Clinical trial · Interventional
A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
A Multicenter Study to Confirm the Efficacy and Safety of Fludara i.v. (Fludarabine Phosphate, SH L 573), Administered in 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by an Observation Period of 23 Days) in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
- 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)
The purpose of this study is to confirm the efficacy and safety of fludarabine phosphate administered with dose increasing in 6 cycles (1 cycle: 5 treatment days every 28 days) in untreated chronic lymphocytic leukemia (CLL) patients with anemia and/or thrombocytopenia.
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, Lymphocytic, Chronic, B-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine Phosphate (Fludara) | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: Fludarabine Phosphate (Fludara)
Primary outcomes (1)
- measure
- Response rate of final overall evaluation up to 6 treatment cycles (at about 6 months)
- timeFrame
- Up to 6 treatment cycles (at about 6 months)
Secondary outcomes (2)
- measure
- Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings
- timeFrame
- Up to 6 treatment cycles (at about 6 months)
- measure
- Duration of response and change of peripheral blood findings
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically or cytologically confirmed CLL * Patients with hemoglobin concentration and/or platelet count below the institution's lower limit of normal * Patients who have not received cancer chemotherapy or radiotherapy Exclusion Criteria: * Patients with apparent infections (including viral infections) * Patients with serious complications (heart, liver, or kidney disease, etc.) * Patients with a serious bleeding tendency (e.g., DIC) * Patients with serious CNS symptoms * Patients with fever \>= 38°C (excluding tumor fever) * Patients with interstitial pneumonia or pulmonary fibrosis * Patients with active multiple cancers * Patients receiving other investigational products within 6 months before registration in this study * Patients with prior allergies to medications that are similar to the investigational product (purine nucleoside derivatives) * Women who are pregnant, of childbearing potential, or lactating
References
Publications (0)
Data not yet available