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Herombopag for Chemotherapy-induced Thrombocytopenia

Primary Purpose

Chemotherapy-induced Thrombocytopenia, Herombopag

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Herombopag

About this trial

This is an interventional treatment trial for Chemotherapy-induced Thrombocytopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged ≥18 years old, male or female;
Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT); Ineffective after repeated treatment with rhTPO or IL-11；
Stop radiotherapy or chemotherapy for more than 1 month;
Platelet counts <30 ×10^9/L, and bleeding tendency;
Estimated survival period ≥ 6 months；
People who are willing to sign the informed consent voluntarily and follow the research program.
Liver and kidney function<1.5×upper limit of normal, qualified for physical examination；
Subject is practicing an acceptable method of contraception. Women of childbearing potential must have a negative serum pregnancy test in the whole study;

Exclusion Criteria:

Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；
Patients with poor compliance;
Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.
There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator；
Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis；
Those who have received allogeneic stem cell transplantation or organ transplantation in the past；
Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up；
Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared；
Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)；
Patients with sepsis or patients with other irregular bleeding；
Patients taking antiplatelet drugs at the same time；
Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients；
Pre-existing cardiac disease, including congestive heart failure of New York Heart Association [NYHA] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT >450msec or QTc > 480 for patients with a Bundle Branch Block;
Researchers believe that patients should not participate in the test of any other condition.

Sites / Locations

Chinese Academy of Medical Science and Blood Disease HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

50 subjects with chemotherapy-induced thrombocytopenia

Arm Description

50 enrolled subjects will be picked up to take Herombopag at the indicated dose.

Outcomes

Primary Outcome Measures

Changes of the platelet counts after the treatment of Herombopag at week 12

The investigator will assess the changes of the platelet counts after the treatment of Herombopag from week 1 to week 24，and calculate the proportion of subjects ≥ 30 × 10^9/L ， 50 × 10^9/L and 100 × 10^9/L at week 12.

Changes of the platelet counts after the treatment of Herombopag at week 24

Secondary Outcome Measures

Incidence of adverse events after the treatment of Herombopag

The investigator will observe incidence of adverse events after the treatment of Herombopag, including thrombosis, diarrhea, skin rash, abnormal liver function and so on.

Changes of concentration of TPO in peripheral blood

The investigator will observe the concentration of TPO in peripheral blood before and after the treatment of Herombopag, if necessary.

Changes of concentration of TPO antibodies，anti-c-Mpl antibodies and TPO neutralizing antibodies in peripheral blood

The investigator will observe the concentration of antibodies in peripheral blood before and after the treatment of Herombopag, if necessary

Full Information

NCT ID

NCT05236582

First Posted

January 20, 2022

Last Updated

January 24, 2023

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Collaborators

Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University Second Hospital, Tianjin Third Central Hospital, Tianjin People's Hospital, Henan Cancer Hospital, The Second Affiliated Hospital of Kunming Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05236582

Brief Title

Herombopag for Chemotherapy-induced Thrombocytopenia

Official Title

Herombopag for Chemotherapy-induced Thrombocytopenia: a Prospective Multi-center One-arm Study in Solid Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 14, 2022 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the efficacy and safety of Herombopag to treat chemotherapy-induced thrombocytopenia in Solid Tumors

Detailed Description

The investigator had registered a clinical trial of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）. Due to the late launch of Herombopag in China, the investigator also collected the information of Herombopag in the treatment of chemotherapy-induced thrombocytopenia according to the protocal of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）. This is a single-arm study to evaluate the safety and efficacy of Herombopag to treat chemotherapy-induced thrombocytopenia（CIT）. These subjects have been treated with recombinant human thrombopoietin（rhTPO） or interleukin 11（IL-11） before, the platelets can rise to normal or reach the effective standard, but after the re-application, the effective standard is not reached, or the effective standard is still not reached after the rhTPO 300U/kg/d treatment for 14 days. The investigator will assess the changes of the platelet counts after the treatment of Herombopag from week 1 to week 24, and observe incidence of adverse events during the treatment of Herombopag. The investigator will complete the 4 weeks safety visits（once a week），if the subjects end or withdraw from the clinical trial. Patients with chemotherapy-induced thrombocytopenia who had the same inclusion and exclusion criteria in the same period or in the past will be compared with the efficacy and safety of supportive treatment and Eltrombopag or Avatrombopag treatment in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of Herombopag treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-induced Thrombocytopenia, Herombopag

