Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID07586826

Romiplostim N01 Combined With All-Trans Retinoic Acid Versus Romiplostim N01 Alone for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Remission of Gynecologic, Breast, or Lung Solid Tumors

Led by Peking University People's Hospital · Updated on 2026-05-14

220

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

P

Peking University People's Hospital

Lead Sponsor

P

Peking University Cancer Hospital and Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining Romiplostim N01 with all-trans retinoic acid (ATRA) compared to Romiplostim N01 alone in adults who have persistent isolated chemotherapy-induced thrombocytopenia (PICIT) after complete remission of certain gynecologic, breast, or lung solid tumors. This includes patients with non-small cell lung cancer, ovarian cancer, breast cancer, and other related cancers. The study is a prospective, randomized, open-label, active-controlled trial focusing on improving platelet counts in this patient group. Participants will be randomly assigned to one of two groups. One group will receive Romiplostim N01 subcutaneously once weekly with dose adjustments based on platelet counts, plus oral ATRA twice daily for 12 weeks. The other group will receive Romiplostim N01 alone once weekly with similar dose adjustments for 12 weeks. Supportive care, including platelet transfusions if needed, is allowed. The treatment period lasts 12 weeks, followed by a 12-week follow-up to monitor sustained effects. During the study, participants will have weekly visits from weeks 1 to 12, then visits every two weeks from weeks 13 to 24. Researchers will assess platelet response rates, complete and partial responses, duration and time to response, platelet count changes over time, need for transfusions, bleeding events, and safety outcomes such as adverse and serious adverse events. The primary measurement is the overall platelet response rate at week 12. Safety monitoring includes tracking possible toxicities and risks related to the treatments. Total participation lasts 24 weeks.

CONDITIONS

Brief Title

Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Prior diagnosis of selected gynecologic, breast, or lung solid tumors, including non-small cell lung cancer, ovarian cancer, or breast cancer
  • Complete remission of the underlying tumor after chemotherapy, with no recurrence or progression and no need for further tumor treatment for at least 12 weeks
  • Persistent isolated chemotherapy-induced thrombocytopenia defined by platelet count <30 x 10^9/L on two tests at least 7 days apart, or platelet transfusion dependence
  • Thrombocytopenia persisting since last chemotherapy with no spontaneous recovery trend
  • Generally preserved red blood cell and neutrophil counts without significant anemia or neutropenia
  • Bone marrow assessment within 1 year showing no tumor infiltration and normal or increased megakaryocyte count
  • No hepatosplenomegaly, portal hypertension, or abnormal platelet redistribution
  • Prior unsuccessful treatment with at least one thrombopoietin receptor agonist or recombinant human thrombopoietin for PICIT
  • No prior use of Romiplostim N01
  • Discontinuation of other platelet-raising and investigational drugs before enrollment
  • Ability to understand and sign informed consent and comply with study visits
  • Agreement to use effective contraception if of reproductive potential, with negative pregnancy test for females of childbearing potential
Not Eligible

You will not qualify if you...

  • Other hematologic diseases affecting blood cell production or causing thrombocytopenia, such as aplastic anemia, myelodysplastic syndrome, leukemia, or primary immune thrombocytopenia
  • Active tumor recurrence, progression, or bone marrow metastasis
  • Uncontrolled chronic viral infections like hepatitis B, hepatitis C, or HIV, or active severe infection within 4 weeks before screening
  • Severe dysfunction of heart, liver, kidneys, or other organs, or serious diseases making treatment intolerable
  • Pregnancy or breastfeeding
  • Known severe allergy to Romiplostim, Romiplostim N01, ATRA, or components of study drugs
  • Previous Romiplostim treatment with severe adverse reactions or lack of efficacy
  • Poor compliance, inability to complete treatment or follow-up, psychiatric conditions preventing understanding, or other conditions increasing study risk or affecting results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants receive Romiplostim N01 by subcutaneous injection once weekly for 12 weeks. Participants in the experimental arm also take oral all-trans retinoic acid (ATRA) twice daily for 12 weeks. Dose adjustments and supportive care are provided based on platelet counts and clinical needs.

Weekly visits for 12 weeks

Follow-up

Duration - 12 weeks

Participants are monitored for sustained platelet response, safety, and adverse events following treatment completion.

Visits every 2 weeks for 12 weeks

Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, China, 100044

Actively Recruiting

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Research Team

X

Xiaohui Zhang, MD

K

Kexin Shen, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Valproic acid and all trans retinoic acid differentially induce megakaryopoiesis and platelet-like particle formation from the megakaryoblastic cell line MEG-01.

N Schweinfurth, S Hohmann, M Deuschle...

https://pubmed.ncbi.nlm.nih.gov/20942599

All-trans retinoic acid protects mesenchymal stem cells from immune thrombocytopenia by regulating the complement-interleukin-1β loop.

Xiaolu Zhu, Yanan Wang, Qian Jiang...

https://pubmed.ncbi.nlm.nih.gov/30679324

Carboplatin-Induced Thrombocytopenia through JAK2 Downregulation, S-Phase Cell Cycle Arrest and Apoptosis in Megakaryocytes.

Yi-Hong Wu, Hsing-Yu Chen, Wei-Chin Hong...

https://pubmed.ncbi.nlm.nih.gov/35682967

Avatrombopag for chemotherapy-induced thrombocytopenia in patients with non-haematological malignancies: an international, randomised, double-blind, placebo-controlled, phase 3 trial.

Hanny Al-Samkari, Jaroslaw Kolb-Sielecki, Sufiia Z Safina...

https://pubmed.ncbi.nlm.nih.gov/35240074

A Randomized Controlled Study of rhTPO and rhIL-11 for the Prophylactic Treatment of Chemotherapy-Induced Thrombocytopenia in Non-Small Cell Lung Cancer.

Yunhua Xu, Xia Song, Fangmin Du...

https://pubmed.ncbi.nlm.nih.gov/30588257