ITCL - High dose

Trial overview

Phase II open label single arm study to assess the feasibility and efficacy of intensive chemotherapy followed by autologous stem cell transplantation in a cohort of patients with Intestinal T cell non-Hogkin's lymphoma. Patients will receive one cycle of CHOP followed by 3 courses of IVE alternating with intermediate dose methotrexate. Stem cells will be harvested after either the second or third cycle of IVE chemotherapy and patients achieving a complete remission will receive consolidation therapy with a myeloablative autologous stem cell transplant.

Inclusion criteria

Newly confirmed diagnosis of intestinal T cell lymphoma/ Enteropathy-type T-cell lymphoma according to WHO classification. (Usual phenotype CD3, CD7 positive, CD5, CD4, CD8 negative; often CD30 positive). May be entered even where complete surgical resection has occured.
Age greater than 18 years.
Patients must be physically able to tolerate the planned treatment programme. Patients who are not suitable for intensive treatment either through reasons of age or co-morbidity are encouraged to participate in the registration study so that outcomes for all groups of patients are recorded.
Patients must give written informed consent.
Diagnostic or emergency surgical procedures are permitted.

Exclusion criteria

Pregnancy or breast feeding.
Prior chemotherapy or radiotherapy for treatment of their lymphoma.
Patients with any serious concomitant medical or psychiatric condition that would preclude them tolerating the planned treatment should be entered into the registration study only.
Active malignancy or treatment for active malignancy in the last 5 years, excluding cervical intraepithelial neoplasia (CIN) or localised skin cancer.
Known seropositivity for HBV HCV or HIV.
Severe impairment of liver function (defined as bilirubin or alkaline phosphatase > 2.5 times the upper limit of normal ).
Severe impairment of renal function (measured creatinine clearance less than 50ml/min).
Abnormal bone marrow function (unsupported neutrophils <1.5x10⁹/l, platelets <100x10⁹/l) unless attributed to lymphomatous bone marrow infiltration.
Severe impairment of cardiac function. Either active uncontrolled cardiovascular disease or if there is a previous history of cardiac problems / abnormal ECG, a left ventricular ejection fraction less than 50%.