Leukemia Clinical Trial
— LLC0405Official 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
Verified date | August 2013 |
Source | Gruppo Italiano Malattie EMatologiche dell'Adulto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 86 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 60 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo | Alessandria | |
Italy | Universita Degli Studi di Bari | Bari | |
Italy | Universita Cattolica del Sacro Cuore - Campobasso | Campobasso | |
Italy | Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto" | Catania | |
Italy | Ospedale Regionale A. Pugliese | Catanzaro | |
Italy | Ospedale Civile Cosenza | Cosenza | |
Italy | Universita di Ferrara | Ferrara | |
Italy | Azienda Ospedaliera di Firenze | Firenze | |
Italy | Ospedale San Martino | Genova | |
Italy | 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 | Azienda Ospedaliera - Universitaria di Modena | Modena | |
Italy | U.O. Ematologia Clinica - Azienda USL di Pescara | Pescara | |
Italy | Azienda Ospedaliera Bianchi Melacrino Morelli | Reggio Calabria | |
Italy | Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Rome | |
Italy | Ospedale Sant' Eugenio | Rome | |
Italy | Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | Rome | |
Italy | Università Degli Studi "La Sapienza" | Rome | |
Italy | 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 | Policlinico Universitario Udine | Udine |
Lead Sponsor | Collaborator |
---|---|
Gruppo Italiano Malattie EMatologiche dell'Adulto |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients With Complete Response | 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. |
At 2 years from study entry | No |
Secondary | Toxicity | Number of AEs and SAEs | At 2 years from study entry | Yes |
Secondary | Length of Survival | At 2 years and a half from study entry | No | |
Secondary | Event-free Survival | At 2 years from study entry | No | |
Secondary | Disease-free Survival | At 2 years from study entry | No |
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