Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 to 65	Other	SWS-SAKK-34/02 EU-20321, NCT00072007

Objectives

Primary

1. Determine the efficacy and tolerability of cladribine and rituximab as remission induction therapy in patients with chronic lymphocytic leukemia.
2. Determine the complete remission rate in patients treated with this regimen.

Secondary

1. Determine the very good partial remission rate and nodular partial remission rate in patients treated with this regimen.
2. Determine the toxicity of this regimen, in terms of hemotoxicity and infection rate, in these patients.
3. Determine the efficacy of in vivo purging with rituximab measured by immunophenotyping in these patients.
4. Determine the feasibility of stem cell harvest in these patients after treatment with this induction therapy regimen and in vivo purging with rituximab.

Entry 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)

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

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

Expected Enrollment

A total of 17-41 patients will be accrued for this study within 3 years.

Outcomes

Complete-remission rate after induction

Very good partial remission and nodular partial remission after induction
Toxicity (hematotoxicity and infection rate) at 30 days following study treatment

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.

Leupin N, Schuller JC, Solenthaler M, et al.: The combination of 2-CDA and rituximab in patients with chronic lymphocytic leukemia (CLL): a prospective multicenter phase II trial (SAKK 34/02). [Abstract] Blood 110 (11): A-2057, 2007.

Trial Contact Information

Trial Lead Organizations

Swiss Group for Clinical Cancer Research

Reinhard Zenhaeusern, MD, Protocol chair		Ph: 41-31-632-4114

Registry Information
Official Title		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
Trial Start Date		2002-06-27
Registered in ClinicalTrials.gov		NCT00072007
Date Submitted to PDQ		2003-09-12
Information Last Verified		2006-05-02

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