Clinical trial · Interventional
Chlorambucil in Treating Patients With Advanced Chronic Lymphocytic Leukemia
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chlorambucil | Drug | Chlorambucil | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 specifiedReferences
Publications (0)
Data not yet available