Clinical trial • Phase III • Oncology
IMATINIB for Acute lymphoblastic leukemia | Philadelphia chromosome-positive acute lymphoblastic leukemia
Phase III trial of IMATINIB for Acute lymphoblastic leukemia | Philadelphia chromosome-positive acute lymphoblastic leukemia.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Acute lymphoblastic leukemia | Philadelphia chromosome-positive acute lymphoblastic leukemia
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Peptide/protein/enzyme
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 18-09-2024
- First CTIS Authorization Date
- 25-10-2024
Trial design
Randomised, imatinib combined with the esphall chemotherapy backbone versus imatinib combined with the cog high-risk (hr) all chemotherapy backbone-controlled Phase III trial in Austria, Belgium, Czechia and others.
- Randomised
- Yes
- Comparator
- Imatinib combined with the EsPhALL chemotherapy backbone versus imatinib combined with the COG high-risk (HR) ALL chemotherapy backbone
- Target Sample Size
- 306
Eligibility
Recruits 306 paediatric patients.
- Pregnancy Exclusion
- 5. Pregnancy
- Vulnerable Population
- The trial includes vulnerable populations (minors). Age-specific subject information sheets and informed consent/assent forms are provided (documents for parents/legal guardians and for children/adolescents across age bands such as under 8, 8-11, 12-17, 15-17 and adults). Consent is obtained from the parent/legal guardian for minors with age-appropriate assent from children/adolescents where applicable; adult participants provide their own informed consent. Multiple country-specific ICFs/translations are available.
Inclusion criteria
- {"criterion_text":"- 1. Patients should be enrolled on National ALL protocol prior to enrollment on EsPhALL2017/COGAALL1631. Regardless of initial frontline protocol baseline diagnostic samples must be available to develop an MRD probe. Diagnostic samples will be collected and analyzed according to the procedures of the National front-line protocol."}
- {"criterion_text":"- 2. > 1 year and < 21 years at ALL diagnosis"}
- {"criterion_text":"- 3. New LLA diagnosis a. type B or T, or mixed phenotypic acute leukemia (MPAL meeting 2016 WHO definition) with definitive evidence of BCR-ABL1 fusion by karyotype, FISH and/or RT-PCR b. type B, with definitive evidence of ABL class fusions identified according to National/Center procedures of each participating country."}
- {"criterion_text":"- 4. Prior Therapy for BCR-ABL1 fusion patients: a. induction therapy, which includes vincristine, a corticosteroid, usually PEG-L-Asparaginase, with or without anthracycline, and/or other standard cytotoxic chemotherapy. b. Not received more than 14 days of multiagent induction therapy beginning with the first dose of vincristine. c. May have started imatinib prior to study entry but have not received more than 14 days of imatinib."}
- {"criterion_text":"- 5. Prior Therapy for ABL-class fusion patients: a. must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy. b. may have started imatinib during Induction IA, at the same time of or after the first vincristine dose."}
- {"criterion_text":"- 6. Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2."}
- {"criterion_text":"- 7. Adequate liver function."}
- {"criterion_text":"- 8. Adequate cardiac function."}
- {"criterion_text":"- 9. Adequate renal function."}
Exclusion criteria
- {"criterion_text":"- 1. Known history of chronic myelogenous leukemia (CML)."}
- {"criterion_text":"- 2. ALL developing after a previous cancer treated with cytotoxic chemotherapy."}
- {"criterion_text":"- 3. Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation"}
- {"criterion_text":"- 4. Down syndrome"}
- {"criterion_text":"- 5. Pregnancy"}
- {"criterion_text":"- 6. Breast Feeding"}
- {"criterion_text":"- 7. Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of treatment according to protocol."}
- {"criterion_text":"- 8. Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block."}
- {"criterion_text":"- 9. Prior treatment with dasatinib, or any TKI inhibitor other than imatinib."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint, DFS, is defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last followup for patients without events","definition_or_measurement_approach":"Defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last followup for patients without events."}
Recruitment
- Registry Or Advocacy Recruitment
- True, European Hematology Association | Pohjois-Savon hyvinvointialue
- Planned Sample Size
- 306
- Recruitment Window Months
- 112
- Consent Approach
- Informed consent is obtained using age-appropriate subject information sheets and consent/assent forms. Parental/legal guardian consent is required for minors; assent forms and information sheets are provided for children/adolescents (separate documents for age bands such as under 8, 8-11, 12-17, 15-17). Adult participants provide their own consent. Multiple country-specific and language-specific ICFs are available (examples in English, French, Dutch, Italian, German, Spanish, Czech, Finnish, Swedish among others).
