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Romiplostim for Thrombocytopenia in Leukemia Patients

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What is being tested

Romiplostim N01

Drug
Who is being recruted

From 18 to 75 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2025
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Summary

Principal SponsorAnhui Provincial Hospital
Study ContactXiaoyu Zhu, Ph.DMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 31, 2025

Actual date on which the first participant was enrolled.

This clinical trial investigates the use of Romiplostim for treating cancer treatment-induced thrombocytopenia (CTIT) in adults with leukemia. CTIT is a condition where platelet levels drop due to cancer treatments, increasing the risk of bleeding and potentially limiting treatment options. Current management includes platelet transfusions and thrombopoietic agents, but there is limited research on Romiplostim's effectiveness in leukemia patients. By studying this medication, researchers hope to find new ways to manage CTIT, improve treatment outcomes, and enhance the quality of life for patients undergoing cancer therapy. In this phase 2 interventional study, participants receive Romiplostim to assess its effectiveness and safety in increasing platelet counts and reducing bleeding risks. Participants are closely monitored to evaluate how well the drug works in preventing the need for platelet transfusions and managing CTIT. The study focuses on understanding the benefits and any potential side effects of Romiplostim, aiming to establish it as a viable treatment option for leukemia patients experiencing low platelet counts due to cancer treatments.

Official TitleEfficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia
NCT06898983
Principal SponsorAnhui Provincial Hospital
Study ContactXiaoyu Zhu, Ph.DMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

97 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate
Age between 18 and 75 years, inclusive, regardless of sex;

Histologically or pathologically confirmed diagnosis of leukemia;

Patients with cancer treatment-induced thrombocytopenia (CTIT) in patients with leukemia due to antitumor therapy, with platelet count < 50×10⁹/L;

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;

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14 exclusion criteria prevent from participating
Pregnant or breastfeeding women;

Known hypersensitivity to Romiplostim N01;

Presence of hematologic disorders other than cancer treatment-induced thrombocytopenia (CTIT) caused by leukemia treatment, including but not limited to primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, or myelodysplastic syndromes;

History of thrombocytopenia due to causes other than CTIT within 6 months prior to screening, including but not limited to chronic liver disease, hypersplenism, infections, or bleeding disorders;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Romiplostim N01 will be administered once weekly via subcutaneous injection upon the occurrence of Grade 3 thrombocytopenia (platelet count \< 50×10⁹/L) following leukemia treatment. The recommended initial dose is 5 µg/kg, with a maximum single dose not exceeding 250 µg. A maximum of 8 doses may be administered during the treatment period.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, ChinaOpen The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) in Google Maps
Recruiting soonOne Study Center