Trial Information

CHOP Plus Rituximab (CHOP-R) in Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL) or CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT)

OBJECTIVES:

Primary

- Determine the efficacy, in terms of the rate and quality of remission, of chemotherapy
comprising cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and
rituximab (CHOP-R) in patients with fludarabine-refractory chronic lymphocytic leukemia
(CLL) (closed to accrual as of 10/2006), CLL with autoimmune hemolytic anemia, or
Richter transformation.

- Determine the incidence of infection in patients on CHOP-R regimen.

Secondary

- Determine the toxicity of this regimen in these patients

- Determine the progression-free and overall survival of patients treated with this
regimen.

OUTLINE: This is a prospective, multicenter study. Patients are stratified according to
disease (chronic lymphocytic leukemia (CLL) (closed to accrual as of 10/2006) vs CLL with
autoimmune hemolytic anemia vs Richter transformation).

Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on
day 1 and oral prednisone on days 1-5. Patients also receive rituximab IV on day 1 of the
second course and each subsequent course. Treatment repeats every 21 days for up to 6 (for
patients with CLL) or 8 (for patients with Richter's transformation) courses in the absence
of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.