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Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients

Primary Purpose

Untreated Adult Acute Myeloid Leukemia, Effect of Drugs, Drug Safety

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Decitabine

About this trial

This is an interventional treatment trial for Untreated Adult Acute Myeloid Leukemia focused on measuring decitabine, acute myeloid leukemia, elderly patient

Eligibility Criteria

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

Inclusion Criteria:

Clinical diagnosis of acute myeloid leukemia.De novo or secondary AML.
Age >= 60years,female and male.
Before the enrollment，WBC < 40×10E9/L，Plt > 20×10E9/L（Hydroxyurea is permitted.）
In 2 weeks before the enrollment，total bilirubin < 1.5×ULN，ALT < 2.5×ULN；GGT < 2.5×ULN ，Scr < 2.0×ULN or creatinine clearance rate ≥ 50 ml/min（Cockroft-Gault）.
Before the enrollment，patients must be free from the toxicity caused by the former treatment.Received no chemotherapy in the last 4 weeks and no nitrosourea in the last 6 weeks.
Contraception must be taken to avoid pregnancy during the study.
ECOG 0,1, or 2, predicted lifetime longer than 12 weeks.
Patients must sign the informed consent prior to any study related screening procedures being performed.

Exclusion Criteria:

Acute promyelocytic leukemia.
Chromosome and genetic abnormalities related with t（8; 21）、inv（16）、t（15; 17）.
Central nervous system leukemia.
Bone marrow dry tap.
Patients received stem cell transplantation or chemotherapy containing azacitidine,cytarabine or decitabine in last one year, radiation therapy in last 14 days,lenalidomide in 30 days before included.
Patients suffered from autoimmune hemolytic anemia or immune thrombocytopenia.
Patients suffered from non-leukemia related comorbidities that will cause dysfunction of organs.
Patients suffered from unstable angina or （NYHA）3/4 Congestive heart failure.
Patients suffered from chronic respiratory disease and needed continued oxygen.
Other active malignancy.
Active HBV,HCV or AIDS patients.
Uncontrolled virus or bacterium infection.
The investigator believe that patients who are not suitable for this trial.
Severe mental or body disorders which will interfere the research such as uncontrolled heart,lung diseases,diabetes,etc.
Allergic to decitabine or its accessory.
Patients received other researches in last 30 days.
Without contraception.
Complications causing organ dysfunction which are not caused by AML.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Decitabine, CR rate,OS,EFS,RFS

Arm Description

Therapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia.

Outcomes

Primary Outcome Measures

Complete response rate after induction chemotherapy with decitabine

Overall survival rate

Event free survival rate

Relapse free survival rate

Secondary Outcome Measures

Adverse events of decitabine for elderly AML patients

Weight of elderly AML patients

ECOG(Eastern Cooperative Oncology Group) score for elderly AML patients

Physical examination of decitabine for elderly AML patients

Blood pressure of elderly AML patients

Respiratory rate of elderly AML patients

Heart rate of elderly AML patients

Body temperature of elderly AML patients

ECG of elderly AML patients

Bone marrow condition of elderly AML patients

Full Information

NCT ID

NCT01633099

First Posted

June 24, 2012

Last Updated

July 4, 2012

Sponsor

Jianxiang Wang

Collaborators

Xian-Janssen Pharmaceutical Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01633099

Brief Title

Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients

Official Title

The Clinical Research About the Therapeutic Effect and Safety of 10 Days Regimen With Single-agent of Decitabine for Elderly AML Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (undefined)

Primary Completion Date

July 2014 (Anticipated)

Study Completion Date

July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jianxiang Wang

Collaborators

Xian-Janssen Pharmaceutical Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to confirm the safety and the therapeutic effect of Decitabine in the treatment of elderly Acute Myeloid Leukemia (AML) patients.

Detailed Description

The outcome of the elderly AML patients is very poor. No obvious progress was achieved in this field. Decitabine is a kind of specific DNA methylation shift enzyme inhibitor. It can reverse the DNA methylation and induce the differentiation and apoptosis of the tumor cells. Recent studies about decitabine in the treatment for elderly AML patients had achieved inspiring results and indicated that low dose decitabine maybe a good choice for elderly AML patients. So in this research the investigators plan to evaluate the safety and the therapeutic effect of decitabine in the treatment of elderly AML patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Untreated Adult Acute Myeloid Leukemia, Effect of Drugs, Drug Safety

Keywords

decitabine, acute myeloid leukemia, elderly patient

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Decitabine, CR rate,OS,EFS,RFS

Arm Type

Other

Arm Description

Therapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia.

Intervention Type

Drug

Intervention Name(s)

Decitabine

Other Intervention Name(s)

Dacogen

Intervention Description

Number of Cycles: 4 cycles. Dose and drug delivery(decitabine): The 1st cycle: 20 mg/m2, (iv,>1 hour) d1-10 of each 28 day cycle. The 2nd-4th cycle:If bone marrow blast cells≥5%, the following cycle is the same as the 1st cycle. If bone marrow blast cells<5%, the following cycle:decitabine 20 mg/m2, (iv,>1h) on d1-5 of each 28 day cycle. If Grade 4 neutropenia（<0.5×10E9/L）come arise after 5 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 4 days(20 mg/m2, IV ,>1h, on d1-4 of each 28 day cycle).If Grade 4 neutropenia（<0.5×10E9/L）come arise after 4 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 3 days(20 mg/m2, IV,>1h, on d1-3 of each 28day cycle).

Primary Outcome Measure Information:

Title

Complete response rate after induction chemotherapy with decitabine

Time Frame

21 days after the induction chemotherapy

Title

Overall survival rate

Time Frame

Up to 46 months after inclusion

Title

Event free survival rate

Time Frame

Up to 46 months after inclusion

Title

Relapse free survival rate

Time Frame

Up to 46 months after inclusion

Secondary Outcome Measure Information:

Title

Adverse events of decitabine for elderly AML patients

Time Frame

Up to 46 months

Title

Weight of elderly AML patients

Time Frame

Up to 46 months

Title

ECOG(Eastern Cooperative Oncology Group) score for elderly AML patients

Time Frame

Up to 46 months

Title

Physical examination of decitabine for elderly AML patients

Time Frame

Up to 46 months

Title

Blood pressure of elderly AML patients

Time Frame

Up to 46 months

Title

Respiratory rate of elderly AML patients

Time Frame

Up to 46 months

Title

Heart rate of elderly AML patients

Time Frame

Up to 46 months

Title

Body temperature of elderly AML patients

Time Frame

Up to 46 months

Title

ECG of elderly AML patients

Time Frame

Up to 46 months

Title

Bone marrow condition of elderly AML patients

Time Frame

Up to 46 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of acute myeloid leukemia.De novo or secondary AML. Age >= 60years,female and male. Before the enrollment，WBC < 40×10E9/L，Plt > 20×10E9/L（Hydroxyurea is permitted.） In 2 weeks before the enrollment，total bilirubin < 1.5×ULN，ALT < 2.5×ULN；GGT < 2.5×ULN ，Scr < 2.0×ULN or creatinine clearance rate ≥ 50 ml/min（Cockroft-Gault）. Before the enrollment，patients must be free from the toxicity caused by the former treatment.Received no chemotherapy in the last 4 weeks and no nitrosourea in the last 6 weeks. Contraception must be taken to avoid pregnancy during the study. ECOG 0,1, or 2, predicted lifetime longer than 12 weeks. Patients must sign the informed consent prior to any study related screening procedures being performed. Exclusion Criteria: Acute promyelocytic leukemia. Chromosome and genetic abnormalities related with t（8; 21）、inv（16）、t（15; 17）. Central nervous system leukemia. Bone marrow dry tap. Patients received stem cell transplantation or chemotherapy containing azacitidine,cytarabine or decitabine in last one year, radiation therapy in last 14 days,lenalidomide in 30 days before included. Patients suffered from autoimmune hemolytic anemia or immune thrombocytopenia. Patients suffered from non-leukemia related comorbidities that will cause dysfunction of organs. Patients suffered from unstable angina or （NYHA）3/4 Congestive heart failure. Patients suffered from chronic respiratory disease and needed continued oxygen. Other active malignancy. Active HBV,HCV or AIDS patients. Uncontrolled virus or bacterium infection. The investigator believe that patients who are not suitable for this trial. Severe mental or body disorders which will interfere the research such as uncontrolled heart,lung diseases,diabetes,etc. Allergic to decitabine or its accessory. Patients received other researches in last 30 days. Without contraception. Complications causing organ dysfunction which are not caused by AML.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianxiang Wang, MD

Organizational Affiliation

Institute of Hematology, Hospital of Blood Disease, Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

17315155

Citation

Burnett AK, Milligan D, Prentice AG, Goldstone AH, McMullin MF, Hills RK, Wheatley K. A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment. Cancer. 2007 Mar 15;109(6):1114-24. doi: 10.1002/cncr.22496.

Results Reference

background

Links:

URL

http://www.chinablood.com.cn/

Description

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Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients

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