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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00565981
Other study ID # FLUSALEM
Secondary ID
Status Completed
Phase Phase 2
First received November 29, 2007
Last updated December 6, 2017
Start date March 2004
Est. completion date February 13, 2008

Study information

Verified date December 2017
Source Arbeitsgemeinschaft medikamentoese Tumortherapie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date February 13, 2008
Est. primary completion date February 13, 2008
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fludarabine phosphate
orally, 40 mg/m2 d1-3 q4w, x4 cycles
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

Locations

Country Name City State
Austria Landeskrankenhaus Feldkirch Feldkirch
Austria A.ö. Landeskrankenhaus Fürstenfeld Fürstenfeld
Austria Universitätsklinik Innsbruck/ Klinik für Innere Medizin Innsbruck
Austria A.ö. Landeskrankenhaus Leoben Leoben
Austria Krankenhaus der Stadt Linz Linz
Austria St. Johanns LK Salzburg
Austria A.ö. Krankenhaus der Landeshauptstadt St. Pölten St. Poelten
Austria Klinikum Kreuzschwestern Wels GmbH Wels

Sponsors (2)

Lead Sponsor Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie Schering-Plough

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability within the duration of study
Primary Complete and overall response rate within the duration of study
Primary Infections grade III, IV within the duration of study
Primary Rate of CMV reactivation within the duration of study
Secondary Time to retreatment within duration of trial
Secondary Overall survival within duration of trial
Secondary Response in lymphatic compartments within duration of trial
Secondary Molecular response/ immunologic MRD response within duration of trial
Secondary Quality of Life within duration of trial
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