Geography
- Total Number Of Participants
- 306
Austria
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 29-10-2024
- Processing Time Days
- 18
- Number Of Participants
- 6
Belgium
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 25-10-2024
- Processing Time Days
- 14
- Number Of Participants
- 6
Czechia
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 30-10-2024
- Processing Time Days
- 19
- Number Of Participants
- 18
Denmark
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 27-10-2024
- Processing Time Days
- 16
- Number Of Participants
- 6
Finland
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 28-10-2024
- Processing Time Days
- 17
- Number Of Participants
- 6
France
- Earliest CTIS Part Ii Submission Date
- 29-10-2024
- Latest Decision Or Authorization Date
- 12-11-2024
- Processing Time Days
- 14
- Number Of Participants
- 66
Germany
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 25-10-2024
- Processing Time Days
- 14
- Number Of Participants
- 72
Italy
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 05-11-2024
- Processing Time Days
- 25
- Number Of Participants
- 48
Spain
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 25-10-2024
- Processing Time Days
- 14
- Number Of Participants
- 24
Sweden
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 25-10-2024
- Processing Time Days
- 14
- Number Of Participants
- 12
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 25-10-2024
- Processing Time Days
- 14
- Number Of Participants
- 18
Poland
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 28-10-2024
- Processing Time Days
- 17
- Number Of Participants
- 24
Sponsor
Primary sponsor
- Full Name
- Universita Degli Studi Di Milano Bicocca
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Italy
Third parties
- {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- IMATINIB
- Active Substance
- IMATINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Maximum Dose
- 800 mg
- Investigational Product Name
- TIOGUANINE
- Active Substance
- TIOGUANINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Maximum Dose
- 60 mg/m2
- Investigational Product Name
- DOXORUBICIN HYDROCHLORIDE
- Active Substance
- DOXORUBICIN HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Maximum Dose
- 25 mg/m2
- Investigational Product Name
- PEGASPARGASE
- Active Substance
- PEGASPARGASE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Maximum Dose
- 2500 m2
- Investigational Product Name
- CYTARABINE
- Active Substance
- CYTARABINE
- Modality
- Small molecule
- Routes Of Administration
- INTRATHECAL USE / INJECTION / SUSPENSION FOR INJECTION
- Route
- INTRATHECAL/INJECTION
- Maximum Dose
- 4000 mg/m2
- Investigational Product Name
- DEXAMETHASONE
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL AND IV
- Route
- ORAL AND IV
- Maximum Dose
- 20 mg/m2
- Investigational Product Name
- DELTACORTENE 25 mg compresse (PREDNISONE)
- Active Substance
- PREDNISONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL AND IV
- Route
- ORAL AND IV
- Authorisation Status
- 010089035
- Maximum Dose
- 60 mg/m2
- Investigational Product Name
- MERCAPTOPURINE
- Active Substance
- MERCAPTOPURINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Maximum Dose
- 75 mg/m2
- Investigational Product Name
- Erwinase 10 000 U (CRISANTASPASE)
- Active Substance
- CRISANTASPASE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- 050520016
- Maximum Dose
- 40000 IU
- Investigational Product Name
- DAUNORUBICIN HYDROCHLORIDE
- Active Substance
- DAUNORUBICIN HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Maximum Dose
- 30 mg/m2
- Investigational Product Name
- IFOSFAMIDE
- Active Substance
- IFOSFAMIDE
- Modality
- Small molecule
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Maximum Dose
- 1600 mg/m2
- Investigational Product Name
- METHOTREXATE
- Active Substance
- METHOTREXATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS, INTRA-ARTERIAL, INTRATHECAL, ORAL, INFUSION (varies by formulation)
- Route
- IV/IT/ORAL/INFUSION
- Maximum Dose
- 5000 mg or mg/m2 (formulation-dependent)
- Investigational Product Name
- CYCLOPHOSPHAMIDE
- Active Substance
- CYCLOPHOSPHAMIDE
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Maximum Dose
- 1 mg/m2
- Investigational Product Name
- ETOPOSIDE
- Active Substance
- ETOPOSIDE
- Modality
- Small molecule
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Maximum Dose
- 200 mg/m2
- Investigational Product Name
- Vincristina Teva Italia (VINCRISTINE SULFATE)
- Active Substance
- VINCRISTINE SULFATE
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- 038549010
- Maximum Dose
- 2 mg
- Investigational Product Name
- HYDROCORTISONE SODIUM SUCCINATE
- Active Substance
- HYDROCORTISONE SODIUM SUCCINATE
- Modality
- Small molecule
- Routes Of Administration
- INTRATHECAL USE / INJECTION/INFUSION
- Route
- INTRATHECAL/INJECTION/INFUSION
- Maximum Dose
- 12 mg
- Combination Treatment
- Yes
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