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Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia

Primary Purpose

Leukemia

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

azacitidine

laboratory biomarker analysis

About this trial

This is an interventional treatment trial for Leukemia focused on measuring chronic myelomonocytic leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Leeds Cancer Centre at St. James's University Hospital
Beatson West of Scotland Cancer Centre

Outcomes

Primary Outcome Measures

Safety and tolerability

Overall response rate

Secondary Outcome Measures

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

Hematological improvement according to IWG criteria

Overall survival

Progression-free survival

Time to acute myeloid leukemia (AML) transformation of CMML

Time to death or AML transformation of CMML

Biological correlates

Full Information

NCT ID

NCT01235117

First Posted

November 4, 2010

Last Updated

August 23, 2013

Sponsor

University of Leeds

1. Study Identification

Unique Protocol Identification Number

NCT01235117

Brief Title

Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Leeds

4. Oversight

5. Study Description

Brief 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. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia

Keywords

chronic myelomonocytic leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

azacitidine

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Primary Outcome Measure Information:

Title

Safety and tolerability

Title

Overall response rate

Secondary Outcome Measure Information:

Title

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

Title

Hematological improvement according to IWG criteria

Title

Overall survival

Title

Progression-free survival

Title

Time to acute myeloid leukemia (AML) transformation of CMML

Title

Time to death or AML transformation of CMML

Title

Biological correlates

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David T. Bowen, MD

Organizational Affiliation

Leeds Cancer Centre at St. James's University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Leeds Cancer Centre at St. James's University Hospital

City

Leeds

State/Province

England

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Beatson West of Scotland Cancer Centre

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G12 0YN

Country

United Kingdom

12. IPD Sharing Statement

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Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia

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