Angioimmunoblastic T-cell lymphoma
Conditions
Interventions
Product Name: Fludarabine
Pharmaceutical Form: Tablet
INN or Proposed INN: Fludarabine
Concentration unit: mg/m2 milligram(s)/square meter
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a new diagnosis of angioimmunoblastic lymphoma and measurable (i.e. anatomically assessable) disease WHO/ECOG performance status of 0, 1, or 2 Age >18 years Negative pregnancy test if the patient is of childbearing potential (Women of child bearing potential must in addition be prepared to comply with the pregnancy testing schedule stipulatred by the risk management programme operated by the supplier of thalidomide) Prepared to comply with the contraceptive measures stipulated by the thalidomide risk management scheme operated by the suppplier of the Thalidomide Signed consent form 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior chemotherapy for AITL - however patients may have received a short course of steroids for rapid symptom control prior to enrolment Active second malignancy or other concomitant serious medical condition, in particular peripheral neuropathy Known seropositivity for HBV, HCV or HIV Breastt feeding Severe impairment of renal or liver function (defined as serum creatinine, bilirubin or alkaline phosphatase > 2.5 times the upper limit of normal).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the response rate of patients treated with FluCy (Fludarabine and cyclophosphamide) chemptherapy.; Primary end point(s): Response rate following FluCy chemotherapy Incremental response rate to thalidomide treatment Toxicity of FluCy and Thalidomide treatment Progression-free and overall survival ; Secondary Objective: Incremental anatomical and molecular response rate during treatment with Thalidomide Toxicity of treatment with FluCy followed by Thalidomide Progression-free and overall survival Detailed pathological description of the disease at presentation and at relapse Assessment of the number of circulating clonal T-cells at presentation and during Thalidomide treatment Screening for possible etiological viruses at presentation Evolution of EBV viral load during folllow-up | — |
Countries
United Kingdom
Outcome results
None listed