High-dose Use of rhTPO in CIT Patients (HUrhTPOCITP)

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

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.

Study Overview

• Status: Unknown
• Conditions: Thrombocytopenia
• Intervention / Treatment: Drug: rhTPO

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xian Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Shenyang Pharmaceutical University
• Investigators: Principal Investigator: Lingxiao Zhang, doctor, First Affiliated Hospital of Xian Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2018
• Primary Completion (Anticipated): November 30, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 28, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: safety; efficacy; thrombocytopenia; rhTPO; real-world study
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: XJTU1AF2018LSK-056

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No