2-CDA and Rituximab as Remission Induction and Rituximab as In Vivo Purging Prior to Peripheral Stem Cell Mobilization in Patients With Chronic Lymphocytic Leukemia (CLL) - A Prospective Multicenter Phase II Trial
- Determine the efficacy and tolerability of cladribine and rituximab as remission
induction therapy in patients with chronic lymphocytic leukemia.
- Determine the complete remission rate in patients treated with this regimen.
- Determine the very good partial remission rate and nodular partial remission rate in
patients treated with this regimen.
- Determine the toxicity of this regimen, in terms of hemotoxicity and infection rate, in
- Determine the efficacy of in vivo purging with rituximab measured by immunophenotyping
in these patients.
- Determine the feasibility of stem cell harvest in these patients after treatment with
this induction therapy regimen and in vivo purging with rituximab.
OUTLINE: This is a multicenter study.
- Remission induction: Patients receive cladribine subcutaneously (SC) on days 1-5.
During courses 2-4, patients also receive rituximab IV on day 1. Treatment repeats
every 28 days for up to 4 courses in the absence of unacceptable toxicity. If
unacceptable toxicity persists, patients receive rituximab alone.
Patients not achieving a complete remission (CR), very good partial remission (VGPR), or
nodular partial remission (NPR) receive CHOP chemotherapy comprising cyclophosphamide IV,
doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment
repeats every 21 days for up to 4 courses or until patients achieve a CR, VGPR, or NPR.
Patients achieving a CR, VGPR, or NPR proceed to stem cell mobilization and in vivo purging.
- Stem cell mobilization and in vivo purging: Beginning 8-10 weeks after the first day of
the last course of remission induction or CHOP, patients receive rituximab IV on days 1
and 8, cyclophosphamide IV over 4 hours on day 2, and filgrastim (G-CSF) SC daily
beginning on day 4 and continuing until the last day of apheresis. Patients undergo
apheresis on days 11-14.
PROJECTED ACCRUAL: A total of 17-41 patients will be accrued for this study within 3 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete-remission rate after induction
Reinhard Zenhaeusern, MD
University Hospital Inselspital, Berne