Clinical trial · Observational
A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia
A Post-Marketing Surveillance Study on the Safety And Effectiveness of Bendamustine Hydrochloride Among Adult Filipino Patients With Chronic Lymphocytic Leukemia
NCT01739491CI-TRIAL-00020011withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study is cancelled. FDA Circular 2013-004 mandates that PMSs like this are not required
Summary
Brief summary (as posted)
The purpose of this study is to assess safety and effectiveness of extended bendamustine in the treatment of chronic lymphocytic leukemia (CLL).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Bendamustine hydrochloride
- description
- Adult Filipino patients with chronic lymphocytic leukemia will be taking bendamustine hydrochloride as per the dosing regimen given on product insert approved in Philippines.
- interventionNames
- Drug: No intervention
Primary outcomes (2)
- measure
- Number of patients with incidence of adverse events
- timeFrame
- Up to Week 24
- measure
- Number of patients with incidence of discontinuation of study medication due to adverse events
- timeFrame
- Up to Week 24
Secondary outcomes (5)
- measure
- Number of patients who show complete remission
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult Filipino patients with chronic lymphocytic leukemia * Patients who are cytologically-diagnosed with chronic lymphocytic leukaemia (symptomatic Binet stage B or C) and for whom fludarabine combination chemotherapy is not appropriate * World health organization performance Status of 0, 1, or 2 * Need-to-treat criteria in B-cell chronic lymphocytic leukemia Exclusion Criteria: * Had received previous treatment with other cytotoxic drugs * Had a history of a second malignancy (except cured basal cell carcinoma or cured cervical cancer) * Concomitant illnesses such as overt heart failure, cardiomyopathy, myocardial infarction within the last 6 months, severe uncontrolled diabetes mellitus, severe uncontrolled hypertension, active infection that required systemic antibiotic treatment in an investigational drug study within 30 days prior to selection * Patients with severe renal and hepatic impairment * Patients with severe bone marrow suppression and severe blood count alterations * Pregnant women and lactating mothers
References
Publications (0)
Data not yet available
No reference posted for this study.