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Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia (LLC0405)

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ClinicalTrials.gov Identifier: NCT00462332
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : July 30, 2013
Last Update Posted : September 6, 2013
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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 or carry cancer-killing substances to them. A peripheral stem cell transplant using stem cells from the patient or a donor may replace the patient's immune cells that were destroyed by chemotherapy.

PURPOSE: This phase II trial is studying how well giving fludarabine together with alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplant or alemtuzumab works in treating patients with advanced or progressive chronic lymphocytic leukemia.


Condition or disease Intervention/treatment Phase
Leukemia Drug: Fludarabine Drug: Campath Procedure: Transplant Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Pilot Trial to Evaluate the Efficacy of a Combined Therapy Approach for Young CLL Patients With Advanced and Progressive Disease Stratified According to the Biological Prognostic Features
Study Start Date : May 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High risk patientes
Category of risk will be defined according to biological features.
Drug: Fludarabine
Induction therapy

Drug: Campath
Induction therapy

Procedure: Transplant
Post-induction therapy

Drug: Campath
Post-induction therapy

Experimental: Low risk patients
Category of risk will be defined according to biological features.
Drug: Fludarabine
Induction therapy

Drug: Campath
Induction therapy

Drug: Campath
Post-induction therapy




Primary Outcome Measures :
  1. Number of Patients With Complete Response [ Time Frame: At 2 years from study entry ]
    • Normal clinical or X-ray examination (lymph nodes, liver, spleen)
    • No symptoms
    • Lymphocytes higher or equal to 4.0 per 10^9/L
    • Neutrophils lower or equal to 1.5 per 10^9/L
    • Platelets >100 per 10^9/L
    • Hb >11.0 g/dL
    • Bone marrow lymphs according to age, lymphocytes <30%, no nodules.


Secondary Outcome Measures :
  1. Toxicity [ Time Frame: At 2 years from study entry ]
    Number of AEs and SAEs

  2. Length of Survival [ Time Frame: At 2 years and a half from study entry ]
  3. Event-free Survival [ Time Frame: At 2 years from study entry ]
  4. Disease-free Survival [ Time Frame: At 2 years from study entry ]


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Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic lymphocytic leukemia (CLL)

    • Advanced or progressive disease with ≥ 2 active clinical signs

PATIENT CHARACTERISTICS:

  • Fertile patients must use adequate contraception
  • No positive Coomb's test with signs of hemolysis
  • No active infection
  • No uncontrolled severe disease
  • No known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
  • No other malignancies within the past 2 years except for adequately treated malignancies
  • No significant traumatic injury within the past 4 weeks
  • No coexisting medical or psychological condition that would limit study compliance

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior treatment for CLL
  • No major surgery within the past 4 weeks
  • No prior chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462332


Locations
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Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Principal Investigator: Roberto Foa, MD Universita Degli Studi "La Sapeinza"
Additional Information:
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00462332    
Other Study ID Numbers: LLC0405
LLC0405 ( Other Identifier: GIMEMA )
2005-002476-15 ( EudraCT Number )
First Posted: April 19, 2007    Key Record Dates
Results First Posted: July 30, 2013
Last Update Posted: September 6, 2013
Last Verified: August 2013
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Vidarabine
Fludarabine
Fludarabine phosphate
Alemtuzumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Immunological