Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT03666559
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Glioma grade II or III with IDH1 or IDH2 mutation
* Recurring after standard treatment, ie radiotherapy and at least one alkylating chemotherapy, or alkylating chemotherapy alone in case of gliomatosis cerebri
* For the patients treated by radiotherapy, recurrence occurring more than three months from the end of the radiotherapy or occurring outside the irradiated volume
* Karnofsky Performance Status \> 50
* Life expectancy \> 9 months
* Suitable laboratory values obtained ≤ 7 days before inclusion visit:
* Absolute neutrophil count (ANC) ≥ 1500 /mm3
* Leucocytes ≥ 3,0 x 109/L
* Platelet count ≥ 75 000 / mm3
* Hemoglobin \> 9.0 g/dL
* Serum GlutamoOxaloacetate Transferase (SGOT) (AST) ≤ 3 x Upper Limit of Normal (ULN)
* Serum Glutamate Pyruvate Transaminase (SGPT) (ALT) ≤ 3 x ULN
* Creatininemia ≤ 1.5 x ULN
* Bicarbonates ≥ 22 mmol/l
* Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must :
* Have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study.
* Agree to use, and to be able to comply with, effective contraception without interruption, throughout the entire duration study drug therapy (including doses interruptions) and for 3 months after the end of the study drug therapy.
* Male patients :
* must agree to use a condom if engaged in sexual activity with a woman of childbearing potential during the entire period of treatment and during 3 months after end of treatment.
* are informed about the procedures for preservation of sperm before starting treatment.
* Written informed consent dated and signed, prior to any study specific procedures (sampling, treatment and analyses).
* Affiliation to the French health insurance (recipient or assign)
Exclusion Criteria:
* Breast-feeding women
* Any evidence of severe or uncontrolled systemic diseases (as judged by the investigator), including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) (Screening for chronic conditions is not required)
* Active pulmonary disease or congestive cardiac insufficiency
* Malignant hepatic tumor at a later stage
* Intracranial hypertension or important deviation of the midline on the MRI
* Any investigational agents or study drugs from a previous clinical study (within 30 days before the first dose of study treatment
* Any chemotherapy, anticancer immunotherapy or anticancer agents within 4 weeks (6 weeks for nitrosourea) before the first dose of study treatment
* Any unresolved toxicities (excepted alopecia and lymphopenia), from prior therapy greater than CTCAE grade 1 at the time of inclusion
* Known hypersensitivity to Azacitidine or Mannitol (E421), (refer to the Investigator's Brochure)
* Patients under curatorship or guardianship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03666559
Study Brief:
Protocol Section:
NCT03666559