Clinical trial · Interventional
AZD2171 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
A Phase II Trial of AZD2171 in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia Patients
NCT00321724CI-TRIAL-00008909completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This phase II trial is studying how well AZD2171 works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia. AZD2171 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer cells
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Refractory Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cediranib maleate | Drug | Cediranib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cediranib maleate)
- description
- Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: cediranib maleate
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Confirmed response defined to be an objective status of complete remission [CR], nodular partial remission [nPR], and partial remission [PR]
- timeFrame
- Up to 5 years
- description
- Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Secondary outcomes (4)
- measure
- Complete response rate estimated by the number of confirmed complete responses (CR) observed in the trial divided by the total number of evaluable patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histological confirmation of B-cell chronic lymphocytic leukemia (B-CLL)
* Peripheral blood lymphocyte count \> 5,000/mm³
* Small to moderate peripheral blood lymphocytes with ≤ 55% prolymphocytes
* Bone marrow aspirate with ≥ 30% lymphoid cells
* Monoclonality of B lymphocytes by immunophenotyping, demonstrating all of the following:
* B-cell markers with CD5 antigen in the absence of other pan-T-cell markers (CD3, CD2, etc.)
* CD19 and/or CD20
* Expression of CD23 on the CLL cells OR dim B-cell expression of kappa or lambda light chains
* Disease must be refractory to or progressive after treatment with at least 1 course containing a purine nucleoside analog (e.g., fludarabine, cladribine, or pentostatin)
* Life expectancy \> 6 months
* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 50,000/mm³
* Hemoglobin ≥ 8 g/dL
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Patients with Gilbert's syndrome may have a bilirubin ≥ 1.5 times ULN
* AST and ALT ≤ 2.5 times ULN
* Creatinine ≤ 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of allergies to compounds similar to AZD2171
* QTc prolongation \< 500 msec
* No other significant ECG abnormality
* No history of familial long QT syndrome
* Proteinuria \< 1+ by dipstick OR protein \< 1 g/24 hr urine collection
* No known HIV positivity
* No New York Heart Association (NYHA) class III or IV disease
* NYHA class II disease controlled with treatment and monitoring allowed
* No other uncontrolled illness including, but not limited to, the following:
* Hypertension
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situations that would limit compliance
* See Disease Characteristics
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, anti-vascular endothelial growth factor (VEGF) treatment, or major surgery and recovered
* More than 30 days since prior investigational agents
* No concurrent drugs or biologics with proarrhythmic potential
* No other concurrent investigational agents
* No other concurrent anticancer therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.