Efficacy and Safety of rhTPO for the Treatment of Thrombocytopenia After Chemotherapy in AML Patients

• Status: Completed
• Trial end date: 2018-08-31
• Target enrollment: 0
• Participant gender: All

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. Each subject is required to undergo two cycles of chemotherapy. At the treatment cycle, patients received subcutaneous injection of rhTPO. At the control cycle, rhTPO therapy is not given.The safety of rhTPO is evaluated by the monitoring of liver and renal functions, blood coagulation, and TPO-neutralizing antibody, and adverse events associated with rhTPO treatment are recorded during the study period.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital

Criteria

Inclusion Criteria:

1. Age of 18-55 years;

2. 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;

3. 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;

4. Patients with the minimum platelet count of < 30´109/L at the final cycle of chemotherapy during the induction stage;

5. 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);

6. Patients without severe heart or lung dysfunctions;

7. Patients with life expectancy of > 12 weeks;

8. Patients with ECOG score of ≤ 2;

9. Patients are willing to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Patients with a medical history of severe allergy to biologics;

2. Patients with thromboembolic or hemorrhagic disease, or a recent medical history of thrombosis;

3. Patients with a history of mental disorders;

4. Pregnant or lactating patients, or patients with failure in use of contraception during the study period;

5. Patients with M3 or M7 subtype;

6. Patients with a platelet count of 1000 ´109/L at the start of the study;

7. Patients with other factors which were considered not to be suitable to participate in the study by the investigators.