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B-cell Chronic Lymphocytic LeukemiaPhase 2NCT00321724

AZD2171 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

A Phase 2 study testing cediranib maleate and laboratory biomarker analysis in people with B-cell Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cediranib maleate and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
May 2006to May 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)
Show all 42Show fewer
  • 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 therapy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Central Cancer Treatment Group

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase II Trial of AZD2171 in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia Patients

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

Read the detailed description

OBJECTIVES:

  1. Evaluate the response rate in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL) treated with AZD2171.

II. Evaluate the toxicity of AZD2171 in patients with relapsed or refractory B-CLL.

III. Evaluate the complete response rate, progression-free and overall survival distributions, and duration of response in patients with relapsed or refractory B-CLL treated with AZD2171.

IV. Assess vascular endothelial growth factor receptor-2 (VEGFR-2) protein and phosphorylation levels in B-CLL cells using pretreatment samples and evaluate the association between Rai stage at study entry and clinical response to AZD2171.

  1. Perform preclinical testing of AZD2171 in the induction of B-CLL cell apoptosis/cell death using pretreatment samples, and evaluate the ability to downregulate the phosphorylation status of VEGFR-2 of B-CLL cells by comparing in vitro samples with and without AZD2171.

VI. Study the differences in in vitro levels of B-CLL cell apoptosis/cell death and alteration of VEGFR-2 phosphorylation using pretreatment samples with and without AZD2171 and how these differences correlate with clinical outcomes.

VII. Assess if the clinical responses are associated with changes in bone marrow vascularity.

OUTLINE: This is a multicenter study.

Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sampling and biopsies at baseline and periodically throughout study for biomarker and correlative studies.

After completion of study therapy, patients are followed periodically for up to 5 years from study entry.

Being tested
cediranib maleate, laboratory biomarker analysis
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cediranib maleateDrug

    Also called AZD2171, Recentin

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00321724
Study groupRoleWhat they receive
Treatment (cediranib maleate)ExperimentalPatients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: cediranib maleate; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed response defined to be an objective status of complete remission [CR], nodular partial remission [nPR], and partial remission [PR]

    Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

    Measured: Up to 5 years

Secondary outcomes (4)

  1. Complete response rate estimated by the number of confirmed complete responses (CR) observed in the trial divided by the total number of evaluable patients

    Exact binomial 95% confidence intervals for the true complete response rate will be calculated.

    Measured: Up to 5 years

  2. Overall survival

    Estimated using the Kaplan-Meier method.

    Measured: From the date of registration to the date of death, assessed up to 5 years

  3. Time to progression as estimated by Kaplan-Meier method

    Estimated using the Kaplan-Meier method.

    Measured: From the date of registration to the date of disease progression, assessed up to 5 years

  4. Duration of response

    Estimated using the Kaplan-Meier method.

    Measured: From the date at which the patient's objective status is first noted to be a response to the date that progression or death is documented, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00321724
Sponsor's protocol ID
NCI-2012-01825
Other IDs
NCCTG-N048F, U10CA025224, CDR0000467560
Status last verified
Jan 2013
First submitted
2 May 2006
Last updated
15 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cediranib maleate and laboratory biomarker analysis in people with B-cell Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 42 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed response defined to be an objective status of complete remission [CR], nodular partial remission [nPR], and partial remission [PR] (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00321724.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2013.

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