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Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesPhase 2NCT00475150

Cediranib Maleate in Treating Patients With Relapsed, Refractory, or Untreated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

A Phase 2 study testing cediranib maleate and laboratory biomarker analysis in people with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), run by National Cancer Institute (NCI) at 5 sites 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 cediranib maleate works in treating patients with relapsed, refractory, or untreated acute myeloid leukemia or high-risk myelodysplastic syndrome. 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
39 participants
Where
5 sitesUnited States
Study dates
May 2008to Mar 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically or cytologically confirmed acute myeloid leukemia (AML) ormyelodysplastic syndromes meeting 1 of the following criteria:
  • Relapsed AML meeting any of the following criteria:
  • Good-risk cytogenetics (inv[16], t[8;21], or t[15;17]) in second orgreater relapse
  • Patients with AML t(15;17) must have failed prior tretinoin and arsenic-containing regimens AND progressed orrelapsed within 12 months of therapy
  • In first or greater relapse
  • Resistant AML
Show all 54Show fewer
  • Unable to achieve first complete remission after at least 2 inductionregimens
  • Untreated AML meeting any of the following criteria:
  • At least 60 years of age
  • Preceding MDS
  • MDS
  • International Prognosis Scoring System (IPSS) risk groupof intermediate-2 or higher
  • Patients with relapsed disease after allogeneic hematopoietic stem cell transplantation (HSCT) must be off allimmunosuppressive medications for at least 30 days and have no symptoms orsigns of graft-vs-host disease
  • No active CNS metastasis
  • Patients with clinical signs of CNS disease or a history of CNS diseasewithin the past 6 months are required to undergo lumbar puncture to excludeCNS involvement
  • No symptomatic leukostasis or requirement for leukapheresis
  • Not eligible for allogeneic HSCTAND no suitable donor at the time of study entry
  • Patients who areeligible for HSCT, informed of the option, and choose not to proceed to HSCTare allowed
  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Bilirubin normal
  • AST and/or ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • No proteinuria ≥ 1+ on 2 consecutive urinalysis taken ≥ 1 week apart
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No HIV positivity
  • LVEF ≥ 45% by echocardiography
  • Mean QTc ≤ 500 msec (with Bazett's correction)
  • No other significant ECG abnormality
  • No history of familial long QT syndrome
  • No disseminated intravascular coagulation
  • No history of allergic reactions attributed to compounds of similar chemical orbiological composition to AZD2171
  • No concurrent uncontrolled illness, including, but not limited to, any of the following:
  • Hypertension
  • Thyroid disease
  • Ongoing or active infection
  • Symptomatic congestive heartfailure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • NYHA class III-IV heart disease
  • NYHA class II heart disease controlled with treatment allowed
  • Psychiatric illness or social situations that would limit study compliance
  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (6 weeks fornitrosoureas or mitomycin C), radiotherapy, or major surgery and recovered
  • Hydroxyurea allowed to control peripheral blast count> 20,000/mcL prior to study entry and during the first 3 days of study therapy
  • More than 4 weeks since prior and no concurrent growth factor or other cytokine support
  • At least 30 days since prior investigational agents or participation in aninvestigational trial
  • No more than 3 prior courses of induction chemotherapy
  • Induction chemotherapyis defined as that intended to induce complete remission and given at a time thatthe patient has active disease
  • No concurrent CYP interactive medications
  • No other concurrent investigational agents
  • No concurrent drugs or biologics with proarrhythmic potential
  • Prior and concurrent hydroxyurea allowed to control peripheral blast count> 20,000/mcL during the first 3 days of study therapy

Who cannot join

None listed.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Howard University Hospital

    Washington D.C., District of Columbia, 20060

Other trials in United States

About this study

Official title: A Phase II Study of AZD2171 in the Treatment of Patients With Acute Leukemia and Myelodysplastic Syndrome.

This phase II trial is studying how well cediranib maleate works in treating patients with relapsed, refractory, or untreated acute myeloid leukemia or high-risk myelodysplastic syndrome. Cediranib maleate 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Evaluate the objective response rate in patients with relapsed, refractory, or untreated acute myeloid leukemia or high-risk myelodysplastic syndromes treated with AZD2171 (cediranib maleate).

SECONDARY OBJECTIVES:

  1. Determine the toxicity of this drug in these patients. II. Determine the response duration, event-free survival, and overall survival of patients treated with this drug.

III. Determine the hematological response rate in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (acute myeloid leukemia vs myelodysplastic syndromes).

