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Home > "C" Clinical Trials Conditions > Chlorambucil in Treating Patients With Advanced Chronic Lymphocytic Leukemia  Chlorambucil in Treating Patients With Advanced Chronic Lymphocytic Leukemia
Chlorambucil in Treating Patients With Advanced Chronic Lymphocytic Leukemia
For Condition: B-cell Chronic Lymphocytic Leukemia,stage 3 chronic lymphocytic leukemia,stage 4 chronic lymphocytic leukemia
Status: Recruiting
Sponsor(s): EORTC Leukemia Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which chlorambucilregimen is more effective in treating advanced chronic lymphocytic leukemia. PURPOSE: Randomizedphase III trial to determine the effectiveness of different regimens of chlorambucil in treating patients who have advanced chronic lymphocytic leukemia.
Details: OBJECTIVES: - Compare overall and disease-related survival of patients with B-cell chronic lymphocytic leukemia treated with high-dose chlorambucil induction therapy with or without low-dose chlorambucil maintenance therapy. - Compare the time to salvage treatment in these patients treated with these regimens. - Compare the toxic effects of these regimens in these patients. - Compare the treatment-related mortality of these patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, time to complete response (before 12 weeks vs after 12 weeks vs partial response), and cytopenia at diagnosis (Binet stage A+B vs C). All patients receive induction therapy comprising high-dose oral chlorambucil daily. Treatment continues until achievement of complete response or a maximum of 24 weeks in the absence of disease progression or unacceptable toxicity. Patients who respond to induction therapy are randomized to 1 of 2 treatment arms for maintenance therapy. - Arm I: Patients receive low-dose oral chlorambucil twice a week. Therapy continues for up to 5 years in the absence of disease progression or unacceptable toxicity. If disease progression occurs, then patients may proceed to salvage therapy. - Arm II: Patients receive no maintenance therapy. If disease progresses, patients receive induction therapy again. If disease does not respond to re-induction therapy, then patients may proceed to salvage therapy. - Salvage therapy: Patients with progressive disease during maintenance therapy receive fludarabine IV daily and cyclophosphamide IV daily on days 1-3. Treatment repeats every 4 weeks for 3-6 courses. Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter. PROJECTED ACCRUAL: Approximately 470 patients will be accrued for this study within 4.7 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of B-cell chronic lymphocytic leukemia - Co-expression of CD5/CD19 or CD5/CD20 positivity, dim sIg, and CD23 positivity - Previously untreated advanced disease defined as presence of at least 1 of the following: - Total tumor mass (TTM) score greater than 9 - TTM doubling time less than 12 months - Bone marrow failure (platelet count less than 100,000/mm^3 and/or hemoglobin less than 10 g/dL) PATIENT CHARACTERISTICS: Age: - 18 to 75 Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin less than 3 times upper limit of normal (ULN) - Hepatitis B negative - No active hepatitis C Renal: - Creatinine less than 3 times ULN OR - Creatinine clearance greater than 0.5 times normal Cardiovascular: - No severe cardiovascular disease - No arrhythmia requiring chronic treatment - No New York Heart Association class III or IV congestive heart failure - No symptomatic ischemic heart disease Other: - No uncontrolled systemic infection - HIV negative - No prior or concurrent uncontrolled malignancy - No prior or concurrent central nervous system or psychiatric disorders requiring hospitalization - No psychological, familial, sociological, or geographical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy Chemotherapy: - No prior chemotherapy Endocrine therapy: - Prior steroid therapy for less than 2 weeks allowed Radiotherapy: - No prior radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BranimirJaksic, , University of Zagreb Medical School
University Hospital - Olomouc *Recruiting*
Olomouc, , 775 20
Czech Republic
Recruiting Contact Person 420-68-414-102
Ospedale Sant' Eugenio *Recruiting*
Rome, , 00144
Italy
Recruiting Contact Person 39-06-591474
County Hospital *Recruiting*
Kaposvar, , H-7400
Hungary
Recruiting Contact Person 36-82-411-535
Onze Lieve Vrouwe Gasthuis *Recruiting*
Amsterdam, , 1091 HA
Netherlands
Recruiting Contact Person 31-599-9111
Hopital de Jolimont *Recruiting*
Haine-Saint-Paul, , 7100
Belgium
Recruiting Contact Person 32-233-011
Leyenburg Ziekenhuis *Recruiting*
's-Gravenhage, , 2545 CH
Netherlands
Recruiting Contact Person 31-359-2653
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting Contact Person 31-361-1111
Hospital Escolar San Joao *Recruiting*
Porto, , 4200
Portugal
Recruiting Contact Person 351-502-7151
Cliniques Universitaires Saint-Luc *Recruiting*
Brussels, , 1200
Belgium
Recruiting Contact Person 32-764-1111
Clinical Center Skopje *Recruiting*
Skopje, , 91000
Macedonia, The Former Yugoslav Republic of
Recruiting Contact Person 389-11- 1749
Azienda Ospedaliera Papardo *Recruiting*
Messina, ,
Italy
Recruiting Contact Person 39-90-399-2855
Hopital Universitaire Erasme *Recruiting*
Brussels, , 1070
Belgium
Recruiting Contact Person 32-555-3111
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Contact Person 31-526-911
Additional Information:
Study ID Numbers: CDR0000068650; EORTC-06992-CLL-3
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017108
Other B-Cell Chronic Lymphocytic Leukemia Studies:
1. Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
2. Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia
3. Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia
4. Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia
5. Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Related Studies:
Other B-cell Chronic Lymphocytic Leukemia Clinical Trials
Other Clinical Trials
Other Brussels Clinical Trials
Chlorambucil in Treating Patients With Advanced Chronic Lymphocytic Leukemia
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