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

NCT00739388 | Completed Phase 2

• 3 other identifiers: SAKK 30/07SWS-SAKK-30/07CDR0000612029
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 11

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.

Conditions

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)

Outcome Measures

Primary Outcomes (1)

• Best response (complete or partial response)

  within 6 months

Secondary Outcomes (9)

• Time to response

  is defined as the time from trial registration until the date the criteria for either CR or PR are first met

• Response duration

  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.

• Best response status

  within 6 months

• Time to hematological improvement (HI)

  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.

• Duration of HI

  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.

Study Arms (1)

Arm: 5-azacytidine

EXPERIMENTAL

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

Drug: azacytidine

Interventions

azacytidine DRUG

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

Also known as: Azacitidine, 5-azacytidine, Vidaza

Arm: 5-azacytidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (11)

Kantonspital Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden

Baden, CH-5404, Switzerland

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Oncology Institute of Southern Switzerland

Bellinzona, CH-6500, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Spitalzentrum Biel

Biel, CH-2500, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital, Luzerne

Luzerne, CH-6000, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Hopitaux Universitaires de Geneve

Thonex-Geneve, CH-1226, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 23547838 RESULT

MeSH Terms

Conditions

Leukemia; Congenital Abnormalities; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Monocytic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jakob Passweg, Prof

  Hopitaux Universitaires de Geneve

  STUDY CHAIR

• Sabine Blum, MD

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 21, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: November 1, 2012
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

CH (11)