Angioimmunoblastic T-cell Lymphoma (AITL) MedDRA version: 20.0 Level: PT Classification code 10002449 Term: Angioimmunoblastic T-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Revlimid (lenalidomide)
Product Name: Lenalidomide
Pharmaceutical Form: Capsule
INN or Proposed INN: LENALIDOMIDE
CAS Number
Sponsors
LYSARC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with histologically proven T-cell angioimmunoblastic lymphoma (AITL) • Age from 60 to 80 years. • ECOG performance status 0 to 2. • No previous therapy (except corticosteroids providing they have been initiated less than 15 days before inclusion). • Spontaneous life expectancy > 1 month. • Written informed consent. The Lenalidomide Information Sheet (in appendix of the Patient Informed Consent Form) given to each patient receiving lenalidomide study therapy, must be read prior to starting treatment and at each new supply of study drug. • Male patients must: Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy. Agree to not give semen or sperm during study drug therapy and for a period after end of study drug therapy. • All patients must: Have an understanding that the study drug could have a potential teratogenicity. Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. Agree not to share study medication with another person. Be counselled about pregnancy precautions and risks of foetal exposure. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Other categories of T-cell lymphoma. • Central nervous system involvement by lymphoma. • Any previous therapy for lymphoma except short-term corticosteroids (maximum 10 days) before inclusion. • Contra-indication to any drug included in the CHOP regimen. • Serious medical or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator’s decision). • Active bacterial, viral or fungal infection, in particular active hepatitis B or C and HIV positive serological test. • Impaired renal function (Creatinine clearance 30 µmol/L, transaminases > 2.5 upper normal limits) unless they are related to the lymphoma. • Poor bone marrow reserve as defined by neutrophils < 1.0 x 109/L or platelets < 100 x 109/L, unless related to bone marrow infiltration. • Any history of cancer during the last 5 years, with the exception of non basal cell carcinoma of the skin or in situ carcinoma of the cervix. • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study. • Hypersensitivity to the active substance or to any of the excipients. • Pregnant and lactating woman • Females of Childbearing potential (FCBP*) according to the PPP (in appendix 18.13 of the protocol) *A FCBP isa female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Complete Metabolic Response (CMR) rate at the end of treatment defined according to Lugano Classification (Cheson et al, 2014, PET-CT-Based response) ; Secondary Objective: - Complete response (CR) rate at the end of treatment according to the IWC (International Harmonization Project – Cheson 2007,) as assessed by site Investigator. - Progression-free survival at 2 years (2y-PFS), events being relapse for complete responders, disease progression, and death from any cause. - Overall survival (OS) and event-free survival (EFS) - To evaluate the role of PET in defining an accurate staging - To evaluate the tumor metabolic activity based on FDG avidity measured by SUV max at baseline and the decrease of SUV max at the end of treatment - To correlate response rate, survival and biological factors (phenotype, EBV status, T/B clonality, circulating cytokine dosages). - An additional objective is to favour the banking of tumor cells suspensions (from lymph node biopsies, PB, effusions,…) ;Primary end point(s): The primary endpoint is the Complete Response (CR) rate at the end of treatment according to Cheson 2007 criteria and based on PET scan independent central review.;Timepoint(s) of evaluation of this end point: At the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Efficacy endpoints Secondary efficacy endpoints will include: * PROGRESSION-FREE SURVIVAL (PFS) Progression-Free Survival will be measured from the date of inclusion to the date of first documented disease progression, relapse or death from any cause, whichever occurs first. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date. * OVERALL SURVIVAL (OS) Overall survival will be measured from the date of inclusion to the date of death from any cause. Patients alive will be censored at their last follow-up date. Patients who are alive or lost to follow-up at the time of analysis will be censored at the date of the last contact. * EVENT-FREE SURVIVAL (EFS) Event-Free Survival will be measured from the date of inclusion to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date. - Safety endpoints All subjects who received at least one dose of Revlimid will be considered evaluable and analyzed for safety. Analysis of safety will be performed by summarizing adverse events, laboratory data, physical examination findings and vital signs. When applicable, summary of safety data will also be performed by cycle. - Exploratory analyses All other analyses (like subgroup analyses, role of PET scan, biological studies, prognostic factors) will be considered as exploratory analyses. ;Timepoint(s) of evaluation of this end point: At the end of treatment | — |
Countries
Belgium
Contacts
Public ContactProject Manager
LYSARC
Outcome results
None listed