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Completed

NCT Number: NCT00147901

Fludarabine, Cyclophosphamide, and Alemtuzumab in Patients With B-cell Chronic Lymphatic Leukemia (B-CLL)

This study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia.

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Cologne

Cologne, North Rhine-Westphalia, 50924, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • B-CLL in need of treatment
  • One or two prior prior therapies
  • WHO performance status 0-2

Exclusion criteria

  • Serum creatinine > 1.5 ULN
  • Major organ dysfunctions
  • Pregnant or nursing

Treatment and study plan

FCCam

Drug

After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles

Other names: Fludarabine, Cyclophosphamide, Alemtuzumab

Primary outcomes

  1. Overall response rate (complete and partial response rate)

    Time frame: 28 days after the end of the last cycle

    Response Evaluation has to be done according the the NCI guidelines

Secondary outcomes

  1. Toxicity

    Time frame: 28 days following the last dose of FCCam

  2. MRD response rate

    Time frame: 28 days after the end of the last cycle

  3. Response rate in biological defined risk groups

    Time frame: 28 days after the end of the last cycle

  4. Duration of response

    Time frame: up to 36 months after the end of treatment

  5. Treatment administration (dose intensity)

    Time frame: up to the last day of the last given cycle (day 28 of the 6th cycle)

  6. Overall survival

    Time frame: up to 36 months after the end of treatment

Sponsors and collaborators

Lead sponsor

German CLL Study Group

Other

Collaborators

  • MedacSchering Onkologie
  • University of Cologne

Registry information

Official study title

Multicenter Phase II Trial of Fludarabine and Cyclophosphamide in Combination With Alemtuzumab (FC-Cam) for Patients With Relapsed Chronic Lymphocytic Leukemia - CLL-2L Protocol of the German CLL-Study Group (GCLLSG)

Important dates

Study start
2005
Primary completion
2008
Study completion
2011
First posted
Sep 7, 2005
Registry last updated
Oct 3, 2016

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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