Patients receive oral cediranib maleate once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy at baseline and on day 28 for correlative studies. Samples are analyzed for circulating endothelial cells, VEGF receptor expression, and leukemic blasts via flow cytometry and microvessel density via histopathological techniques.

After completion of study treatment, patients are followed up at 3 months and then every 6 months for up to 2 years.

Being tested
cediranib maleate, laboratory biomarker analysis
Medical subject headings
Congenital Abnormalities, Leukemia, Myeloid, Acute

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 NCT00475150
Study groupRoleWhat they receive
Treatment (enzyme inhibitor therapy)ExperimentalPatients receive oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses 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. The Number of Confirmed Disease Response: Complete Response (CR), Partial Response (PR), and Hematologic Improvement (HI). A Confirmed Response is Defined to be an Objective Status of CR, PR, or HI Noted on 2 Consecutive Evaluations.

    Complete Response (CR) requires a repeat bone marrow with < 5% myeloblasts, hemoglobin ≥ 11 g/dl, neutrophils ≥ 1000/mm3, platelets ≥ 100,000/mm3, and no circulating blasts.

    Partial Response (PR) requires a bone marrow blast reduction of 50% or more, hemoglobin ≥ 11 g/dl, neutrophils ≥ 1000/mm3, platelets ≥ 100,000/mm3, and no circulating blasts.

    Hematologic Improvement (HI) requires one of the following:

    1. RBC transfusion independent participants are required to have >1.5 g/dL increase in hemoglobin,
    2. RBC transfusion-dependent participants are required to be transfusion independent,
    3. A 100% increase, and an absolute increase over 500mm^3 in Absolute Neutrophil Count,
    4. Participants with a pretreatment platelet count over 20,000/mm3 require an absolute increase of 30,000/mm^3 or more,
    5. Participants with platelet count below 20,000/mm3 require an increase over 20,000/mm^3 and by at least 100%.

    Measured: At the end of cycles 1 and 3 and every 3 cycles thereafter up to 26 cycles

Secondary outcomes (4)

  1. Overall Survival

    Defined as the time from date of registration to date of death due to any cause or date last known alive. The distribution of survival time will be estimated using the method of Kaplan-Meier.

    Measured: Every cycle during treatment and every 6 months for up to 2 years after completion of study treatment

  2. Progression-free Survival

    Defined as the time from date of registration to date that disease progression was documented, death, or last date that progression-free status was documented, whichever comes first. Estimated using the method of Kaplan-Meier.

    Disease progression is defined as one of the following:

    • A ≥ 50% increase in bone marrow blasts from the best response, or
    • A 50% or greater decrement from maximum remission/response levels in neutrophils or platelets, or
    • A reduction in hemoglobin concentration by at least 1.5 g/dl, or
    • Transfusion dependence (without alternative explanation and sustained for at least 2 weeks).

    Measured: Every 3 courses during treatment and then at 3 months and every 6 months for up to 2 years after completion of study treatment

  3. Duration of Response

    Measured from the time criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Estimated using the method of Kaplan-Meier.

    Measured: Every 3 courses up to 26 courses

  4. The Number of Patients That Report Adverse Events Possibly, Probably, or Definitely Related to AZD2171.

    Graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. All adverse events determined to be possibly, probably, or definately related to AZD2171 are included in this analysis.

    Measured: Continuously during treatment up to 26 courses

Timeline

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

  1. First posted17 May 2007 (estimated)
  2. Study startMay 2008
  3. Primary completionJul 2011
  4. Study completionMar 2012

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00475150
Sponsor's protocol ID
NCI-2009-00129
Other IDs
NCI-2009-00129, CDR0000544833, MCCRC-MC048H, MC048H, 7135, N01CM62205, P30CA015083
Status last verified
Dec 2016
First submitted
16 May 2007
Last updated
15 Feb 2017

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cediranib maleate and laboratory biomarker analysis in people with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), run by National Cancer Institute (NCI) at 5 sites 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 54 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 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Yes. Results are posted in the registry (first posted 10 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Number of Confirmed Disease Response: Complete Response (CR), Partial Response (PR), and Hematologic Improvement (HI). A Confirmed Response is Defined to be an Objective Status of CR, PR, or HI Noted on 2 Consecutive Evaluations. (time frame: At the end of cycles 1 and 3 and every 3 cycles thereafter up to 26 cycles). 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 NCT00475150.

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 Feb 2017.

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