BLINATUMOMAB for Acute lymphoblastic leukaemia | Mixed phenotype acute leukaemia

Inclusion criteria

• {"criterion_text":"- newly diagnosed acute lymphoblastic leukemia, from 1st September 2023 onwards only acute lymphoblastic leukemia with T-cell phenotype or\n- 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\n- newly diagnosed acute undifferentiated leukemia\n- age < 18 years (up to 17 years and 365 days) at the day of diagnosis\n- patient enrolled in a participating center\n- written informed consent to trial participation and transfer and processing of data"}

Exclusion criteria

• {"criterion_text":"- Ph+ (BCR-ABL1 or t(9;22)-positive) ALL\n- bilineal leukemia with a lymphoblastic and a separate nonlymphoblastic (≥ 10% of total cells) blast subset\n- pre-treatment with cytostatic drugs\n- glucocorticoid pre-treatment with ≥ 1 mg/kg/d Prednisolone equivalent for more than two weeks during the last month before diagnosis\n- treatment started according to another protocol\n- underlying diseases that does not allow treatment according to the protocol\n- ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy\n- evidence of pregnancy or lactation period\n- Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of antileukemic therapy\n- participation in another clinical trial that interferes with the protocol\n- 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"}

Primary endpoints

• {"endpoint_text":"- For the randomized study questions, the primary endpoint will be the time from randomization until the first event defined as follows: 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.","definition_or_measurement_approach":"Time from randomization to first event (cytomorphological or molecular non-response, relapse, second malignancy, or death) — defined as EFS time for R-eHR, R-HR and R-T."}
• {"endpoint_text":"- Randomization R-MR: Relapse, second malignancy or death from any cause. This will be called DFS time.","definition_or_measurement_approach":"Time from randomization to relapse, second malignancy or death — defined as DFS time for R-MR."}
• {"endpoint_text":"- EFS and DFS time: end of study","definition_or_measurement_approach":"EFS and DFS times evaluated until end of study."}

Secondary endpoints

• {"endpoint_text":"- Survival starting at the same time point as the EFS/DFS","definition_or_measurement_approach":"Overall survival measured from same timepoint as EFS/DFS."}
• {"endpoint_text":"- Frequency and incidence of treatment-related mortality in induction or CCR","definition_or_measurement_approach":"Incidence and frequency counts of treatment-related mortality during induction or CCR phases."}
• {"endpoint_text":"- Frequency and incidence of AE of interest and SAE in specific protocol phases, randomized arms and overall during follow-up","definition_or_measurement_approach":"Counts and rates of specified AEs and SAEs by protocol phase and treatment arm during follow-up."}
• {"endpoint_text":"- MRD load after the randomized treatment phases (R-eHR, R-HR, R-MR and R-T)","definition_or_measurement_approach":"Measurement of MRD load after randomized treatment phases (assessed by molecular/cytomorphological MRD assays as defined in protocol)."}
• {"endpoint_text":"- MRD load after the first/second cycle of Blinatumomab or after the HR 2'/HR 3' block (R-HR)","definition_or_measurement_approach":"MRD measured after Blinatumomab cycles or after specified HR blocks."}
• {"endpoint_text":"- Proportion of patients with poor MRD response to the first Blinatumomab cycle (\"Blinatumomab Poor-Response\") (R HR)","definition_or_measurement_approach":"Proportion (%) of patients meeting protocol-defined criteria for poor MRD response after first Blinatumomab cycle (per protocol section referenced)."}

Italy

Earliest CTIS Part Ii Submission Date

13-06-2024

Latest Decision Or Authorization Date

13-03-2025

Processing Time Days

273

Number Of Participants

1700

Slovakia

Earliest CTIS Part Ii Submission Date

13-06-2024

Latest Decision Or Authorization Date

28-02-2025

Processing Time Days

259

Number Of Participants

150

Austria

Earliest CTIS Part Ii Submission Date

13-06-2024

Latest Decision Or Authorization Date

13-03-2025

Processing Time Days

273

Number Of Participants

250

Czechia

Earliest CTIS Part Ii Submission Date

13-06-2024

Latest Decision Or Authorization Date

03-03-2025

Processing Time Days

263

Number Of Participants

300

Germany

Earliest CTIS Part Ii Submission Date

03-07-2024

Latest Decision Or Authorization Date

20-03-2025

Processing Time Days

260

Number Of Participants

1850

Primary sponsor

Full Name

Universitaetsklinikum Schleswig-Holstein

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Medizinische Hochschule Hannover","duties_or_roles":"10","organisation_type":"Educational Institution"}
• {"country":"Italy","full_name":"Universita Degli Studi Di Milano Bicocca","duties_or_roles":"10","organisation_type":"Educational Institution"}
• {"country":"Italy","full_name":"Fondazione IRCCS San Gerardo Dei Tintori","duties_or_roles":"1,12,13,5,6","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Medizinische Hochschule Hannover (ZDM-GPOH contact)","duties_or_roles":"6,7","organisation_type":"Educational Institution"}
• {"country":"Austria","full_name":"St. Anna Kinderspital GmbH","duties_or_roles":"12,13,5,6,8","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Austria","full_name":"St. Anna Childrens Cancer Research Institute GmbH","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}
• {"country":"Czechia","full_name":"Fakultni Nemocnice V Motole","duties_or_roles":"1,12,13,5,6,8","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Slovakia","full_name":"Narodny Ustav Detskych Chorob","duties_or_roles":"1,12,13,5,6","organisation_type":"Hospital/Clinic/Other health care facility"}