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

NCT ID: NCT00565981

Last Updated: 2017-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2008-02-13

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.

Conditions

B-cell Chronic Lymphocytic Leukemia

Keywords

B-CLL; refractory; molecular profiling; alemtuzumab; fludarabinephosphate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Overall study

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

Group Type: EXPERIMENTAL

Fludarabine phosphate

Intervention Type: DRUG

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

Alemtuzumab

Intervention Type: DRUG

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

Interventions

Fludarabine phosphate

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Fludara®; MabCampath®

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Greil, MD

Role: PRINCIPAL_INVESTIGATOR

IIIrd Medical Department for Hematology, Oncology, Rheumatology, Infectiology and Hemostasiology at the Medical University of Salzburg

Locations

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

Sankt Pölten, , Austria

Klinikum Kreuzschwestern Wels GmbH

Wels, , Austria

Countries

Austria

Other Identifiers

FLUSALEM

Identifier Type: -

Identifier Source: org_study_id