Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia

Acute Myeloid Leukemia, Adult Clinical Trial

Official title:

Efficacy and Safety of Decitabine in Combination With Low-dose Cytarabine as Inductive Treatment in Newly Diagnosed Elderly Patients With Acute Myeloid Leukemia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02985372
• Other study ID #: ESDCLDC in NDEAML
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: November 25, 2016
• Last updated: December 3, 2016
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: November 2016
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

This prospective multicenter clinical study was designed to assess the efficacy and safety of decitabine in combination with low-dose cytarabine induction treatment for elderly patients with newly diagnosed acute myeloid leukemia (AML).

Description:

All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).

Hydroxyurea was permitted as rescue medication if white blood count (WBC) was >20×109/L and but was discontinued at least 24h before decitabine treatment.

Supportive care including blood product transfusions, G-CSF, antiemetic medications, antiviral and antifungal medications, or empiric antibiotics may be used at the clinical discretion of the investigator.

Curative effect was evaluated after two cycles:

1. <5% blast in the marrow, enter into maintenance therapy (Group A)

2. ≥5% blast in the marrow, continue induction therapy two cycles,

① <5% blast in the marrow, enter into maintenance therapy (Group B);

② ≥5% blast in the marrow, dropped out of the study (Group C)

3. marrow blast decline <60%, dropped out of the study (Group C).

Maintenance therapy regimen:

1. Ara-C 1g/m2/d iv drip d1-4 1 cycle

2. DEC 15mg/m2/d iv drip d1-5 1 cycle

3. Ara-C 1g/m2/d iv drip d1-4 1 cycle

4. DEC 15mg/m2/d iv drip d1-5 1 cycle

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients with previously untreated non-M3 AML (diagnosed by the WHO2016 criteria).

2. Age: = 60 and = 75 years.

3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=2.5x upper limit of normal (ULN), total bilirubin = 1.5 ULN, serum creatinine < 2ULN.

5. Without central nervous system symptoms.

6. Willing to accept the follow-up.

7. Normal heart function(EF>50%). The subjects volunteer to sign the informed consent.

Exclusion Criteria:

1. With severe cardiac, renal or hepatic insufficiency.

2. With other cancers requiring treatment.

3. With other hematological diseases(e.g. Hemophilia, myelofibrosis, etc.).

4. With severe infection or metabolic disease(including tuberculosis and pulmonary aspergillosis).

5. Brain disorders or severe mental diseases which could limit compliance with study requirements.

6. Major operation within 3 weeks.

7. With HIV infection or AIDS-associated diseases.

8. Any drug abuse, medical, mental or social situations which would affect the results.

9. Hypersensitivity to cytarabine (not including drug fever or exanthema) or decitabine.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia, Adult
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Decitabine
All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).
• Cytarabine

Locations

Country	Name	City	State
n/a

Sponsors (18)

Lead Sponsor

Collaborator

Chunyan Ji

Affiliated hospital of Taishan medical university, Affiliated Hospital of Weifang Medical University, Binzhou Medical University Hospital, Central Hospital of Zibo, Heze Municipal Hospital, Jinan Central Hospital Affiliated to Shandong University, Jinan Military Genaral Hospital, Jining Medical University, Linyi People's Hospital, People's Hospital of Rizhao, Qilu Hospital(Qingdao), Shandong University, Qingdao University, Shandong Provincial Qianfoshan Hospital, Shengli Oilfield Central Hospital, Taian City Central Hospital, Weihai Municipal Hospital, Zibo First Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		three years	No
Primary	complete remission rate		three years	No
Secondary	Overall survival		three years	No
Secondary	progression-free survival		three years	No
Secondary	mortality rate		three years	No
Secondary	recurrence rate		three years	No