Overview

Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia (CLL) That Did Not Respond to Fludarabine, CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT)

Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
German CLL Study Group
Treatments:
Cyclophosphamide
Doxorubicin
Fludarabine
Fludarabine phosphate
Liposomal doxorubicin
Prednisone
Rituximab
Vincristine
Criteria
DISEASE CHARACTERISTICS:

- Confirmed diagnosis of previously treated chronic lymphocytic leukemia (CLL) meeting
the following criteria:

- Binet stage B (Rai stages I and II) or Binet stage C (Rai stages III and IV)
disease

- Rapid disease progression, symptomatic enlarged lymph nodes, or severe B-cell
symptoms

- CLL with autoimmune hemolytic anemia allowed

- Richter transformation allowed

PATIENT CHARACTERISTICS:

- Life expectancy > 3 months

- ECOG performance status 0-3

- No severe organ dysfunction

- No other prior or concurrent neoplasms

PRIOR CONCURRENT THERAPY:

- No more than 4 prior chemotherapy regimens