Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT

NCT06693791 | Recruiting Phase 2 DMC

• 1 other identifier: Romiplostim N01-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of Romiplostim N01 for platelet recovery after umbilical cord blood transplantation (UCBT) in patients with hematological malignancies.

Conditions

Platelet Recovery After Umbilical Cord Blood Transplantation

Outcome Measures

Primary Outcomes (2)

• Time of platelet engraftment

  Platelet engraftment is defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥20 × 10\^9/L.

  28 days

• The cumulative incidence of platelet engraftment at 28 days after transplantation

  Platelet engraftment is defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥20 × 10\^9/L.

  28 days

Secondary Outcomes (5)

• The cumulative incidence of platelet recovery rate at 28 days after transplantation

  28 days

• Time of platelet recovery

  28 days

• Total platelet transfusion during 4 weeks of treatment

  28 days

• Cumulative implantation rate of the granulocyte lineage at 28 days post-transplantation

  28 days

• Megakaryocyte levels in bone marrow smears 4 weeks after treatment

  4 weeks

Study Arms (1)

Romiplostim N01

EXPERIMENTAL

Drug: Romiplostim N01

Interventions

Romiplostim N01 DRUG

Romiplostim N01 was administered subcutaneously once weekly from +1 day to +28 days after UCBT at a recommended starting dose of 5µg/Kg (maximum single dose not to exceed 250µg) for a total of 4 administrations, with the option of continuation of dosing/switching/discontinuing after +28 days, depending on the patient's platelet profile.

Romiplostim N01

Eligibility Criteria

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

You may qualify if:

• Age ≥12 years old, male or female;
• Patients diagnosed with hematological malignancies and undergoing UCBT;
• ECOG score ≤2;
• Voluntary participation in this clinical trial, patients fully understand the trial content and sign the informed consent

You may not qualify if:

• Pregnant or lactating women；
• Known allergy to Romiplostim N01;
• A history of severe thrombotic events or known risk factors for thrombosis or active thromboembolism requiring anticoagulation;
• A history of platelet dysfunction or bleeding prone disease or severe bleeding (requiring more than 2 units of red blood cell infusion or a hematocrit drop of ≥10%) within 7 days prior to screening;
• Chronic active hepatitis B and C;
• Repeat or multiple transplantation or multiple organ transplantation;
• HIV positive, EBV-DNA positive, CMV-DNA positive;
• Have severe infection or complicated with serious heart, liver, lung, kidney, neurological or metabolic diseases;
• A serious adverse event (Level 4 or 5) as defined by the Standard General Terminology for Adverse Events Version 4.0 occurred during the pre-treatment period;
• Participants participate in another clinical study with any exploratory drug or device within 30 days prior to baseline visit; Observational studies are allowed;
• Subjects with cognitive impairment or uncontrolled mental illness;
• Subjects and/or authorized family members to refuse treatment with Romiplostim N01;

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

RECRUITING

Central Study Contacts

Xiaoyu Zhu, ph.D

CONTACT

15255456091; xiaoyuz@ustc.edu.cn

Wanjie Wang, M.D

CONTACT

18855195535; wangwanjie113@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: PRINCIPAL INVESTIGATOR
• PI Title: ph.D

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)