Status:
COMPLETED
Efficacy and Safety of rhTPO for the Treatment of Thrombocytopenia After Chemotherapy in AML Patients
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Thrombocytopenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
In this single-center, randomized, open-label, crossover, prospective clinical trial, a total of 120 AML patients who achieved remission will be randomized into two groups, of 60 cases in each group. ...
Detailed Description
In this single-center, randomized, open-label, crossover, prospective clinical trial, a total of 120 AML patients who achieved remission following induction chemotherapy will be recruited and randomiz...
Eligibility Criteria
Inclusion
- Age of 18-55 years;
- Patients that meet the diagnostic criteria of acute myeloid leukemia (except M3 and M7 subtypes), and achieve complete remission following induction chemotherapy and undergo consolidation therapy;
- Patients who require two successive cycles of DA (Ara-c 1.5 g/m2/q12 h and DNR 40 mg/m2/d on days 1-3) or MA regimen (Ara-C 1.5 g/m2/q12 h and MTZ 6 mg/m2/d on days 1-3) at the phase of consolidation therapy, or underwent consolidation therapy with administration of Ara-C 3 g/m2/q12 h alone, with dose adjustment of less than 10% Ara-C dose;
- Patients with the minimum platelet count of \< 30´109/L at the final cycle of chemotherapy during the induction stage;
- Patients without apparent liver or renal dysfunctions (serum levels of urea nitrogen, creatinine, aminotransferase and bilirubin were all ≤ 1.5 times of the normal upper limit);
- Patients without severe heart or lung dysfunctions;
- Patients with life expectancy of \> 12 weeks;
- Patients with ECOG score of ≤ 2;
- Patients are willing to participate in the study and sign the informed consent.
Exclusion
- Patients with a medical history of severe allergy to biologics;
- Patients with thromboembolic or hemorrhagic disease, or a recent medical history of thrombosis;
- Patients with a history of mental disorders;
- Pregnant or lactating patients, or patients with failure in use of contraception during the study period;
- Patients with M3 or M7 subtype;
- Patients with a platelet count of 1000 ´109/L at the start of the study;
- Patients with other factors which were considered not to be suitable to participate in the study by the investigators.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT02267993
Start Date
October 1 2014
End Date
August 31 2018
Last Update
May 30 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020