NCT00321724

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

May 2, 2006

Last Update Submit

January 14, 2013

Conditions

B-cell Chronic Lymphocytic LeukemiaRefractory Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (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.

    Up to 5 years

Secondary Outcomes (4)

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

    Up to 5 years

  • Overall survival

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

  • Time to progression as estimated by Kaplan-Meier method

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

  • Duration of response

    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

Study Arms (1)

Treatment (cediranib maleate)

EXPERIMENTAL

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

Drug: cediranib maleateOther: laboratory biomarker analysis

Interventions

cediranib maleateDRUG

Given orally

Also known as: AZD2171, Recentin
Treatment (cediranib maleate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (cediranib maleate)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

cediranib

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Neil Kay

    North Central Cancer Treatment Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 4, 2006

Study Start

May 1, 2006

Primary Completion

May 1, 2007

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations

US(1)