METHOTREXATE for Burkitt lymphoma

Inclusion criteria

• {"criterion_text":"- First diagnosis of high risk Burkitt lymphoma (sporadic and HIV associated), histologically confirmed according to the WHO classification 2008. Upon its availability the WHO 2016 classification should be used, to replace the WHO 2008 classification\n- High risk disease; i.e. any of following: elevated LDH, WHO performance status ≥ 2 (appendix C), Ann Arbor stage III or IV (Appendix A), tumour mass ≥ 10 cm\n- Age 18-75 years inclusive\n- WHO performance status (PS) 0-3, WHO PS 4 only if disease related (Appendix C)\n- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- All histopathological diagnoses other than Burkitt lymphoma according to the WHO classification 2008, irrespective of the presence of a MYC rearrangement; Upon its availability the WHO 2016 classification should be used, to replace the WHO 2008 classification\n- Severe neurological or psychiatric disease\n- Active symptomatic ischemic heart disease, myocardial infarction, or congestive heart failure within the past year. If an ultrasound or MUGA scan is obtained the LVEF should exceed 45%\n- All men and all women of child-bearing potential not willing or able to use an acceptable method of birth control for the duration of the study and one year beyond treatment completion\n- Female subject pregnant or breast-feeding\n- History of a prior invasive malignancy in the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma\n- Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety, includig active hepatitis B (HBV, see also paragraph 9.3) or hepatitis C (HCV) infection\n- Current participation in another clinical trial interfering with HO127\n- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n- Patients with endemic Burkitt lymphoma\n- Patients with low risk Burkitt lymphoma (i.e. all of following: normal LDH, WHO performance status 0 or 1 (appendix C), Ann Arbor stage I or II (Appendix A), no tumour mass ≥ 10 cm)\n- Patients with CNS localization of Burkitt lymphoma\n- Prior treatment other than local radiation (max. 10 Gy) or short course (max 7 days) of steroids ≤ 1 mg/kg or ≤100mg predniso(lo)ne (whichever is greater; or equivalent corticosteroid) or acute symptoms; or 1 cycle of R-CHOP\n- Creatinine clearance < 50 ml/min unless lymphoma related\n- Inadequate hepatic function: bilirubin > 2.5 * ULN (total) except patients with Gilbert's syndrome as defined by > 80% unconjugated\n- Inadequate haematological function ANC < 1x10^9/l and platelets < 75x10^9 /l unless lymphoma related\n- Severe pulmonary dysfunction (CTCAE grade 3-4, see Appendix D)"}

Primary endpoints

• {"endpoint_text":"- 2-year PFS; defined as time from randomisation to disease progression, relapse or death, whichever comes first. Patients still alive or lost to follow up are censored at the date they were last known to be alive","definition_or_measurement_approach":"Defined as time from randomisation to disease progression, relapse or death, whichever comes first. Patients still alive or lost to follow up are censored at the date they were last known to be alive"}

Secondary endpoints

• {"endpoint_text":"- ORR end-of-treatment","definition_or_measurement_approach":""}
• {"endpoint_text":"- EFS at 2 years; defined as time from randomisation to first event (death from any cause, no CR, relapse, whichever comes first).","definition_or_measurement_approach":"Defined as time from randomisation to first event (death from any cause, no CR, relapse, whichever comes first)."}
• {"endpoint_text":"- OS at 2 years; defined as time from randomisation until death from any cause; patients still alive or lost to follow up are censored at the date they were last known to be alive","definition_or_measurement_approach":"Defined as time from randomisation until death from any cause; patients still alive or lost to follow up are censored at the date they were last known to be alive"}
• {"endpoint_text":"- Rate of CTCAE grade ≥3 toxicities","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of hospitalization days","definition_or_measurement_approach":""}

Belgium

Earliest CTIS Part Ii Submission Date

30-08-2024

Latest Decision Or Authorization Date

16-09-2024

Processing Time Days

17

Number Of Sites

3

Number Of Participants

10

Netherlands

Earliest CTIS Part Ii Submission Date

30-08-2024

Latest Decision Or Authorization Date

11-09-2024

Processing Time Days

12

Number Of Sites

9

Number Of Participants

59

Primary sponsor

Full Name

Haemato Oncology Foundation For Adults Netherlands

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"Netherlands","full_name":"Amsterdam UMC Stichting","duties_or_roles":"Pathology review","organisation_type":"Hospital/Clinic/Other health care facility"}