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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
filgrastim
rituximab
CHOP regimen
cladribine
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kantonspital Aarau
  • Oncology Institute of Southern Switzerland
  • Inselspital Bern
  • Spitaeler Chur AG
  • Centre Hospitalier Universitaire Vaudois
  • Kantonsspital, Luzerne
  • Hopital des Cadolles, Neuchatel
  • Praxis Dr. Beretta
  • Kantonsspital - St. Gallen
  • Onkozentrum
  • UniversitaetsSpital Zuerich

Outcomes

Primary Outcome Measures

Complete-remission rate after induction

Secondary Outcome Measures

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

Full Information

First Posted
November 4, 2003
Last Updated
May 14, 2012
Sponsor
Swiss Group for Clinical Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00072007
Brief Title
Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With CLL
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 Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Description
filgrastim
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Description
rituximab
Intervention Type
Drug
Intervention Name(s)
CHOP regimen
Intervention Description
CHOP regimen
Intervention Type
Drug
Intervention Name(s)
cladribine
Intervention Description
cladribine
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Description
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Description
vincristine sulfate
Primary Outcome Measure Information:
Title
Complete-remission rate after induction
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Very good partial remission and nodular partial remission after induction
Time Frame
30 days
Title
Toxicity (hematotoxicity and infection rate) at 30 days following study treatment
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinhard Zenhaeusern, MD
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Oncology Institute of Southern Switzerland
City
Bellinzona
ZIP/Postal Code
CH-6500
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Spitaeler Chur AG
City
Chur
ZIP/Postal Code
CH-7000
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Kantonsspital, Luzerne
City
Luzerne
ZIP/Postal Code
CH-6000
Country
Switzerland
Facility Name
Hopital des Cadolles, Neuchatel
City
Neuchatel
ZIP/Postal Code
2000
Country
Switzerland
Facility Name
Praxis Dr. Beretta
City
Rheinfelden
ZIP/Postal Code
4310
Country
Switzerland
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Onkozentrum
City
Zurich
ZIP/Postal Code
8038
Country
Switzerland
Facility Name
UniversitaetsSpital Zuerich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20218808
Citation
Leupin N, Schuller JC, Solenthaler M, Heim D, Rovo A, Beretta K, Gregor M, Bargetzi MJ, Brauchli P, Himmelmann A, Hanselmann S, Zenhausern R. Efficacy of rituximab and cladribine in patients with chronic lymphocytic leukemia and feasibility of stem cell mobilization: a prospective multicenter phase II trial (protocol SAKK 34/02). Leuk Lymphoma. 2010 Apr;51(4):613-9. doi: 10.3109/10428191003624231.
Results Reference
result
Citation
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.
Results Reference
result

Learn more about this trial

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

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