Other names: Fludara®

Drug Alemtuzumab

subcutaneous, starting dose 3 mg and escalation to 10 mg, then 30 mg, followed by 30 mg thrice weekly for 16 weeks in escalated dose

  • Other names: MabCampath®

Overall study Experimental

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

Criteria 

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

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
No Results Posted