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 because the information has not been verified recently.
Verified June 2008 by Arbeitsgemeinschaft medikamentoese Tumortherapie.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT00565981
First received: November 29, 2007
Last updated: June 4, 2008
Last verified: June 2008
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
  • Complete and overall response rate [ Time Frame: within the duration of study ] [ Designated as safety issue: Yes ]
  • Infections grade III, IV [ Time Frame: within the duration of study ] [ Designated as safety issue: Yes ]
  • Rate of CMV reactivation [ Time Frame: within the duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to retreatment [ Time Frame: within duration of trial ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: within duration of trial ] [ Designated as safety issue: No ]
  • Response in lymphatic compartments [ Time Frame: within duration of trial ] [ Designated as safety issue: No ]
  • Molecular response/ immunologic MRD response [ Time Frame: within duration of trial ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: within duration of trial ] [ Designated as safety issue: No ]

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®
  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565981

Locations
Austria
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
Schering-Plough
Investigators
Principal Investigator: Richard Greil, MD IIIrd Medical Department for Hematology, Oncology, Rheumatology, Infectiology and Hemostasiology at the Medical University of Salzburg
  More Information

No publications provided

Responsible Party: Prof. Dr. Richard Greil, Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT00565981     History of Changes
Other Study ID Numbers: FLUSALEM
Study First Received: November 29, 2007
Last Updated: June 4, 2008
Health Authority: Austria: Agency for Health and Food Safety
Austria: Ethikkommission

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
B-CLL
refractory
molecular profiling
alemtuzumab
fludarabinephosphate

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine
Fludarabine monophosphate
Alemtuzumab
Campath 1G
Vidarabine
Antibodies, Neoplasm
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 29, 2014