Clinical trial · Interventional
Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV
- 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)
Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to its unique mechanism of action distinct from standard alkylating agents. This study assesses its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in comparison to fludarabine. Patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine 100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of 25 mg/m² on days 1 to 5 every four weeks. The primary objective was to achieve non-inferior progression-free survival with bendamustine.
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bendamustine | Drug | Bendamustine | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bendamustine
- interventionNames
- Drug: bendamustine
- type
- ACTIVE_COMPARATOR
- label
- Fludarabine
- interventionNames
- Drug: Fludarabine
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- the patients were followed on average for 36 months
- description
- individual time-frame up to max. follow-up (Kaplan-Meier estimation)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or immunologically confirmed chronic B-cell leukemia * refractory (i.e. no response or progression during initial chemotherapy) or relapsed situation after first-line treatment regimen * disease stage II-IV according to Rai or B/C according to Binet staging system, respectively * Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better * negative pregnancy test/ adequate method of contraception Exclusion Criteria: * T-CLL, PLL (prolymphocytic leukemia) * presence of Richter's transformation * first-line treatment containing either fludarabine or bendamustine * acute infections or distinctly reduced organ function precluding the application of chemotherapy, as for pulmonary, heart, liver (total bilirubin \> 5mg/dl), renal system (creatinine \> 2 mg/dl), or metabolic disorders * secondary malignancy (except for curative treated basal cell carcinoma or cervical cancer)
References
Publications (0)
Data not yet available