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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02267993
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
wang, jianxiang, Institute of Hematology & Blood Diseases Hospital

Tracking Information
First Submitted Date  ICMJE October 9, 2014
First Posted Date  ICMJE October 20, 2014
Last Update Posted Date March 22, 2019
Actual Study Start Date  ICMJE October 2014
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
Duration of platelet count of < 20 ´ 109/Lat each cycle of chemotherapy. [ Time Frame: From Day1 after chemotherapy up to Day21 after chemotherapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02267993 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
  • Time and dose of platelet transfusion at each cycle of chemotherapy [ Time Frame: From Day1 after chemotherapy up to Day21 after chemotherapy ]
  • The minimum platelet count at each cycle of chemotherapy [ Time Frame: 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) [ Time Frame: From Day1 after chemotherapy up to Day21 after chemotherapy ]
  • Number and grade of bleeding Adverse Events at each cycle of chemotherapy [ Time Frame: 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 [ Time Frame: From Day1 after chemotherapy up to Day21 after chemotherapy ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of rhTPO for the Treatment of Thrombocytopenia After Chemotherapy in AML Patients
Official Title  ICMJE A Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Thrombopoietin in the Treatment of Thrombocytopenia After Chemotherapy in Acute Myeloid Leukemia
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.
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 randomized into two groups, of 60 cases in each group. For one group, the treatment cycle is in the first chemotherapy cycle and the control cycle is in the second one. For another group, the treatment cycle is in the second chemotherapy cycle and the control cycle is in the first one.

Each subject is required to undergo two cycles of chemotherapy. At the treatment cycle, patients received subcutaneous injection of rhTPO at a dose of 300 U/kg body weight once daily at a platelet count of < 50×109/L, and rhTPO treatment ceased at a platelet count of ≥20×109/L if platelet is not transfused. At the control cycle, rhTPO therapy is not given.

Each subject is required to be followed up for successive two chemotherapy cycles following inclusion in this study. During the follow-up period, routine blood test is performed once every other day, and platelet transfusion is recorded.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thrombocytopenia
Intervention  ICMJE Drug: recombinant human thrombopoietin
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.
Other Name: rhTPO
Study Arms  ICMJE
  • Experimental: Arm A
    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.
    Intervention: Drug: recombinant human thrombopoietin
  • Experimental: Arm B
    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.
    Intervention: Drug: recombinant human thrombopoietin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2019)
58
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2014)
120
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02267993
Other Study ID Numbers  ICMJE IHBDH-IIT2014010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party wang, jianxiang, Institute of Hematology & Blood Diseases Hospital
Study Sponsor  ICMJE Institute of Hematology & Blood Diseases Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jianxiang Wang, Dr Institute of Hematology & Blood Diseases Hospital
PRS Account Institute of Hematology & Blood Diseases Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP