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

NCT01633099 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2012-07-06

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Decitabine

1. Number of Cycles: 4 cycles. 2. 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).

Sponsors & Collaborators

  • Xian-Janssen Pharmaceutical Ltd.

    collaborator INDUSTRY

  • Jianxiang Wang

    lead UNKNOWN

Principal Investigators

  • Jianxiang Wang, MD · Institute of Hematology, Hospital of Blood Disease, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-07-31
Completion
2016-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01633099 on ClinicalTrials.gov