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NCT Number: NCT00565981

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

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.

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Key information

Conditions

B-cell Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Landeskrankenhaus Feldkirch, Feldkirch, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fludarabine phosphate

Drug

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

Other names: Fludara®

Alemtuzumab

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

Other names: MabCampath®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Other

Collaborators

  • Schering-Plough

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Nov 30, 2007
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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