Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL

Not yet recruitingOBSERVATIONAL
Enrollment

150

Participants

Timeline

Start Date

December 25, 2023

Primary Completion Date

December 25, 2028

Study Completion Date

December 25, 2030

Conditions
Lymphoblastic LeukemiaPhiladelphia-Positive ALLAdult ALL
Interventions
DRUG

Vincristine

dose 1.5 mg/m2 at days 1, 8, 15 and 22

DRUG

Dexamethasone

40 mg on days 1-2, 8-9,15-16 and 22-23

DRUG

Imatinib

600 mg per day from 1 to up to 5 years

DRUG

Cytarabine

1000 mg/m2/ on days 1, 3 and 5 of consolidation with 2h infusion

DRUG

Mercaptopurine

50 mg/m2 on days 1 to 28 of maintenance

DRUG

Methotrexate

1000 mg/m2 on day 1 of consolidation with 24h infusion; and 20 mg/m2 on days 1, 8, 15 and 22 of maintenance

DRUG

Ponatinib

15 mg per day from consolidation start up to 5 years

PROCEDURE

allogeneic stem cell transplantation

Allogeneic stem cell transplantation from hematpoietic stem cells progenitors of familiar or not familiar origin. Cord blood transplantation can also be done.

PROCEDURE

Total body irradiation

Fractionated dose with total dose of 12 Gy between days -4 and -1 of allogeneic stem cell transplantation (alloSCT)

DRUG

Cyclophosphamide

60 mg/kg on days -6 and -5 before alloSCT

DRUG

Fludarabine

30 mg/m2 intravenous on days -7, -6, -5 y -4 before alloSCT (alternative to cyclophosphamide)

All Listed Sponsors
lead

PETHEMA Foundation

OTHER

NCT06175702 - Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL | Biotech Hunter | Biotech Hunter