Eine internationale Phase 3 Studie für Philadelphia Chromosom-positive akute lymphoblastische Leukämie (Ph+ ALL), die Imatinib in Kombination mit zwei verschiedenen zytotoxischen Chemotherapien untersucht.

Pharmaceutical Form:
INN or Proposed INN: DEXAMETHASONE
CAS Number: 50-02-2
Current Sponsor code: DEX
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 0,5-1

Pharmaceutical Form:
INN or Proposed INN: DEXAMETHASONE
CAS Number: 50-02-2
Current Sponsor code: DEX
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 0,5-1

Pharmaceutical Form:
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Current Sponsor code: PDN
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Pharmaceutical Form:
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Current Sponsor code: PDN
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Pharmaceutical Form:
INN or Proposed INN: VINCRISTINE
CAS Number: 57-22-7
Current Sponsor code: VCR
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Pharmaceutical Form:
INN or Proposed INN: VINCRISTINE
CAS Number: 57-22-7
Current Sponsor code: VCR
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Trade Name: CERUBIDINE 20 mg, poudre pour solution pour perfusion
Pharmaceutical Form:
INN or Proposed INN: DAUNORUBICIN
CAS Number: 20830-81-3
Current Sponsor code: DAUN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Trade Name: CERUBIDINE 20 mg, poudre pour solution pour perfusion
Pharmaceutical Form:
INN or Proposed INN: DAUNORUBICIN
CAS Number: 20830-81-3
Current Sponsor code: DAUN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Pharmaceut

Gender:
Female: yes
Male: yes

Inclusion criteria:
1.Enrollment on National ALL protocol.
2.Age > 1 year and < 21 years at ALL diagnosis.
3. BCR-ABL1 fusion: newly diagnosed ALL (B-ALL or T-ALL) or mixed
phenotypic acute leukemia
4. ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABLclass fusions
5. BCR-ABL1 patients must have previously started Induction therapy, which includes vincristine, a corticosteroid, usually PEG-L-Asparaginase, with or without anthracycline, and/or other standard cytotoxic chemotherapy.
6. BCR-ABL1 patients have not received more than 14 days of multiagent Induction therapy beginning with the first dose of vincristine.
7. BCR-ABL1 patients may have started imatinib prior to study entry but have
not received more than 14 days of imatinib.
8. ABL-class fusion patients must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy.
9. ABL-class fusion patients may have started imatinib during Induction IA, at the same time of or after the first vincristine dose.
10.Performance status corresponding to ECOG scores of 0, 1, or 2.
11.Adequate liver function.
12.Adequate cardiac function.
13.Adequate renal function.


3.Newly diagnosed ALL (B-ALL or T-ALL)or mixed phenotypic acute leukemia (MPAL meeting 2016 WHO definition) with definitive evidence of BCR-ABL1 fusion by karyotype, FISH and/or RT-PCR.
4.Previous start of Induction therapy which includes vincristine, a corticosteroid, usually PEG-L-Asparaginase, with or without anthracycline, and/or other standard cytotoxic chemotherapy.
5.Administration of no more than 14 days of multiagent Induction therapy beginning with the first dose of vincristine.
6.Administration of no more than 14 days of imatinib.
7.Performance status corresponding to ECOG scores of 0, 1, or 2.
8.Adequate liver function.
9.Adequate cardiac function.
10.Adequate renal function.

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.Known history of chronic myelogenous leukemia (CML).
2.ALL developing after a previous cancer treated with cytotoxic chemotherapy.
3.Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation.
4.Down syndrome.
5.Pregnancy.
6.Breast feeding.
7.Patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of treatment according to protocol.
8.Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block.
9.Prior treatment with dasatinib, or any TKI inhibitor other than imatinib.