International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia

Phase 1

• Conditions: acute lymphoblastic leukemia in children and adolescents <18 yearsof age; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001935-12-DE
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein, Campus Kiel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-19
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified