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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00462332
First received: April 18, 2007
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Leukemia
Drug: Fludarabine
Drug: Campath
Procedure: Transplant
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • Number of Patients With Complete Response [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]
    • 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:
  • Toxicity [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: Yes ]
    Number of AEs and SAEs

  • Length of Survival [ Time Frame: At 2 years and a half from study entry ] [ Designated as safety issue: No ]
  • Event-free Survival [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]
  • Disease-free Survival [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: May 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 60 Years
Genders Eligible for Study:   Both
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
  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: NCT00462332

Locations
Italy
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
Ospedale Sant' Eugenio
Rome, Italy, 00144
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, Italy, 00168
Università Degli Studi "La Sapienza"
Rome, Italy, 00161
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Italy, 00133
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
Investigators
Principal Investigator: Roberto Foa, MD Universita Degli Studi "La Sapeinza"
  More Information

Additional Information:
No publications provided

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00462332     History of Changes
Other Study ID Numbers: LLC0405, LLC0405, 2005-002476-15
Study First Received: April 18, 2007
Results First Received: August 20, 2012
Last Updated: August 20, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia

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

ClinicalTrials.gov processed this record on November 24, 2014