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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

Primary Purpose

B-cell Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Fludarabine phosphate
Alemtuzumab
Sponsored by
Arbeitsgemeinschaft medikamentoese Tumortherapie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Chronic Lymphocytic Leukemia focused on measuring B-CLL, refractory, molecular profiling, alemtuzumab, fludarabinephosphate

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Landeskrankenhaus Feldkirch
  • A.ö. Landeskrankenhaus Fürstenfeld
  • Universitätsklinik Innsbruck/ Klinik für Innere Medizin
  • A.ö. Landeskrankenhaus Leoben
  • Krankenhaus der Stadt Linz
  • St. Johanns LK
  • A.ö. Krankenhaus der Landeshauptstadt St. Pölten
  • Klinikum Kreuzschwestern Wels GmbH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Overall study

Arm Description

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

Outcomes

Primary Outcome Measures

Safety and tolerability
Complete and overall response rate
Infections grade III, IV
Rate of CMV reactivation

Secondary Outcome Measures

Time to retreatment
Overall survival
Response in lymphatic compartments
Molecular response/ immunologic MRD response
Quality of Life

Full Information

First Posted
November 29, 2007
Last Updated
December 6, 2017
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00565981
Brief Title
A Pilot Trial With Subcutaneous Alemtuzumab and Oral Fludarabinephosphate for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
February 13, 2008 (Actual)
Study Completion Date
February 13, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Schering-Plough

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Chronic Lymphocytic Leukemia
Keywords
B-CLL, refractory, molecular profiling, alemtuzumab, fludarabinephosphate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Overall study
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fludarabine phosphate
Other Intervention Name(s)
Fludara®
Intervention Description
orally, 40 mg/m2 d1-3 q4w, x4 cycles
Intervention Type
Drug
Intervention Name(s)
Alemtuzumab
Other Intervention Name(s)
MabCampath®
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
within the duration of study
Title
Complete and overall response rate
Time Frame
within the duration of study
Title
Infections grade III, IV
Time Frame
within the duration of study
Title
Rate of CMV reactivation
Time Frame
within the duration of study
Secondary Outcome Measure Information:
Title
Time to retreatment
Time Frame
within duration of trial
Title
Overall survival
Time Frame
within duration of trial
Title
Response in lymphatic compartments
Time Frame
within duration of trial
Title
Molecular response/ immunologic MRD response
Time Frame
within duration of trial
Title
Quality of Life
Time Frame
within duration of trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Greil, MD
Organizational Affiliation
IIIrd Medical Department for Hematology, Oncology, Rheumatology, Infectiology and Hemostasiology at the Medical University of Salzburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landeskrankenhaus Feldkirch
City
Feldkirch
ZIP/Postal Code
A-6806
Country
Austria
Facility Name
A.ö. Landeskrankenhaus Fürstenfeld
City
Fürstenfeld
ZIP/Postal Code
A-8280
Country
Austria
Facility Name
Universitätsklinik Innsbruck/ Klinik für Innere Medizin
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
A.ö. Landeskrankenhaus Leoben
City
Leoben
ZIP/Postal Code
A-8700
Country
Austria
Facility Name
Krankenhaus der Stadt Linz
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
St. Johanns LK
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
A.ö. Krankenhaus der Landeshauptstadt St. Pölten
City
St. Poelten
ZIP/Postal Code
A-3100
Country
Austria
Facility Name
Klinikum Kreuzschwestern Wels GmbH
City
Wels
ZIP/Postal Code
A-4600
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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