International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia

Phase 3

Recruiting

• Conditions: C91.0; Acute lymphoblastic leukaemia [ALL]

• Registration Number: DRKS00015289
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein Campus Kiel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

newly diagnosed acute lymphoblastic leukemia or
- newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria:
• biphenotypic with a dominant T or B lineage assignment
• bilineal either with a dominant 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

Exclusion Criteria

Ph+ (BCR-ABL1 or t(9;22)-positive) ALL2
- 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 disease 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 except for add-on trials within the scope of supportive care approved by the sponsor
- live vaccine immunization within 2 weeks before start of protocol treatment
- 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For the randomized study questions, the primary endpoint will be the time from randomization until the first event defined as follows:<br>Randomization R-eHR, R-HR and R-T: Cytomorphological or molecular non-response (resistance to protocol treatment, considered as event at day zero), relapse, second malignancy or death from any cause. This will be called EFS time.<br>Randomization R-MR: Relapse, second malignancy or death from any cause. This will be called DFS time.

Secondary Outcome Measures

Name	Time	Method
- Survival starting at the same time point as the EFS/DFS<br>- Frequency and incidence of treatment-related mortality in induction or CCR<br>- Frequency and incidence of AE of interest and SAE in specific protocol phases, randomized arms and overall during follow-up<br>- MRD load after the randomized treatment phases (R-eHR, R-HR, R-MR and R-T)<br>- MRD load after the first/second cycle of Blinatumomab or after the HR-2’/HR-3’ block (R-HR)<br>- Proportion of patients with poor MRD response to the first Blinatumomab cycle (Blinatumomab Poor-Response”) (R-HR)