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Status:

COMPLETED

Alemtuzumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia

Lead Sponsor:

German CLL Study Group

Conditions:

Chronic Lymphocytic Leukemia

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them...

Detailed Description

OBJECTIVES: * To determine the safest dose of alemtuzumab as consolidation therapy in patients in second remission after fludarabine phosphate alone; fludarabine phosphate and cyclophosphamide; fluda...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Inclusion criteria:
  • Diagnosis of B-cell chronic lymphocytic leukemia (B-CLL)
  • Disease in complete or partial remission after completion of 4-6 courses of second-line cytoreductive therapy no less than 90 days and no more than 150 days ago
  • Second-line cytoreductive therapy must comprise 1 of the following regimens:
  • Fludarabine phosphate alone (F)
  • Fludarabine phosphate and cyclophosphamide (FC)
  • Fludarabine phosphate, cyclophosphamide, and rituximab (FCR)
  • Bendamustine hydrochloride alone (B)
  • Bendamustine hydrochloride and rituximab chemotherapy (BR)
  • Complete minimal residual disease response defined by the following:
  • At least negativity of 4-color-cytometry and/or even PCR-amplifiable clonal CDR III rearrangement of the IgV\_H
  • For PCR analysis, blood sample need to be taken at beginning or during second-line cytoreductive therapy before achievement of a clinical complete remission
  • Disease not refractory to first-line F/FC/FCR/B/BR if received such therapy
  • Exclusion criteria:
  • Presence of bulky lymph nodes (\> 5 cm) after second-line F/FC/FCR/B/BR
  • Clinically apparent autoimmune cytopenia (i.e., autoimmune hemolytic anemia, autoimmune thrombocytopenia, or pure red cell aplasia)
  • CNS involvement with B-CLL
  • PATIENT CHARACTERISTICS:
  • Inclusion criteria:
  • ECOG performance status 0-1
  • ANC ≥ 1,500/µL
  • Platelets ≥ 50,000/µL
  • Creatinine ≤ 1.5 times the upper normal limit (ULN)
  • Conjugated bilirubin ≤ 2 times ULN
  • Thyroid function normal
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Exclusion criteria:
  • Severe infection during second-line treatment with F/FC/FCR/B/BR, meeting any 1 of the following criteria:
  • Any episode of NCI grade 4 infection
  • More than 1 episode of NCI grade 3 infection
  • Medical condition requiring long-term use of oral corticosteroids for more than 1 month
  • Active bacterial, viral, or fungal infection
  • HIV, hepatitis B virus, and/or hepatitis C virus-positive serum status
  • Concurrent severe diseases that exclude the administration of protocol therapy, including any of the following:
  • NYHA class III-IV heart insufficiency
  • Severe chronic obstructive lung disease with hypoxemia
  • Severe ischemic cardiac disease
  • Active secondary malignancy other than B-CLL prior to the study
  • Known hypersensitivity or anaphylactic reaction against murine proteins or one of the drug components
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No more than 2 prior chemotherapies, including F/FC/FCR/B/BR therapy
  • No more than 1 pretreatment (before second-line therapy) with chlorambucil or F/FC/FCR/B/BR
  • No chemotherapy or radiotherapy for any neoplastic disease other than B-CLL prior to the study

Exclusion

    Key Trial Info

    Start Date :

    November 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 17 2012

    Estimated Enrollment :

    13 Patients enrolled

    Trial Details

    Trial ID

    NCT00634881

    Start Date

    November 1 2003

    End Date

    February 17 2012

    Last Update

    June 13 2019

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, Germany, D-50924

    2

    Klinikum Barnim GmbH, Werner Forssmann Krankenhaus

    Eberswalde, Germany, 16225

    3

    Universitatsklinikum Heidelberg

    Heidelberg, Germany, D-69115

    4

    Klinikum Lippe - Lemgo

    Lemgo, Germany, D-32657