Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients Wit… (NCT03593018) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory AITL
Austria, Belgium86 participantsStarted 2018-11-09
Plain-language summary
This study evaluates the efficacy of Oral azacitidine versus single-agent Investigator's Choice Therapy in patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
✓. Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted.
✓. Patient is willing and able to adhere to the study visit schedule and other protocol requirements
✓. Patient had local diagnosed peripheral T cell lymphoma (PTCL) with T-follicular helper (TFH) phenotype according to the criteria of the latest World Health Organization (WHO) classification based on a surgical lymph node biopsy including any one of
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
✓. Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below.)
✓. Meet the following lab criteria:
✓. Anticipated life expectancy at least 3 months
Exclusion criteria
✕. Clinical evidence of central nervous system involvement by lymphoma. Patients with suspicion of central nervous system (CNS) involvement must undergo neurologic evaluation and CT/MRI of head and lumbar puncture to exclude CNS disease.
✕. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision)
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: 18 months after first randomisation (when 18 events will occur)
2
Progression Free Survival (PFS)
Timeframe: 35 months after first randomisation (when 61 events will occur)
Trial details
NCT IDNCT03593018
SponsorThe Lymphoma Academic Research Organisation
✕. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment)
✕. Known Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) infection, or evidence of positive HTLV1 serology or of active Hepatitis B (HB) Virus (HBV) infection defined as:
✕. Impaired renal function (MDRD formula or Cockcroft-Gault Creatinine Clearance \< 30 ml/min) or impaired liver function tests (Serum total bilirubin level \> 2.0 mg/dl \[34 µmol/L\] (except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma), Serum transaminases (AST or ALT) \> 3 upper normal limits) unless they are related to the lymphoma.
✕. Active malignancy other than the one treated in this research. Prior history of malignancies, other than low risk MDS or chronic myelomonocytic leukemia (CMML) (with less than 5% blasts in bone marrow), unless the patient has been free of the disease for ≥ 3 years. However, patients with the following history/concurrent conditions are allowed: