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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

Phase 2
18 Years
65 Years
Not Enrolling

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Trial Information

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
these patients.

- 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.

Inclusion Criteria


- 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)



- 18 to 65

Performance status

- WHO 0-2

Life expectancy

- Not specified


- No autoimmune hemolytic anemia

- No immune thrombocytopenia


- 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


- Creatinine clearance greater than 50 mL/min


- 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


- 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

- 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


Biologic therapy

- Not specified


- See Disease Characteristics

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

Endocrine therapy

- Not specified


- No concurrent radiotherapy


- Not specified


- More than 30 days since prior clinical trial participation

- No other concurrent experimental drugs

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete-remission rate after induction

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

Reinhard Zenhaeusern, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Inselspital, Berne


Switzerland: Swissmedic

Study ID:

SAKK 34/02



Start Date:

June 2002

Completion Date:

October 2010

Related Keywords:

  • Leukemia
  • B-cell chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid