Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia

NCT06898983 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Romiplostim N01-002
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the Efficacy and Safety of Romiplostim N01 for the Treatment of Cancer Treatment-Induced Thrombocytopenia (CTIT) in Patients with Leukemia

Conditions

Cancer Treatment-induced Thrombocytopenia (CTIT)

Outcome Measures

Primary Outcomes (1)

• Platelet response at Week 2 (PLT ≥ 50×10⁹/L)

  Proportion of patients achieving a platelet count ≥ 50×10⁹/L at 2 weeks after initiation of treatment.

  2 weeks

Secondary Outcomes (4)

• Early Platelet Response Rate (within 7 days)

  7 days

• Median time to platelet recovery without transfusion

  8 weeks

• Total platelet transfusion during treatment

  8 weeks

• Platelet nadir during treatment

  8 weeks

Other Outcomes (3)

• Incidence of adverse events

  Within 28 days after treatment discontinuation

• Incidence of bleeding events

  Within 28 days after treatment discontinuation

• Survival outcomes

  Within 28 days after treatment discontinuation

Study Arms (1)

Romiplostim N01

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.

Drug: Romiplostim N01

Interventions

Romiplostim N01 DRUG

Romiplostim N01 will be administered via subcutaneous injection once weekly when patients develop 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. Treatment may continue for up to 8 doses.

Romiplostim N01

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Subjects of childbearing potential agree to use reliable methods of contraception throughout the study period (including male or female condoms, contraceptive foam, gel, film, cream, suppository, abstinence, or intrauterine device);
• Patients considered by the investigator to potentially benefit from the study treatment;
• Voluntarily agrees to participate in the clinical trial, is fully informed of the study procedures, and has signed the written informed consent form.

You may not qualify if:

• 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;
• History of severe thrombotic events or known risk factors for thrombosis, or active thromboembolism requiring anticoagulation therapy;
• Severe bleeding within 2 weeks prior to screening (requiring more than 2 units of red blood cell transfusion or a sudden ≥10% drop in hematocrit);
• Use of thrombopoietin receptor agonists (e.g., eltrombopag), recombinant human thrombopoietin (rhTPO), or interleukin-11 (IL-11) within 1 month prior to screening;
• HIV infection;
• Chronic active hepatitis B or hepatitis C infection;
• Presence of severe infection or serious comorbidities involving the heart, liver, lungs, kidneys, nervous system, or metabolic diseases;
• Participation in any investigational drug or device clinical trial within 28 days prior to baseline visit;
• Subjects with cognitive impairment or uncontrolled psychiatric disorders;
• Refusal of the subject and/or legal representative to receive Romiplostim N01 treatment;
• Deemed unsuitable for enrollment by the investigator (e.g., comorbid conditions that may compromise subject safety or anticipated treatment non-adherence due to financial or other constraints).

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

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

Hefei, Anhui, 230036, China

Location

Study Officials

• Xiaoyu Zhu, Ph.D

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyu Zhu, Ph.D

CONTACT

0551-62283347; xiaoyuz@ustc.edu.cn

Aijie Huang, M.D

CONTACT

0551-62283347; huangaijie@mail.ustc.edu.cn

Study Design

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

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 27, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)