Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Drug: recombinant human thrombopoietin Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Thrombopoietin in the Treatment of Thrombocytopenia After Chemotherapy in Acute Myeloid Leukemia
Actual Study Start Date : October 2014
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 31, 2018


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. Duration of platelet count of < 20 ´ 109/Lat each cycle of chemotherapy. [ Time Frame: From Day1 after chemotherapy up to Day21 after chemotherapy ]

Secondary Outcome Measures :
  1. Time and dose of platelet transfusion at each cycle of chemotherapy [ Time Frame: From Day1 after chemotherapy up to Day21 after chemotherapy ]
  2. The minimum platelet count at each cycle of chemotherapy [ Time Frame: From Day1 after chemotherapy up to Day21 after chemotherapy ]
  3. 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 ]
  4. Number and grade of bleeding Adverse Events at each cycle of chemotherapy [ Time Frame: From Day1 after chemotherapy up to Day21 after chemotherapy ]
  5. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267993


Locations
Layout table for location information
China, Tianjin
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin, China, 300020
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jianxiang Wang, Dr Institute of Hematology & Blood Diseases Hospital

Layout table for additonal information
Responsible Party: wang, jianxiang, Director of Diagnosis and Treatment Center for Leukemia, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT02267993     History of Changes
Other Study ID Numbers: IHBDH-IIT2014010
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases