Chronic Lymphocytic Leukemia Clinical Trial
Official title:
CHOP Plus Rituximab (CHOP-R) in Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL) or CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,
such as rituximab, can block cancer growth in different ways. Some block the ability of
cancer cells to grow and spread. Others find cancer cells and help kill them or carry
cancer-killing substances to them. Giving more than one drug (combination chemotherapy)
together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
with rituximab works in treating patients with chronic lymphocytic leukemia (CLL) that has
not responded to fludarabine (closed to entry as of 10/2006), CLL with autoimmune hemolytic
anemia, or Richter transformation.
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.
;
Primary Purpose: Treatment
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