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

50 subjects with chemotherapy-induced thrombocytopenia

Arm Type

Experimental

Arm Description

50 enrolled subjects will be picked up to take Herombopag at the indicated dose.

Intervention Type

Drug

Intervention Name(s)

Herombopag

Intervention Description

The subjects will initiate treatment with 7.5 mg/d Herombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts, and maximum dose should not exceed 7.5 mg daily. Subjects whose platelet count ≤100×109/L，the Herombopag dose will maintain. If platelet count >100×109/L for 2 weeks, the subjects need to reduce the dose of Herombopag to the next lower dose or lower frequency. If subjects whose platelet count exceeds 100×109/L for 4 weeks，already have reduced the dose of Herombopag to 2.5mg once every other day or lower frequency during the treatment period, Herombopag can be stopped for observation, until platelet counts fall below 100×109/L. If the subjects do not need further chemotherapy or radiotherapy, the subjects can taper off Herombopag if the platelet is greater than 50×109/L.

Primary Outcome Measure Information:

Title

Changes of the platelet counts after the treatment of Herombopag at week 12

Description

Time Frame

12 weeks

Title

Changes of the platelet counts after the treatment of Herombopag at week 24

Description

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Incidence of adverse events after the treatment of Herombopag

Description

The investigator will observe incidence of adverse events after the treatment of Herombopag, including thrombosis, diarrhea, skin rash, abnormal liver function and so on.

Time Frame

24 weeks

Title

Changes of concentration of TPO in peripheral blood

Description

The investigator will observe the concentration of TPO in peripheral blood before and after the treatment of Herombopag, if necessary.

Time Frame

24 weeks

Title

Changes of concentration of TPO antibodies，anti-c-Mpl antibodies and TPO neutralizing antibodies in peripheral blood

Description

The investigator will observe the concentration of antibodies in peripheral blood before and after the treatment of Herombopag, if necessary

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged ≥18 years old, male or female; Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT); Ineffective after repeated treatment with rhTPO or IL-11； Stop radiotherapy or chemotherapy for more than 1 month; Platelet counts <30 ×10^9/L, and bleeding tendency; Estimated survival period ≥ 6 months； People who are willing to sign the informed consent voluntarily and follow the research program. Liver and kidney function<1.5×upper limit of normal, qualified for physical examination； Subject is practicing an acceptable method of contraception. Women of childbearing potential must have a negative serum pregnancy test in the whole study; Exclusion Criteria: Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases； Patients with poor compliance; Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA; Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc. There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator； Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis； Those who have received allogeneic stem cell transplantation or organ transplantation in the past； Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up； Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared； Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)； Patients with sepsis or patients with other irregular bleeding； Patients taking antiplatelet drugs at the same time； Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients； Pre-existing cardiac disease, including congestive heart failure of New York Heart Association [NYHA] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT >450msec or QTc > 480 for patients with a Bundle Branch Block; Researchers believe that patients should not participate in the test of any other condition.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yunfei Chen, MD

Phone

+8618502220788

chenyunfei@ihcams.ac.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lei Zhang, MD

Organizational Affiliation

Chinese Academy of Medical Science and Blood Disease Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chinese Academy of Medical Science and Blood Disease Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yunfei Chen, MD

Phone

+86-22-23909009

chenyunfei@ihcams.ac.cn

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.

IPD Sharing Time Frame

12 months to 36 months after study completion.

IPD Sharing Access Criteria

Upon request to PI.

Learn more about this trial

Herombopag for Chemotherapy-induced Thrombocytopenia

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