Phase ll Trial of Fludarabine & Cyclophosphamide followed by Thalidomide for Angioimmunoblastic Lymphoma - AIT
- Conditions
- Angioimmunoblastic T-cell lymphoma
- Registration Number
- EUCTR2005-003931-40-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
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
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method