We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00462332
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : July 30, 2013
Last Update Posted : September 6, 2013
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

  Show Detailed Description

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
Primary Completion Date : June 2011
Study Completion Date : June 2011

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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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


  • Diagnosis of chronic lymphocytic leukemia (CLL)

    • Advanced or progressive disease with ≥ 2 active clinical signs


  • 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


  • 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

S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Universita Degli Studi di Bari
Bari, Italy, 70124
Universita Cattolica del Sacro Cuore - Campobasso
Campobasso, Italy, 86100
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, Italy, 95124
Ospedale Regionale A. Pugliese
Catanzaro, Italy, 88100
Ospedale Civile Cosenza
Cosenza, Italy, 87100
Universita di Ferrara
Ferrara, Italy, 44100
Azienda Ospedaliera di Firenze
Firenze, Italy, 50011
Ospedale San Martino
Genova, Italy, 16132
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce, Italy
Azienda Ospedaliera Papardo
Messina, Italy
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
Messina, Italy
Ospedale Maggiore Policlinico
Milano, Italy, 20122
Azienda Ospedaliera - Universitaria di Modena
Modena, Italy, 41100
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria, Italy, 89100
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Italy, 00133
Ospedale Sant' Eugenio
Rome, Italy, 00144
Università Degli Studi "La Sapienza"
Rome, Italy, 00161
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, Italy, 00168
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
Siena, Italy
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Turin, Italy, 10126
Policlinico Universitario Udine
Udine, Italy, 33100
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Principal Investigator: Roberto Foa, MD Universita Degli Studi "La Sapeinza"

Additional Information:
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00462332     History of Changes
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:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents