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

B-cell Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565981
• Other study ID #: FLUSALEM
• 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
• 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

Related Conditions & MeSH terms

• B-cell Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

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