Defined histological subtypes of aggressive T-Cell Lymphoma: - Intestinal T-cell / Enteropathy-type T-Cell lymphoma (ETL) - Peripheral T-cell lymphoma NOS - Hepatosplenic T-cell lymphoma - ALK negative Anaplastic T-Cell Lymphoma - Extranodal NK/T-cell lymphoma MedDRA version: 20.0 Level: LLT Classification code 10034624 Term: Peripheral T-cell lym
Conditions
Interventions
Product Name: Cyclophosphamide
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cyclophosphamide
CAS Number: 50-18-0
Conc
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Newly confirmed diagnosis of intestinal T-cell/Enteropathy-type T-Cell lymphoma, Peripheral T-cell lymphoma (NOS), Hepatosplenic T-cell lymphoma, ALK negative Anaplastic T-cell lymphoma and Extranodal NK/T-cell lymphoma according to the WHO classification. Patients with ETL may be entered even where complete surgical resection has occurred. 2. Age greater than 18 years. 3. Patients must be physically able to tolerate the planned treatment programme. Patients with ETL 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. 4. Patients must give written informed consent 5. Diagnostic or emergency surgical procedures are permitted 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: 1. Pregnancy or breastfeeding 2. Prior chemotherapy or radiotherapy for treatment of their lymphoma. 3. ETL 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. 4. Active malignancy or treatment for malignancy in the last 5 years, excluding cervical intraepithelial neoplasia (CIN) or localised skin cancer 5. Known seropositivity for HBV HCV or HIV 6. Severe impairment of liver function (defined as bilirubin or alkaline phosphatase > 2.5 times the upper limit of normal). 7. Severe impairment of renal function (measured creatinine clearance less than 50 ml/min) 8. Abnormal bone marrow function (unsupported neutrophils < 1.5x109/l, platelets < 100x109/l) unless attributed to lymphomatous bone marrow infiltration 9. 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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess one year survival after high dose chemotherapy and autologous transplantation;Primary end point(s): Survival at one year;Timepoint(s) of evaluation of this end point: 1 year post registration; Secondary Objective: - To assess the toxicity of the regimen in a large population of patients - To provide a co-ordinated approach to the treatment of these patients. - To register patients with ETL unfit for the protocol chemotherapy into the pathological part of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Toxicity;Timepoint(s) of evaluation of this end point: At the end of each treatment cycle and end of transplant | — |
Countries
United Kingdom
Contacts
Public ContactITCL Trial Coordinator
Cancer Research UK & UCL Cancer Trials Centre
Outcome results
None listed