Completed

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

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What is being tested

Data Collection

Who is being recruted

Chronic Disease
+11

+ Hematologic Diseases
+ Immune System Diseases
From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2002
See protocol details

Summary

Principal SponsorSwiss Group for Clinical Cancer Research
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2002Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * 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. Secondary * 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.

Official Title2-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 
NCT00072007
Principal SponsorSwiss Group for Clinical Cancer Research
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
43 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Chronic Disease
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Disease Attributes
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 11 locations
Suspended
Kantonspital AarauAarau, SwitzerlandSee the location
Suspended
Oncology Institute of Southern SwitzerlandBellinzona, Switzerland
Suspended
Inselspital BernBern, Switzerland
Suspended
Spitaeler Chur AGChur, Switzerland
Completed11 Study Centers
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