Ponatinib With Chemotherapy for Young Adults Ph Positive Acute Lymphoblastic Leukemia
Status:
Active, not recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
Evaluate the response (complete hematologic response [CHR], complete cytogenetic response
[CCyR], major molecular response [MMR] and complete molecular response [CMR] of the
combination of ponatinib with standard chemotherapy (according to PETHEMA ALL Ph08 trial) in
young patients with Ph+ (BCR-ABL) ALL.
All patients are treated with:
Pre-phase (maximum 7 days, -7 to -1):
Prednisone 60 mg/m2/day IV over 7 days (-7 a -1) and triple intrathecal therapy (TIT)
(Methotrexate [MTX]: 12 mg, ARA-C: 30 mg, hydrocortisone: 20 mg). 2. Induction (day 1 to day
28 or up to hematological recovery) Vincristine (VCR): 1.5 mg/m2 (maximum 2 mg) IV days 1, 8,
15 and 22. Daunorubicin (DNR): 45 mg/m2 IV days 1, 8, 15 and 22. Prednisone (PDN): 60
mg/m2/day, IV or PO, days 1 to 27. Ponatinib 30 mg, PO from day 1 to consolidation. TIT, days
1 and 22. 3. Consolidation (day 1 to day 63) Mercaptopurine (MP): 50 mg/m2, PO days 1 to 7,
28 to 35 and 56 to 63. MTX: 1,5 g/m2, IV (24 h continuous infusion) days 1, 28 and 56. VP-16:
100 mg/m2/12 h, IV, days 14 and 42. ARA-C: 1000 mg/m2/12 h, IV, days 14-15 and 42-43. TIT
(MTX: 12 mg, ARA-C: 30 mg, hydrocortisone: 20 mg), , days 1, 28 and 56. Ponatinib 30 mg/d PO,
from day 1 to 15 days before HSCT. 4. HSCT (performed ideally within 1 month from the end of
consolidation). AlloHSCT preferred over autoHSCT (autoHSCT only indicated if alloHSCT not
feasible). Myeloablative conditioning with cyclophosphamide and total body irradiation (TBI)
whenever possible. 5. Post HSCT therapy After alloHSCT. Frequent monitoring of MRD (every
month). I After autoHSCT: Frequent monitoring of MRD (every month).