Eltrombopag for Chemotherapy-induced Thrombocytopenia

NCT04600960 | Recruiting Phase 2 DMC

• 1 other identifier: IIT2020014（Eltrombopag）
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of eltrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors

Conditions

Chemotherapy-induced Thrombocytopenia; Eltrombopag

Outcome Measures

Primary Outcomes (2)

• Changes of the platelet counts after the treatment of eltrombopag

  The investigator will assess the changes of the platelet counts after the treatment of eltrombopag from week 1 to week 24.

  24 weeks

• Incidence of adverse events after the treatment of eltrombopag

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

  24 weeks

Secondary Outcomes (4)

• Changes of concentration of TPO in peripheral blood

  24 weeks

• Changes of concentration of TPO antibodies in peripheral blood

  24 weeks

• Changes of concentration of anti-c-Mpl antibodies in peripheral blood

  24 weeks

• Changes of concentration of TPO neutralizing antibodies in peripheral blood

  24 weeks

Study Arms (1)

50 subjects with chemotherapy-induced thrombocytopenia

EXPERIMENTAL

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

Drug: Eltrombopag

Interventions

Eltrombopag DRUG

The subjects will initiate treatment with 75 mg eltrombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts, and maximum dose should not exceed 75 mg daily. Subjects whose platelet count ≤100×109/L，the eltrombopag dose will maintain. If platelet count \>100×109/L for 2 weeks, the subjects need to reduce the dose of eltrombopag 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 eltrombopag to 25mg once every other day during the treatment period, eltrombopag 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 eltrombopag if the platelet is greater than 50×109/L.

50 subjects with chemotherapy-induced thrombocytopenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Tianjin Medical University Second Hospital: collaborator
• Tianjin Third Central Hospital: collaborator
• Tianjin People's Hospital: collaborator
• Henan Cancer Hospital: collaborator
• The Second Affiliated Hospital of Kunming Medical University: collaborator

Study Sites (1)

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

Related Publications (2)

• Winer ES, Safran H, Karaszewska B, Richards DA, Hartner L, Forget F, Ramlau R, Kumar K, Mayer B, Johnson BM, Messam CA, Mostafa Kamel Y. Eltrombopag with gemcitabine-based chemotherapy in patients with advanced solid tumors: a randomized phase I study. Cancer Med. 2015 Jan;4(1):16-26. doi: 10.1002/cam4.326. Epub 2014 Aug 28.

  PMID: 25165041 BACKGROUND

• Winer ES, Safran H, Karaszewska B, Bauer S, Khan D, Doerfel S, Burgess P, Kalambakas S, Mostafa Kamel Y, Forget F. Eltrombopag for thrombocytopenia in patients with advanced solid tumors receiving gemcitabine-based chemotherapy: a randomized, placebo-controlled phase 2 study. Int J Hematol. 2017 Dec;106(6):765-776. doi: 10.1007/s12185-017-2319-9. Epub 2017 Sep 1.

  PMID: 28864871 BACKGROUND

MeSH Terms

Interventions

eltrombopag

Study Officials

• Lei Zhanglei, MD

  Chinese Academy of Medical Science and Blood Disease Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunfei Chen, MD

CONTACT

+86-22-23909009; chenyunfei@ihcams.ac.cn

Lei Zhang, MD

CONTACT

+86-22-23909240; zhanglei1@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: December 31, 2020
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From 12 months 36 months after study completion.
• Access Criteria: Upon request to PI.

Locations

CN (1)