Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years

Acute Myeloid Leukemia Clinical Trial

Official title:

A Multicenter，Open-label，Radonmized Study on the Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years Old

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02432872
• Other study ID #: IHBDH-IIT2015002
• Status: Recruiting
• Phase: N/A
• First received: April 29, 2015
• Last updated: October 6, 2016
• Start date: April 2015
• Est. completion date: May 2021

Study information

• Verified date: May 2016
• Source: Chinese Academy of Medical Sciences
• Contact: Chunlin - Zhou, MD
• Phone: +8613820429085
• Email: zcl7317[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the escalation dosage of Daunorubicin and cytarabine is effective and safety in the treatment of older adult Chinese acute myeloid leukemia（AML） patients aged 55 to 65 years.

Description:

the DA 3+7 regimen is the standard therapy in the AML treatment.Escalated dosage of daunorubicin in induction therapy is reported effective and result in a more rapid response and a higher response rate than does the conventional dose, without additional toxic effects in elderly AML patients between 60 to 65 years.Higher Overall survival rate and Event-free survival rate was obtained in escalated group compared with conventional dose. We are wondering if Chinese older AML patients can benefit from this escalated induction regimen.

High dose cytarabine in AML consolidation is reported improving the survival of elderly AML patients than the conventional dose，but it is not determined in Chinese older adult AML patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2021
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 65 Years

Eligibility

Inclusion Criteria:

• primary AML(except APL patients);

• ECOG PS:0-2

Exclusion Criteria:

• AML patient who has already received induction treatment, no matter what the outcome is;

• Treatment-related AML;

• Active cancer patients who's condition need to be treated;

• The one with serious infectious diseases(eg.uncontrolled tuberculosis or invasive pulmonary aspergillosis)

• Active heart disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Daunorubicin
defferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses
• Cytarabine
medium dosage cytarabine(1 g/m2 q12h for 3 days) compared with standard dosage cytarabine(100mg/m2 per day for 6 days)combinated with aclacinomycin(20mg per day for 6 days)for consolidation therapy.

Locations

Country	Name	City	State
China	Treatment and Diagnosis Center of Leukemia	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Jianxiang Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		3 years	Yes
Secondary	complete remission rate		2 months	No
Secondary	relapse free survival		3 years	No
Secondary	complete remission rate in different risk group		2 month	No
Secondary	treatment-related mortality		2 months	Yes