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

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ClinicalTrials.gov Identifier: NCT02432872
Recruitment Status : Recruiting
First Posted : May 4, 2015
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
Jianxiang Wang, Chinese Academy of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Daunorubicin Drug: Cytarabine Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter,Open-label,Radonmized Study on the Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years Old
Study Start Date : April 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2021


Arm Intervention/treatment
Experimental: escalated daunorubicin
Daumorubicin 60mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.
Drug: Daunorubicin
defferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses
Other Name: daunomycin

Drug: 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.
Other Name: cytosine arabinoside

Active Comparator: standard daunorubicin
Daunorubicin 45mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.
Drug: Daunorubicin
defferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses
Other Name: daunomycin

Drug: 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.
Other Name: cytosine arabinoside

Experimental: medium dosage cytarabine
1g/m2 q12h for 3 days as consolidation therapy.
Drug: 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.
Other Name: cytosine arabinoside

Active Comparator: standard dosage cytarabine
100mg/m2 cytarabine for 6 days combined with aclacinomycin 20mg per day for 6 days as consolidation therapy.
Drug: 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.
Other Name: cytosine arabinoside




Primary Outcome Measures :
  1. overall survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. complete remission rate [ Time Frame: 2 months ]
  2. relapse free survival [ Time Frame: 3 years ]
  3. complete remission rate in different risk group [ Time Frame: 2 month ]
  4. treatment-related mortality [ Time Frame: 2 months ]


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Ages Eligible for Study:   55 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432872


Contacts
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Contact: Chunlin - Zhou, MD +8613820429085 zcl7317@sina.com

Locations
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China, Tianjin
Treatment and Diagnosis Center of Leukemia Recruiting
Tianjin, Tianjin, China, 300020
Contact: Jianxiang Wang, MD    +862223909120    wangjx@medmail.com.cn   
Contact: Chunlin Zhou, MD    +8613820429085    zcl7317@sina.com   
Sponsors and Collaborators
Jianxiang Wang
Investigators
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Principal Investigator: Jianxiang Wang, MD Chinese Academy of Medical Sciences

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Responsible Party: Jianxiang Wang, vise-president, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02432872     History of Changes
Other Study ID Numbers: IHBDH-IIT2015002
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Daunorubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors