Internationales kooperatives Behandlungsprotokoll für Kinder und Jugendliche mit akuter lymphoblastischer Leukämie (ALL)

Pharmaceutical Form:
INN or Proposed INN: MERCAPTOPURINE
CAS Number: 50-44-2

Pharmaceutical Form:
INN or Proposed INN: TIOGUANINE
CAS Number: 154-42-7

Trade Name: Erwinase
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CRISANTASPASE
CAS Number: 9015-68-3
Current Sponsor code: Erwinase
Other descriptive name: CRISANTASPASE
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 10000-

Trade Name: Oncaspar
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PEGASPARGASE
CAS Number: 130167-69-0
Current Sponsor code: PEG-Asparaginase
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 3750-

Pharmaceutical Form:
INN or Proposed INN: DAUNORUBICIN
CAS Number: 20830-81-3

Pharmaceutical Form:
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Other descriptive name: PREDNISOLONE

Pharmaceutical Form:
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Other descriptive name: PREDNISONE

Pharmaceutical Form:
INN or Proposed INN: CYCLOPHOSPHAMIDE
CAS Number: 50-18-0

Pharmaceutical Form:
INN or Proposed INN: ETOPOSIDE PHOSPHATE
CAS Number: 117091-64-2
Other descriptive name: ETOPOSIDE PHOSPHATE

Pharmaceutical Form:
INN or Proposed INN: DEXAMETHASONE
CAS Number: 50-02-2

Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Other descriptive name: METHOTREXATE

Pharmaceutical Form:
INN or Proposed INN: CYTARABINE
CAS Number: 147-94-4
Other descriptive name: CYTARABINE

Pharmaceutical Form:
INN or Proposed INN: ETOPOSIDE
CAS Number: 33419-42-0
Other descriptive name: ETOPOSIDE

Pharmaceutical Form:
INN or Proposed INN: VINCRISTINE
CAS Number: 57-22-7

Pharmaceutical Form:
INN or Proposed INN: IFOSFAMIDE
CAS Number: 3778-73-2

Phar

Gender:
Female: yes
Male: yes

Inclusion criteria:
- newly diagnosed acute lymphoblastic leukemia, from 1st September 2023 onwards only acute lymphoblastic leukemia with T-cell phenotype or
- newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria:
? biphenotypic with a dominant T or B lineage assignment,from 1st September 2023 onwards only those with a dominant T lineage assignment,
?bilineal either with a dominant lymphoblastic (from 1st September 2023 onwards only T lymphoblastic) population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen
- newly diagnosed acute undifferentiated leukemia
- age < 18 years (up to 17 years and 365 days) at the day of diagnosis
- patient enrolled in a participating center
- written informed consent to trial participation and transfer and processing of data

Are the trial subjects under 18? yes
Number of subjects for this age range: 5000
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:
- Ph+ (BCR-ABL1 or t(9;22)-positive) ALL
- bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (= 10% of total cells) blast subset
- pre-treatment with cytostatic drugs
- glucocorticoid pre-treatment with = 1 mg/kg/d Prednisolone equivalent for more than two weeks during the last month before diagnosis
- treatment started according to another protocol
- underlying diseases that does not allow treatment according to the protocol
- ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
- evidence of pregnancy or lactation period
- Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
- participation in another clinical trial that interferes with the protocol
-other condition (either pre-existing or related to leukemia biology as present at diagnosis) or circumstances that significantly conflict with the treatment according to the protocol