CHEMO-T: This phase II trial is comparing two types of chemotherapy (GEM-P and CHOP) for the treatment of T-Cell LymphomaCyclophosphamide, Doxorubicin, Vincristine and Prednisolone (CHOP) Versus Gemcitabine, Cisplatin and Methyl Prednisolone (GEM-P) in the First Line Treatment Of T-cell Lymphoma,a Multicentre Randomised Phase II Study

Inclusion

Previously untreated, histologically proven T-cell Lymphoma (any of the following):

• Peripheral T-cell lymphoma Not Otherwise Specified (PTCL NOS)
• Systemic Anaplastic large cell lymphoma (ALCL) ALK negative cases only
• Angioimmunoblastic T-cell lymphoma
• Hepatosplenic gamma/ delta T-cell lymphoma

• Enteropathy-associated T-cell lymphoma (EATL)

  • Bulky stage I not being considered for reduced chemotherapy plus involved field radiotherapy or stage II, III or IV.
  • Patient is male or female, and ≥18 years of age on the day of signing informed consent.
  • WHO performance status 0, 1 or 2.
  • Cross sectional imaging from a baseline contrast enhanced CT should show at least one measurable disease site that is at least 2 cm in longest diameter and measurable in two perpendicular dimensions with or without corresponding Fluorodeoxyglucose(FDG) avid lesions.
  • Adequate cardiac function; formal assessment of left ventricular ejection fraction is only required if clinically indicated (a baseline echocardiogram should be done for patients with either hypertension, age > 60 years or history of cardiac disease)
  • Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.0x109/l; white blood cell count ≥ 3x109/l; platelets ≥ 100x109/l; haemoglobin (Hb) ≥ 9g/dl (can be post-transfusion), unless deemed disease related
  • Adequate renal function: calculated creatinine clearance ≥50ml/minute.
  • Adequate liver function: serum bilirubin ≤1.5x Upper limit of normal (ULN); Alanine transaminase/Aspartate transaminase (ALT/AST) ≤2.5x ULN; ALP ≤3x ULN (in the absence of liver metastases). If liver metastases are present, ALT, AST or Alkaline phosphatase (ALP) ≤5x ULN are permitted. Isolated hyperbilirubinaemia due to Gilbert's disease is acceptable
  • Female patient of childbearing potential must have a negative serum or urine β-human chorionic gonadotropin(hCG)pregnancy test at baseline.
  • Written informed consent must be obtained prior to start of study treatments. Scans and bone marrow biopsies performed within 4 weeks of commencement of therapy will be acceptable provided they have been performed according to study requirements.
  • Patient agreeable to use contraception for the period of study treatment and up to 12 months after the last dose of study drugs.