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

NCT02267993 | Completed Phase 4

• 1 other identifier: IIT2014010
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Duration of platelet count of < 20 ´ 109/Lat each cycle of chemotherapy.

  From Day1 after chemotherapy up to Day21 after chemotherapy

Secondary Outcomes (5)

• Time and dose of platelet transfusion at each cycle of chemotherapy

  From Day1 after chemotherapy up to Day21 after chemotherapy

• The minimum platelet count at each cycle of chemotherapy

  From Day1 after chemotherapy up to Day21 after chemotherapy

• Duration from the minimum platelet count to ≥ 20´109/L at each cycle of chemotherapy according to CTCAE(v4.0)

  From Day1 after chemotherapy up to Day21 after chemotherapy

• Number and grade of bleeding Adverse Events at each cycle of chemotherapy

  From Day1 after chemotherapy up to Day21 after chemotherapy

• Duration of hospital stay (from the first day of chemotherapy to discharge from hospital) at each cycle of chemotherapy

  From Day1 after chemotherapy up to Day21 after chemotherapy

Study Arms (2)

Arm A

EXPERIMENTAL

At the first chemotherapy cycle (treatment cycle), patients receive recombinant human thrombopoietin treatment. At the second chemotherapy cycle (control cycle), recombinant human thrombopoietin therapy is not given.

Drug: recombinant human thrombopoietin

Arm B

EXPERIMENTAL

At the first chemotherapy cycle (control cycle), recombinant human thrombopoietin therapy is not given; at the second chemotherapy cycle (treatment cycle), patients receive recombinant human thrombopoietin treatment.

Drug: recombinant human thrombopoietin

Interventions

recombinant human thrombopoietin DRUG

Patients received subcutaneous injection of recombinant human thrombopoietin at a dose of 300 U/kg body weight once daily at a platelet count of \< 50×109/L, and recombinant human thrombopoietin treatment ceased at a platelet count of ≥20×109/L if platelet is not transfused.

Also known as: rhTPO

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Thrombopoietin

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Jianxiang Wang, Dr

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 20, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 31, 2018
• Last Updated: May 30, 2025

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)