Angioimmunoblastic T cell Lymphoma MedDRA version: 21.0 Level: PT Classification code 10002452 Term: Angioimmunoblastic T-cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10002453 Term: Angioimmunoblastic T-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: oral azacitidine
Product Code: CC-486
Pharmaceutical Form: Tablet
INN or Proposed INN: oral azacitidine
CAS Number: 320-67-2
Current Sponsor code: CC-486
Concentration unit: mg milligram
Sponsors
LYSARC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - = 18 years - local diagnosed peripheral T cell lymphoma (PTCL) with T-follicular helper (TFH) phenotype according to the criteria of the latest WHO classification based on a surgical lymph node biopsy including any one of • Angioimmunoblastic T cell lymphoma (AITL) • Follicular T cell lymphoma • Nodal peripheral T-cell lymphoma with TFH phenotype with a documented expression of minimum two TFH markers among CD10, CXCL13, PD1, ICOS and BCL6 - ECOG performance status 0 to 3 - Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy - Meet the following lab criteria: • ANC = 1,5 x 109/L (= 1 x 109/L if BM involvement by lymphoma) • Platelet = 75 x 109/L (= 50 x 109/L if BM involvement by lymphoma) • Hemoglobin = 8 g/dL. - Anticipated life expectancy at least 3 months - At least one measurable lesion on CT greater than 1.5 cm in the longest diameter for nodal lesions and than 1.0 cm in the longest diameter for extranodal lesions. - Female patient of childbearing potential (FCBP) with two negative pregnancy tests : serum pregnancy test at Screening and negative serum or urine pregnancy test within 72 hours prior to starting treatment with study treatment, who agrees to practice true abstinence or to use highly effective methods of contraception and who agrees to abstain from breastfeeding - Male patient who agrees to practice true abstinence from heterosexual contact or to use highly effective methods of contraception and who agrees not to give semen or sperm Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 37 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 49
Exclusion criteria
Exclusion criteria: - Clinical evidence of central nervous system involvement by lymphoma. - Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study - Uncontrolled systemic fungal, bacterial, or viral infection - Known Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) infection, or evidence of active Hepatitis B Virus (HBV) infection defined as: - HBs Ag positive - HBs Ag negative, anti-HBs antibody positive and/or anti-HBc antibody positive with detectable viral DNA - Impaired renal function (calculated MDRD or Cockcroft-Gault Creatinine Clearance 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, except a. Basal or squamous cell carcinoma of the skin b. Carcinoma in situ of the cervix c. Carcinoma in situ of the breast d. Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor, nodes, metastasis [TNM] clinical staging system e. Early-stage gastric cancer suitable for endoscopic mucosal resection or endoscopic submucosal dissection - Treatment with any investigational drug within 5 half-lives before planned first cycle of study treatment and during the study. - Prior exposure to azacitidine and/ or any other demethylating agent (eg, decitabine) - Prior exposure to planned study treatment investigator’s choice therapy - Concurrent use of corticosteroids unless the patient is on a stable or decreasing dose for = 1 week prior to informed consent form signature - Known or suspected hypersensitivity to active substance or to any of the excipients. - Pregnant, planning to become pregnant, or lactating woman - Candidate for hematopoietic stem cell transplantation - History of active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the oral azacitidine and/or predispose the patient to an increased risk of gastrointestinal toxicity per investigator’s decision. Any condition causing inability to swallow tablets. - Significant active cardiac disease within the previous 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - Overall Survival (OS) - PFS by the Independent Review Committee (IRC) - Overall response rate (ORR) - Complete response rate (CRR) - Duration of response - Time to response - PFS2 using local assessment of progressive disease - HRQOL endpoints EORTC QLQ-C30 - Safety ;Main Objective: Progression free survival (PFS), using local assessment of progressive disease according to Lugano Response Criteria (2014).;Primary end point(s): Progression free survival (PFS), using local assessment of progressive disease according to Lugano Response Criteria (2014).;Timepoint(s) of evaluation of this end point: end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: end of study;Secondary end point(s): - Overall Survival (OS) - PFS by the Independent Review Committee (IRC) - Overall response rate (ORR) - Complete response rate (CRR) - Duration of response - Time to response - PFS2 using local assessment of progressive disease - HRQOL endpoints EORTC QLQ-C30 - Safety | — |
Countries
Austria, Belgium, Denmark, Finland, France, Italy, Japan, Korea, Republic of, Sweden, United Kingdom
Contacts
Public ContactRegulatory Affairs
LYSARC
Outcome results
None listed