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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Arbeitsgemeinschaft medikamentoese Tumortherapie.
Recruitment status was:  Active, not recruiting
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie Identifier:
First received: November 29, 2007
Last updated: June 4, 2008
Last verified: June 2008

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.

Condition Intervention Phase
B-Cell Chronic Lymphocytic Leukemia
Drug: Fludarabine phosphate
Drug: Alemtuzumab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: within the duration of study ]
  • Complete and overall response rate [ Time Frame: within the duration of study ]
  • Infections grade III, IV [ Time Frame: within the duration of study ]
  • Rate of CMV reactivation [ Time Frame: within the duration of study ]

Secondary Outcome Measures:
  • Time to retreatment [ Time Frame: within duration of trial ]
  • Overall survival [ Time Frame: within duration of trial ]
  • Response in lymphatic compartments [ Time Frame: within duration of trial ]
  • Molecular response/ immunologic MRD response [ Time Frame: within duration of trial ]
  • Quality of Life [ Time Frame: within duration of trial ]

Estimated Enrollment: 28
Study Start Date: March 2004
Estimated Study Completion Date: December 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fludarabine phosphate
    orally, 40 mg/m2 d1-3 q4w, x4 cycles
    Other Name: 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 Name: MabCampath®

Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00565981

Landeskrankenhaus Feldkirch
Feldkirch, Austria, A-6806
A.ö. Landeskrankenhaus Fürstenfeld
Fuerstenfeld, Austria, A-8280
Universitätsklinik Innsbruck/ Klinik für Innere Medizin
Innsbruck, Austria, A-6020
A.ö. Landeskrankenhaus Leoben
Leoben, Austria, A-8700
Krankenhaus der Stadt Linz
Linz, Austria, A-4020
St. Johanns LK
Salzburg, Austria, A-5020
A.ö. Krankenhaus der Landeshauptstadt St. Pölten
St. Poelten, Austria, A-3100
Klinikum Kreuzschwestern Wels GmbH
Wels, Austria, A-4600
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Principal Investigator: Richard Greil, MD IIIrd Medical Department for Hematology, Oncology, Rheumatology, Infectiology and Hemostasiology at the Medical University of Salzburg
  More Information

Responsible Party: Prof. Dr. Richard Greil, Arbeitsgemeinschaft medikamentoese Tumortherapie Identifier: NCT00565981     History of Changes
Other Study ID Numbers: FLUSALEM
Study First Received: November 29, 2007
Last Updated: June 4, 2008

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
molecular profiling

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017