D-ALBA Frontline Sequential Dasatinib and Blinatumomab in Adult Philadelphia Positive Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT02744768|
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Drug: Dasatinib Drug: Blinatumomab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||D-ALBA Front-Line Sequential Treatment of Adult Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients With Dasatinib and the Bispecific Monoclonal Antibody Blinatumomab|
|Actual Study Start Date :||May 31, 2017|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Adult Ph+ ALL (≥18 years old, with no upper age limit) patients will begin treatment with Dasatinib, 140 mg/day, from day 1 to day +84. Prednisone (PDN) will be administered from day -6 to day +0 (during which the presence of the BCR/ABL1 alteration will be established), at escalating doses up to 60 mg/m2; PDN will be continued up to day +24 and progressively tapered up to day +31.
HLA typing will be performed immediately after the diagnosis for eligible patients.
MRD will be evaluated by RT-PCR at fixed time points (days +22, +45, +57) during the induction and at day +85, the latter for molecular response evaluation.
Adult Ph+ ALL (≥18 years old, with no upper age limit) patients will begin treatment with Dasatinib, 140 mg/day, from day 1 to day +84.
patients in CHR will receive Blinatumomab at a dose of 15 µg/m²/day as continuous intravenous infusion (CIVI) at a constant flow rate for four weeks, followed by a two-week infusion-free interval, defined as one treatment cycle. At least 2 cycles should be administered, up to a maximum of 5 cycles, if deemed necessary.
- Number of patients who achieve Minimal Residual Disease (MRD) negativity upon treatment [ Time Frame: After 11 months from study entry ]In particular, after 2 cycles of blinatumomab. Minimal Residual Disease (MRD) negativity is intended as Complete Molecular Remission (CMR)
- Number of patients completing the 2 cycles of blinatumomab and alive in first complete hematologic remission (CHR) [ Time Frame: From day +85 at 12 months ]
- Number of patients at Complete Molecular Response (CMR) [ Time Frame: At day +22, +45, +57 and +85 from study entry ]
- Number of months of the CMR [ Time Frame: At 12 and 24 months ]
- Number of patients in Overall Survival (OS) [ Time Frame: At 12 and 24 months ]
- Number of grade >3 adverse events [ Time Frame: At 12 and 24 months ]
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): NCT02744768
|Contact: Paola Fazi||+39 firstname.lastname@example.org|
|Contact: Enrico Crea||+39 email@example.com|
|Study Chair:||Roberto Foà||Policlinico Umberto I, Hematology Department.|