Angioimmunoblastic Tcell Lymphoma

Trial overview

Phase ll Trial of Fludarabine & Cyclophosphamide followed by Thalidomide for Angioimmunoblastic Lymphoma

Inclusion criteria

• Patients with a new diagnosis of angioimmunoblastic lymphoma and measurable (ie anatomically assessable) disease

• WHO/ECOG performance status of 0, 1 or 2

WHO/ECOG Performance Scale:
0 - Able to carry out normal activities without restriction.
1 - Restricted in physically strenuous activity, but ambulatory and able to carry out light work
2 - Ambulatory and able to self-care, but unable to carry out any work; up and about more than 50% of waking hours.
3 - Capable of only limited self-care; confined to bed or chair for more than 50% of waking hours.
4 - Completely disabled; cannot carry out any self-care; totally confined to bed or chair.

• 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 stipulated by the risk management programme operated by the NHS site where they are receiving treatment).

• Prepared to comply with the contraceptive measures stipulated by the Thalidomide Risk Management Programme organised by the NHS site that is treating the patient (Please see the Protocol Appendix 7 for further details)

• Signed consent form.

Exclusion criteria

• Prior chemotherapy for AITL (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

• Breast feeding

• Severe impairment of renal or liver function (defined as serum creatinine, bilirubin or alkaline phosphatase > 2.5 times the upper limit of normal).