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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


Phase 2
19 Years
75 Years
Open (Enrolling)
Both
B-Cell Chronic Lymphocytic Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability

Outcome Time Frame:

within the duration of study

Safety Issue:

Yes

Principal Investigator

Richard Greil, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Austria: Agency for Health and Food Safety

Study ID:

FLUSALEM

NCT ID:

NCT00565981

Start Date:

March 2004

Completion Date:

December 2008

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • B-CLL
  • refractory
  • molecular profiling
  • alemtuzumab
  • fludarabinephosphate
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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