This study will enroll adult de novo Ph+ acute lymphoblastic leukemia (ALL) patients (≥18 years, ≤60 years). Induction treatment will consist of 12 weeks of Dasatinib oral administration (140 mg QD). Patients will initiate treatment with steroids 7 days prior to starting Dasatinib and will continue up to day 31. Patients will continue treatment with Dasatinib up to day 84, except for disease progression, intolerable toxicity, or withdrawal from study.
This study will enroll adult de novo Ph+ acute lymphoblastic leukemia (ALL) patients (≥18 years, ≤60 years). Induction treatment will consist of 12 weeks of Dasatinib oral administration (140 mg QD). Patients will initiate treatment with steroids 7 days prior to starting Dasatinib and will continue up to day 31. Patients will continue treatment with Dasatinib up to day 84, except for disease progression, intolerable toxicity, or withdrawal from study. Thereafter: * patients in hematological and molecular CR will receive a post-remissional treatment consisting of Dasatinib alone for a 6 months period * patients in hematological CR with persistence of molecular disease will be allografted or, if not eligible or a donor is not available, treated with 2 cycles of a Clofarabine-Cyclophosphamide schedule. After allograft: * MRD negative patients (i.e. in CHR and PCR negative) will receive a 6 months Dasatinib maintenance treatment; * MRD positive patients (i.e. in CHR and PCR positive) will receive Dasatinib as maintenance treatment until relapse or progression. Patients not transplanted and treated with Clofarabine/Cyclophosphamide will also receive Dasatinib as maintenance treatment until relapse or progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Total therapy approach
The primary objective of the trial is to estimate the feasibility of a total therapy strategy in de novo adult Ph positive ALL.
The primary endpoint is the rate of patients alive in CHR who have completed the trial treatment according to the therapeutic strategy;
Time frame: at 42 months
The median value of the minimum of PCR levels achieved in each patient during the Dasatinib treatment within day +85, whenever achieved from the start of the Dasatinib.
Time frame: at 42 months
The rate of patients who become PCR negative after Dasatinib induction.
Time frame: at 42 months
Out of patients who become PCR negative after induction, the rate of patients who remain persistently negative during maintenance treatment with Dasatinib (without chemotherapy or allogeneic transplant).
Time frame: at 42 months
The median value of the minimum of PCR levels achieved in each patient after an allogeneic transplant or Clofarabine-Cyclophosphamide treatment as consolidation therapy.
Time frame: at 42 months
The rate of patients alive in CHR who have completed the maintenance program with Dasatinib after an allogeneic transplant or two cycles of Clofarabine-Cyclophosphamide as consolidation therapy.
Time frame: at 42 months
Disease free survival estimation starting from the date of evaluation of CHR.
Time frame: at 42 months
Cumulative incidence of relapse estimation starting from the date of evaluation of CHR.
Time frame: at 42 months
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Centro Oncologico Basilicata
Rionero in Vulture, Potenza, Italy
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona, Italy
Dipartimento Area Medica P.O.
Ascoli Piceno, Italy
Az. Ospedaliera S. G. Moscati
Avellino, Italy
Unità Operativa Ematologia 1 - Università degli Studi di Bari
Bari, Italy
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
Bologna, Italy
Osp. Reg. A. Di Summa
Brindisi, Italy
CTMO - Ematologia - Ospedale "Binaghi"
Cagliari, Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, Italy
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro, Italy
...and 41 more locations
Overall survival estimation starting from date of inclusion.
Time frame: at 42 months