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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00565981
Recruitment Status : Completed
First Posted : November 30, 2007
Last Update Posted : December 7, 2017
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie

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.

Condition or disease Intervention/treatment Phase
B-cell Chronic Lymphocytic Leukemia Drug: Fludarabine phosphate Drug: Alemtuzumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2004
Actual Primary Completion Date : February 13, 2008
Actual Study Completion Date : February 13, 2008

Arm Intervention/treatment
Experimental: 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
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®

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

Secondary Outcome Measures :
  1. Time to retreatment [ Time Frame: within duration of trial ]
  2. Overall survival [ Time Frame: within duration of trial ]
  3. Response in lymphatic compartments [ Time Frame: within duration of trial ]
  4. Molecular response/ immunologic MRD response [ Time Frame: within duration of trial ]
  5. Quality of Life [ Time Frame: within duration of trial ]

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00565981

Landeskrankenhaus Feldkirch
Feldkirch, Austria, A-6806
A.ö. Landeskrankenhaus Fürstenfeld
Fürstenfeld, 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

Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie Identifier: NCT00565981     History of Changes
Other Study ID Numbers: FLUSALEM
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

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
Antiviral Agents
Anti-Infective Agents