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

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ClinicalTrials.gov Identifier: NCT00072007
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief 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.


Condition or disease Intervention/treatment Phase
Leukemia Biological: filgrastim Biological: rituximab Drug: CHOP regimen Drug: cladribine Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2002
Actual Primary Completion Date : March 2003
Actual Study Completion Date : October 2010



Intervention Details:
  • Biological: filgrastim
    filgrastim
  • Biological: rituximab
    rituximab
  • Drug: CHOP regimen
    CHOP regimen
  • Drug: cladribine
    cladribine
  • Drug: cyclophosphamide
    cyclophosphamide
  • Drug: doxorubicin hydrochloride
    doxorubicin hydrochloride
  • Drug: prednisone
    prednisone
  • Drug: vincristine sulfate
    vincristine sulfate


Primary Outcome Measures :
  1. Complete-remission rate after induction [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Very good partial remission and nodular partial remission after induction [ Time Frame: 30 days ]
  2. Toxicity (hematotoxicity and infection rate) at 30 days following study treatment [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072007


Locations
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Switzerland
Kantonspital Aarau
Aarau, Switzerland, 5001
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, CH-6500
Inselspital Bern
Bern, Switzerland, CH-3010
Spitaeler Chur AG
Chur, Switzerland, CH-7000
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Kantonsspital, Luzerne
Luzerne, Switzerland, CH-6000
Hopital des Cadolles, Neuchatel
Neuchatel, Switzerland, 2000
Praxis Dr. Beretta
Rheinfelden, Switzerland, 4310
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Onkozentrum
Zurich, Switzerland, 8038
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
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Study Chair: Reinhard Zenhaeusern, MD University Hospital Inselspital, Berne

Publications of Results:
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Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00072007     History of Changes
Other Study ID Numbers: SAKK 34/02
EU-20321
First Posted: November 6, 2003    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Swiss Group for Clinical Cancer Research:
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

Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Liposomal doxorubicin
Vincristine
Cladribine
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors