search
Back to results

Azacitidine in Treating Patients With Newly Diagnosed Previously Untreated or Secondary Acute Myeloid Leukemia Who Are Unsuitable For Intensive Chemotherapy

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
azacytidine
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), secondary acute myeloid leukemia, untreated adult acute myeloid leukemia, adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7)

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • De novo acute myeloid leukemia (AML)
    • AML secondary to prior hematological disease or cytotoxic treatment
  • Newly diagnosed or untreated disease
  • At least 20% blasts in the blood or bone marrow or extramedullary disease

  • Must be considered unsuitable for intensive chemotherapy due to ≥ 1 of the following:

    • High age or frail for the biologic age
    • Relevant comorbidities
    • Unwilling to undergo intensive chemotherapy
  • No chronic myelogenous leukemia or acute promyelocytic leukemia

PATIENT CHARACTERISTICS:

  • WHO performance status 0-3
  • Bilirubin ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • AST ≤ 2.5 times ULN
  • Serum creatinine ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study treatment
  • Patient compliance and geographic proximity allow proper staging and follow-up
  • No NYHA class III-IV heart failure or relevant cardiac arrhythmia
  • No active hematological/oncological disease other than AML
  • No psychiatric disorder precluding understanding of information on trial related topics or giving informed consent

  • No serious underlying medical condition in the judgment of the investigator, which could impair the ability of the patient to participate in the trial, including but not limited to, any of the following:

    • Active autoimmune disease
    • Uncontrolled diabetes
    • Active uncontrolled infection
    • HIV infection
    • Active chronic hepatitis B or C infection
  • No known allergy or hypersensitivity to azacitidine or mannitol

PRIOR CONCURRENT THERAPY:

  • No prior treatment for AML
  • No prior azacitidine or decitabine
  • No other concurrent experimental or investigational drugs or anticancer therapy
  • More than 30 days since participation in another clinical trial
  • No concurrent growth factors for use in afebrile and asymptomatic patients except to treat neutropenic infection

Sites / Locations

  • Kantonspital Aarau
  • Kantonsspital Baden
  • Universitaetsspital-Basel
  • Oncology Institute of Southern Switzerland
  • Inselspital Bern
  • Spitalzentrum Biel
  • Centre Hospitalier Universitaire Vaudois
  • Kantonsspital, Luzerne
  • Kantonsspital - St. Gallen
  • Hopitaux Universitaires de Geneve
  • UniversitaetsSpital Zuerich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm: 5-azacytidine

Arm Description

5-azacytidine 100 mg/m2/day s.c. on days 1-5 of a 28-day cycle.

Outcomes

Primary Outcome Measures

Best response (complete or partial response)

Secondary Outcome Measures

Time to response
Response duration
Best response status
Time to hematological improvement (HI)
Duration of HI
Event-free survival
Overall survival
Adverse events according to NCI CTCAE v3.0
Adjusted hospitalization time

Full Information

First Posted
August 20, 2008
Last Updated
April 9, 2013
Sponsor
Swiss Group for Clinical Cancer Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00739388
Brief Title
Azacitidine in Treating Patients With Newly Diagnosed Previously Untreated or Secondary Acute Myeloid Leukemia Who Are Unsuitable For Intensive Chemotherapy
Official Title
5-Azacytidine to Treat Acute Myeloid Leukemia in Elderly or Frail Patients Not Suitable for Intensive Chemotherapy. A Multicenter Phase II Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
No

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 how well azacitidine works in treating patients with acute myeloid leukemia who are unsuitable for treatment with intensive chemotherapy.
Detailed Description
OBJECTIVES: Primary To evaluate the efficacy of azacitidine in patients with newly diagnosed or untreated acute myeloid leukemia who are unsuitable for induction type chemotherapy because of age or relevant comorbidities. Secondary To evaluate survival and adverse events. OUTLINE: This is a multicenter study. Patients receive azacitidine subcutaneously on days 1-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), secondary acute myeloid leukemia, untreated adult acute myeloid leukemia, adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm: 5-azacytidine
Arm Type
Experimental
Arm Description
5-azacytidine 100 mg/m2/day s.c. on days 1-5 of a 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
azacytidine
Other Intervention Name(s)
Azacitidine, 5-azacytidine, Vidaza
Intervention Description
100 mg/m2/day s.c. on days 1-5 of a 28-day cycle
Primary Outcome Measure Information:
Title
Best response (complete or partial response)
Time Frame
within 6 months
Secondary Outcome Measure Information:
Title
Time to response
Time Frame
is defined as the time from trial registration until the date the criteria for either CR or PR are first met
Title
Response duration
Time Frame
is defined as the time from the date when the criteria for either CR or PR were first met until the date of relapse or death from any cause.
Title
Best response status
Time Frame
within 6 months
Title
Time to hematological improvement (HI)
Time Frame
is calculated for patients with HI and is defined as the time from trial registration until the date the criteria for HI are first met.
Title
Duration of HI
Time Frame
is defined as the time from the date when the criteria for HI were first met until the date of relapse or death from any cause.
Title
Event-free survival
Time Frame
is defined as the time from trial registration until progression, relapse or death from any cause, whichever occurs first.
Title
Overall survival
Time Frame
is defined as the time from trial registration until death from any cause.
Title
Adverse events according to NCI CTCAE v3.0
Time Frame
according to NCI CTCAE v3.0
Title
Adjusted hospitalization time
Time Frame
is defined as the time (nights) spent in hospital as a proportion of treatment duration (days).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: De novo acute myeloid leukemia (AML) AML secondary to prior hematological disease or cytotoxic treatment Newly diagnosed or untreated disease At least 20% blasts in the blood or bone marrow or extramedullary disease Must be considered unsuitable for intensive chemotherapy due to ≥ 1 of the following: High age or frail for the biologic age Relevant comorbidities Unwilling to undergo intensive chemotherapy No chronic myelogenous leukemia or acute promyelocytic leukemia PATIENT CHARACTERISTICS: WHO performance status 0-3 Bilirubin ≤ 3 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN AST ≤ 2.5 times ULN Serum creatinine ≤ 2.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after completion of study treatment Patient compliance and geographic proximity allow proper staging and follow-up No NYHA class III-IV heart failure or relevant cardiac arrhythmia No active hematological/oncological disease other than AML No psychiatric disorder precluding understanding of information on trial related topics or giving informed consent No serious underlying medical condition in the judgment of the investigator, which could impair the ability of the patient to participate in the trial, including but not limited to, any of the following: Active autoimmune disease Uncontrolled diabetes Active uncontrolled infection HIV infection Active chronic hepatitis B or C infection No known allergy or hypersensitivity to azacitidine or mannitol PRIOR CONCURRENT THERAPY: No prior treatment for AML No prior azacitidine or decitabine No other concurrent experimental or investigational drugs or anticancer therapy More than 30 days since participation in another clinical trial No concurrent growth factors for use in afebrile and asymptomatic patients except to treat neutropenic infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob Passweg, Prof
Organizational Affiliation
Hopitaux Universitaires de Geneve
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sabine Blum, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonspital Aarau
City
Aarau
ZIP/Postal Code
CH-5001
Country
Switzerland
Facility Name
Kantonsspital Baden
City
Baden
ZIP/Postal Code
CH-5404
Country
Switzerland
Facility Name
Universitaetsspital-Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Oncology Institute of Southern Switzerland
City
Bellinzona
ZIP/Postal Code
CH-6500
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Spitalzentrum Biel
City
Biel
ZIP/Postal Code
CH-2500
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Kantonsspital, Luzerne
City
Luzerne
ZIP/Postal Code
CH-6000
Country
Switzerland
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve
City
Thonex-Geneve
ZIP/Postal Code
CH-1226
Country
Switzerland
Facility Name
UniversitaetsSpital Zuerich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23547838
Citation
Passweg JR, Pabst T, Blum S, Bargetzi M, Li Q, Heim D, Stussi G, Gregor M, Leoncini L, Meyer-Monard S, Brauchli P, Chalandon Y; Swiss Group for Clinical Cancer Research (SAKK). Azacytidine for acute myeloid leukemia in elderly or frail patients: a phase II trial (SAKK 30/07). Leuk Lymphoma. 2014 Jan;55(1):87-91. doi: 10.3109/10428194.2013.790540. Epub 2013 May 2.
Results Reference
result

Learn more about this trial

Azacitidine in Treating Patients With Newly Diagnosed Previously Untreated or Secondary Acute Myeloid Leukemia Who Are Unsuitable For Intensive Chemotherapy

We'll reach out to this number within 24 hrs