Trials / Unknown
UnknownNCT02744768
D-ALBA Frontline Sequential Dasatinib and Blinatumomab in Adult Philadelphia Positive Acute Lymphoblastic Leukemia
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims at exploring the activity of a frontline approach based on dasatinib plus steroids administration as induction treatment, followed by the infusion of Blinatumomab, in adult Ph+ ALL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dasatinib | 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. |
| DRUG | Blinatumomab | Upon induction: 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. |
Timeline
- Start date
- 2017-05-31
- Primary completion
- 2021-06-01
- Completion
- 2021-06-01
- First posted
- 2016-04-20
- Last updated
- 2018-03-22
Locations
34 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT02744768. Inclusion in this directory is not an endorsement.