A PHASE II EVALUATION OF HIGH DOSE CHEMOTHERAPY AND AUTOLOGOUS STEM CELL TRANSPLANTATION FOR INTESTINAL AND OTHER DEFINED HISTOLOGICAL SUBTYPES OF AGGRESSIVE T-CELL LYMPHOMA - ATCL Trial

niversity College London0 sites22 target enrollmentNovember 25, 2005

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: 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
Sponsor: niversity College London
Enrollment: 22
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

November 25, 2005

End Date

November 14, 2014

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

niversity College London

•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

•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%