AzTrials
AzTrials

LeukemiaPhase 2NCT01235117

Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia

A Phase 2 study testing azacitidine and laboratory biomarker analysis in people with Leukemia, run by University of Leeds at 2 sites in United Kingdom.

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

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
azacitidine and laboratory biomarker analysis
How many people
30 participants
Where
2 sitesUnited Kingdom
Study dates
Jan 2010to May 2013
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

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:
  • All chronic myelomonocytic leukemia (CMML)-2 patients
  • CMML-1 patients meeting any of the following criteria:
  • Symptomatic bone marrow failure/myeloproliferation defined as any of the following:
  • Red cell transfusion dependence and pre-transfusion hemoglobin < 9.0 g/dL
  • Symptomatic anemia (hemoglobin < 11.5 g/dL)
  • Thrombocytopenia (platelet count < 50 x 10^9/L)
  • Symptomatic bleeding due to platelet functional defect or disseminated intravascular coagulation (DIC)/fibrinolysis
  • White cell count (WCC) > 50 x 10^9/L
  • Düsseldorf Score of intermediate or high risk for proliferative CMML-1 (i.e., WCC > 12 x 10^9/L)
  • International Prognostic Scoring System (IPSS) score of intermediate-2 or high risk for non-proliferative CMML-1 (i.e., WCC < 12 x 10^9/L)
  • Systemic symptoms including weight loss with no alternative explanation (10% of baseline weight within the past 6 months)
  • Symptomatic splenomegaly
  • Symptomatic extramedullary involvement (e.g. skin infiltration or serous effusions)
  • No CMML with eosinophilia and 5q33 abnormality

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Creatinine ≤ 2 times upper limit of normal
  • Not pregnant or nursing
  • Negative urine pregnancy test
  • Fertile patients must use at least 2 forms of effective contraception during study and for 3 months after completion of study therapy
  • No other active malignant disease including basal cell or squamous cell carcinoma of the skin
  • No known HIV or infectious hepatitis B or hepatitis C
  • No active infection
  • No known hypersensitivity to azacitidine or mannitol

PRIOR CONCURRENT THERAPY:

  • At least 28 days since other prior experimental drug or therapy
  • No prior chemotherapy for this disease except hydroxycarbamide
  • No other concurrent anticancer or investigational agents

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G12 0YN

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

Other trials in United Kingdom

About this study

Official title: A Phase 2 Study of Azacitidine in Chronic Myelomonocytic Leukemia (CMML)

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying the side effects of azacitidine and to see how well it works in treating patients with chronic myelomonocytic leukemia.

Read the detailed description

OBJECTIVES:

Primary

  • To assess the safety and tolerability of azacitidine in patients with chronic myelomonocytic leukemia (CMML).
  • To assess the overall response rate in these patients.

Secondary

  • To assess the incidence of clinical remission/complete remission or partial response in these patients.
  • To assess hematological improvement in patients treated with this drug.
  • To assess the overall survival of patients treated with this drug.
  • To assess progression-free survival of patients treated with this drug.
  • To assess the time to acute myeloid leukemia (AML) transformation of CMML.
  • To assess the time to death or AML transformation of CMML.
  • To assess the biological correlates.

OUTLINE: This is a multicenter study.

Patients receive azacitidine subcutaneously on days 1-5 and 8-9. Treatment repeats every 4 weeks for at least 6 courses in the absence of loss of response/disease progression or unacceptable toxicity. Patients undergo response evaluation after 6 courses or the last course of treatment. Responders may continue azacitidine until loss of response/disease progression or unacceptable toxicity.

Some patients undergo blood, bone marrow, and buccal swab sample collection periodically for correlative studies.

After completion of study treatment, patients are followed up for 1 month.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Conditions
Leukemia
Being tested
azacitidine, laboratory biomarker analysis
Keywords
chronic myelomonocytic leukemia
Medical subject headings
Leukemia, Leukemia, Myelomonocytic, Chronic

What participants receive

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

What is being measured

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

  1. Safety and tolerability

  2. Overall response rate

Secondary outcomes (7)

  1. Incidence of clinical remission/complete remission or partial response according to International Working Group (IWG) criteria

  2. Hematological improvement according to IWG criteria

  3. Overall survival

  4. Progression-free survival

  5. Time to acute myeloid leukemia (AML) transformation of CMML

  6. Time to death or AML transformation of CMML

  7. Biological correlates

Timeline

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

  1. First posted5 Nov 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2012
  4. Study completionMay 2013

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
Non-randomised
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01235117
Sponsor's protocol ID
CDR0000688119
Other IDs
CTRU-CMML-201, ISRCTN-21428905, EUDRACT-2008-006349-23, LEEDS-HM08/8540, EU-21082
Status last verified
Nov 2010
First submitted
4 Nov 2010
Last updated
26 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing azacitidine and laboratory biomarker analysis in people with Leukemia, run by University of Leeds at 2 sites in United Kingdom.

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

Who may be eligible to take part?

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 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. 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?

Safety and tolerability. The study lists 2 primary outcomes in all. 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 NCT01235117.

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 26 Aug 2013.

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