Chlorambucil in Treating Patients With Advanced Chronic Lymphocytic Leukemia
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia
Intervention: chlorambucil (Drug); cyclophosphamide (Drug); fludarabine phosphate (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: European Organization for Research and Treatment of Cancer Official(s) and/or principal investigator(s):
Branimir Jaksic, MD, PhD, Affiliation: University of Zagreb Medical School
Summary
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 chlorambucil regimen is more effective
in treating advanced chronic lymphocytic leukemia.
PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of
chlorambucil in treating patients who have advanced chronic lymphocytic leukemia.
Clinical Details
Official title: Low Dose Chlorambucil Maintenance Vs. No Treatment Following High-Dose Chlorambucil Induction In Patients With Advanced B-Chronic Lymphocytic Leukemia. A Randomized Phase III Study Of The EORTC LG (CLL-3)
Study design: Treatment, Randomized, Active Control
Detailed description:
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Cliniques Universitaires Saint-Luc, Brussels 1200, Belgium
Hopital de Jolimont, Haine Saint Paul 7100, Belgium
Hopital Universitaire Erasme, Brussels 1070, Belgium
University Hospital - Olomouc, Olomouc 775 20, Czech Republic
County Hospital, Kaposvar H-7400, Hungary
Azienda Ospedaliera Papardo, Messina, Italy
Ospedale Sant' Eugenio, Rome 00144, Italy
Clinical Center Skopje, Skopje 91000, Macedonia, The Former Yugoslav Republic of
Leiden University Medical Center, Leiden 2300 CA, Netherlands
Leyenburg Ziekenhuis, 's-Gravenhage 2545 CH, Netherlands
Onze Lieve Vrouwe Gasthuis, Amsterdam 1091 HA, Netherlands
University Medical Center Nijmegen, Nijmegen NL-6500 HB, Netherlands
Hospital Escolar San Joao, Porto 4200, Portugal
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2001
Last updated: May 23, 2008
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