Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With CLL

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as cladribine, use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining cladribine with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving cladribine and rituximab as remission induction therapy together with rituximab and stem cell mobilization in treating patients with chronic lymphocytic leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Cladribine; Cyclophosphamide; Doxorubicin; Lenograstim; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of B-cell chronic lymphocytic leukemia (CLL)

• CD5 positive and CD23 positive

• Binet stage B, C, or progressive A

• Newly diagnosed disease OR no more than 1 prior alkylating agent regimen (e.g., chlorambucil or cyclophosphamide with or without prednisone)

PATIENT CHARACTERISTICS:

Age

• 18 to 65

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• No autoimmune hemolytic anemia

• No immune thrombocytopenia

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 2.5 times ULN*

• AST and ALT no greater than 2.5 times ULN* NOTE: *Unless clearly related to CLL liver involvement

Renal

• Creatinine clearance greater than 50 mL/min

Cardiovascular

• Ejection fraction at least 50%

• No severe heart failure

• No unstable angina pectoris

• No significant arrhythmia requiring chronic treatment

• No myocardial infarction within the past 3 months

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 12 months after study participation

• HIV negative

• No active infection

• No positive Coombs' test

• No history of significant neurologic or psychiatric disorders, including psychotic disorders or dementia

• No seizure disorder

• No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix

• No prior allergic reaction or hypersensitivity to study drugs or attributed to compounds of similar chemical or biological composition to study drugs or other study agents

• No uncontrolled diabetes mellitus

• No gastric ulcers

• No active autoimmune disease

• No alcohol or drug abuse

• No other concurrent serious underlying medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• No prior purine analogs (e.g., cladribine or fludarabine)

Endocrine therapy

• Not specified

Radiotherapy

• No concurrent radiotherapy

Surgery

• Not specified

Other

• More than 30 days since prior clinical trial participation

• No other concurrent experimental drugs