Spots Global Cancer Trial Database for Clofarabine-cyclophosphamide as Salvage Therapy for Refractory and Relapsed Acute Lymphoblastic Leukemia (ALL) Adults
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Clofarabine-cyclophosphamide as Salvage Therapy for Refractory and Relapsed Acute Lymphoblastic Leukemia (ALL) Adults
Official Title: "A Phase II Study With a Sequential Clofarabine-cyclophosphamide Combination Schedule as Salvage Therapy for Refractory and Relapsed Acute Lymphoblastic Leukemia (ALL) in Adult Patients"
Study ID: NCT01462253
Conditions
Interventions
Study Description
Brief Summary: This is a multicentric, prospective pilot trial testing a Clofarabine-Cyclophosphamide combination to treat refractory and first bone marrow relapse adult ALL, for the achievement of a complete remission (CR) and the concurrent evaluation of biological response in ALL cells (minimal residual disease, apoptosis and DNA cell damage, pharmacogenomics).
Detailed Description: The proposed treatment schedule consists of a combination of Clofarabine plus Cyclophosphamide administered over 5 consecutive days (Treatment scheme). This is an open, nonrandomized prospective phase II trial aimed to evaluating (1) activity of this combination in terms of CR rate. * STEP 1. All eligible patients will be screened for the availability of an HLA-matched or partially mismatched compatible HSCT donor, of both family related - or unrelated type (early activation required), including cord blood and haploidentical siblings. Moreover, pre-treatment investigation will include collection and storage of patient ALL cells for specific biological studies relating to sensitivity and response to study chemotherapeutic combination. * STEP 2. Cycle 1 will be applied to all eligible patients once all enrollment criteria are confirmed. * STEP 3. After cycle 1, response will be evaluated. * STEP 4. After remission induction cycle 1, only responsive patients (CR or PR, see below for definitions) could be given cycle 2, according to the opinion of the responsible physician and with a minimum intercycle interval of 4 weeks from day 1 of cycle 1. All NR patients will be declared off study and will not be given a second course with study combination. The suggested treatment following cycle 2 (or cycle 1 if cycle 2 is omitted) is HSCT.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Unità Operativa Ematologia 1 - Università degli Studi di Bari, Bari, , Italy
Divisione di Ematologia - Ospedali Riuniti, Bergamo, , Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi, Bologna, , Italy
Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO, Bolzano, , Italy
Sezione di Ematologia e Trapianti Spedali Civili, Brescia, , Italy
Azienda ASL di Cagliari, Cagliari, , Italy
Ospedale Santa Croce Divisione di Ematologia Cuneo, Cuneo, , Italy
Policlinico di Careggi, Università delgi studi di Firenze, Firenze, , Italy
Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST, Meldola, , Italy
U.O. di Ematologia- Ospedale dell'Angelo - Mestre, Mestre, , Italy
U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele, Milano, , Italy
UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico, Milano, , Italy
Centro Oncologico Modenese - Dipartimento di Oncoematologia, Modena, , Italy
N. Osp. divisione di Ematologia "S.Gerardo dei Tintori", Monza, , Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli", Napoli, , Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia, Napoli, , Italy
Ospedale Cervello, Palermo, , Italy
U.O. Ematologia Clinica - Azienda USL di Pescara, Pescara, , Italy
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia, Pisa, , Italy
Dipartimento Oncologico - Ospedale S.Maria delle Croci, Ravenna, , Italy
Calabria Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli", Reggio Calabria, , Italy
Umberto I di Roma - Dipartimento di Biotecnologie Cellulari ed Ematologia, Roma, , Italy
Complesso Ospedaliero S. Giovanni Addolorata, Roma, , Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia, Roma, , Italy
Università degli Studi - Policlinico di Tor Vergata, Roma, , Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy
SCDO Ematologia 2 AOU Giovanni Battista, Torino, , Italy
Contact Details
Name: Renato BASSAN, Pr.
Affiliation: U.O. di Ematologia- Ospedale dell'Angelo - Mestre
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
