HUrhTPOCITP: High-dose Use of rhTPO in CIT Patients

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03633019

Collaborator

Shenyang Pharmaceutical University (Other)

Enrollment

Location

Arm

27.1

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The research studies the safety and efficacy of high-dose recombinant human TPO in solid tumor patients with moderate or severe thrombocytopenia induced by chemotherapy. Patients with platelet count lower than 50 x 109/L will be enrolled and treated with high-dose rhTPO (300-600U/kg/day) until the platelets increased by 50 x 109/L compared to the baseline or above 100 x 109/L. During the study, the blood routine test will be regularly performed according to the clinical routine (at least once every two days). Finally, the clinical data will be collected and analyzed to validate the efficacy and safety of high-dose rhTPO therapy.

Condition or Disease	Intervention/Treatment	Phase
Thrombocytopenia	Drug: rhTPO	Phase 4

Detailed Description

Chemotherapy-induced thrombocytopenia is a common toxic reaction of chemotherapeutic drugs, which may lead to dose reduction, delay or even termination of chemotherapy. Severe thrombocytopenia may cause bleeding and threaten patient's life. rhIL-11 and rhTPO are the only two drugs approved by China Food and Drug Administration for the treatment of chemotherapy-induced thrombocytopenia. The recommended dosage of rhTPO is 300U/kg. Clinical practice in the real world is full of changes and restraints. In the treatment of thrombocytopenia induced by chemotherapy, the actual dose of rhTPO is often below 300U/kg, due to factors such as Specs, economy and convenience. If the dose of rhTPO is insufficient, it can not give full play to the effect and thus can not achieve the purpose of rapid recovery of platelets. Previous clinical studies observed that the effect of rhTPO depends on the given dose. Dosage in the range of 75U-600U/kg of rhTPO were safe in human. While the 75U/kg dose group had no significant effect on the platelet count elevation, the platelet count in other three dose groups of 150U/kg, 300U/kg and 600U/kg increased by 24%, 32%, and 52% (P < 0.01). This research is a real-world study designed to verify the safety and efficacy of high-dose rhTPO in solid tumor patients with moderate or severe thrombocytopenia induced by chemotherapy. Patients with platelet count lower than 50 x 109/L will be enrolled and treated with high-dose rhTPO (300-600U/kg/day) until the platelets increased by 50 x 109/L compared to the baseline or above 100 x 109/L. During the study, the blood routine test will be regularly performed according to the clinical routine (at least once every two days) and the clinical data will be collected and analyzed. It is based on the patient's actual condition and the treatment measure is more consistent with the clinical practice. The results of this study are expected to provide new options and references for clinical treatment of thrombocytopenia induced by chemotherapy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

High-dose Use of Recombinant Human Thrombopoietin in Patients With Moderate or Severe Thrombocytopenia Induced by Chemotherapy

Actual Study Start Date :

Sep 28, 2018

Anticipated Primary Completion Date :

Nov 30, 2019

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: high-dose rhTPO rhTPO (300-600U/kg/day), ih, until the platelets increased by 50 x 109/L compared to the baseline or above 100 x 109/L	Drug: rhTPO high dose rhTPO ih Other Names: Recombinant Human Thrombopoietin Injection

Arm

Intervention/Treatment

Experimental: high-dose rhTPO

rhTPO (300-600U/kg/day), ih, until the platelets increased by 50 x 109/L compared to the baseline or above 100 x 109/L

Drug: rhTPO

high dose rhTPO ih

Other Names:

Recombinant Human Thrombopoietin Injection

Outcome Measures

Primary Outcome Measures

Duration of grade 3 and 4 thrombocytopenia [From time of randomization to the time of platelet counts recover to 75×109/L and above, assessed up to 20days]
Period of time when the platelet counts is lower 75×109/L, days

Secondary Outcome Measures

Adverse event [From randomization until 2 days after treatment completion or withdrawal of patient, whichever comes first, assessed up to 22days]
Any related adverse event during the study according to NCI-CTCAE 4.03, count
Platelets transfusion [From randomization to the time of platelets transfusion, assessed up to 20days]
Platelets transfusion during the study, number of times
platelet count nadir [From randomization to the time of the lowest value of platelets, assessed up to 20days]
the lowest platelet count

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with malignant solid tumor
moderate or severe chemotherapy-induced thrombocytopenia, platelet counts less than 50×109/L
plan to use rhTPO
be willing to adopt appropriate methods of contraception during the study period and 8 weeks after the end of the study; women of childbearing age must undergo pregnancy tests (serum or urine) within 7 days before entering the study and the result must be negative
volunteer to participate in the study, sign the informed consent, and cooperate with good compliance

Exclusion Criteria:

having other diseases that can lead to thrombocytopenia, such as aplastic anemia, myelodysplastic syndrome, leukemia, lymphoproliferative disease, immune thrombocytopenic purpura, thrombotic thrombocytopenic purpura, disseminated intravascular coagulation, thyroid disease, liver cirrhosis, hypersplenism, etc.
using other non-chemotherapeutic drugs that can cause thrombocytopenia, such as sulfonamides, etc
with long-term wound or great worry of gastrointestinal bleeding
with venous thrombosis that need thrombolytic or anticoagulant therapy or high risk of venous thromboembolism
with infection requiring antibiotic treatment
History of immunodeficiency, including HIV positive, organ transplantation and other acquired/congenital immunodeficiency disorders
patients with Hepatitis B(except inactive carrier) or Hepatitis C
with serious heart disease or cerebrovascular disease
with heart failure or heart failure history
with severe anemia that requires long-term use of recombinant human erythropoietin
congenital thrombocytopenia
has been used medication for thrombocytopenia
pregnancy or lactation
participate in other clinical researchers at the same time
not suitable to participate in the study in researchers'opinion