Actively Recruiting
Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete 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
105 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
This is a prospective, randomized, open-label, active-controlled study to evaluate the efficacy and safety of Romiplostim N01 plus all-trans retinoic acid (ATRA) compared with Romiplostim N01 alone in adults with persistent isolated chemotherapy-induced thrombocytopenia (PICIT) after complete remission of selected gynecologic, breast, or lung solid tumors, including but not limited to non-small cell lung cancer (NSCLC), ovarian cancer, and breast cancer. Eligible participants will be randomized in a 1:1 ratio to receive Romiplostim N01 plus oral ATRA or Romiplostim N01 alone for 12 weeks, with follow-up through Week 24. The primary outcome is the overall platelet response rate at Week 12, defined as platelet count \>50 x 10\^9/L in at least 2 of the last 3 scheduled platelet assessments up to Week 12. Secondary outcomes include sustained response during Weeks 13 to 24, complete and partial response rates, duration of response, time to response, platelet count changes, platelet transfusion requirements, bleeding events, and safety.
CONDITIONS
Official Title
Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors
Who Can Participate
Eligibility Criteria
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, breast cancer, endometrial cancer, cervical cancer, fallopian tube cancer, primary peritoneal cancer, or other lung cancers.
- Complete remission of the tumor after chemotherapy with at least 12 weeks since last treatment, no recurrence or progression, and no need for more tumor therapy.
- Persistent isolated chemotherapy-induced thrombocytopenia with platelet count below 30 x 10^9/L on two tests at least 7 days apart, or platelet count slightly above 30 x 10^9/L requiring platelet transfusion.
- Thrombocytopenia ongoing since last chemotherapy without signs of recovery.
- Preserved red blood cell and neutrophil counts without significant anemia or neutropenia.
- Bone marrow assessment within 1 year after tumor diagnosis shows no tumor infiltration; normal or increased megakaryocyte count.
- No hepatosplenomegaly, portal hypertension, or other causes of platelet redistribution.
- Prior treatment with at least one thrombopoietin receptor agonist or recombinant human thrombopoietin for PICIT without response.
- No prior use of Romiplostim N01.
- Discontinued other platelet-raising medications before enrollment; investigational or off-label treatments stopped at least 1 month prior.
- Ability to understand and sign informed consent and comply with study visits.
- Participants of reproductive potential agree to use effective contraception; females of childbearing potential have negative pregnancy test before enrollment.
You will not qualify if you...
- Other blood diseases affecting blood cell production or causing low platelets, such as aplastic anemia, myelodysplastic syndrome, leukemia, or primary immune thrombocytopenia.
- Active tumor recurrence, progression, bone marrow metastasis, or tumor infiltration in bone marrow.
- Uncontrolled chronic viral infections (hepatitis B, hepatitis C, HIV) or severe active infection within 4 weeks before screening.
- Severe heart, liver, kidney, or other organ dysfunction or serious disease making treatment unsafe.
- Pregnancy or breastfeeding.
- Known severe allergy to Romiplostim, Romiplostim N01, ATRA, or any study drug component.
- Previous Romiplostim treatment causing severe side effects or no benefit.
- Poor compliance, inability to complete treatment or follow-up, psychiatric or psychological conditions affecting understanding or increasing study risk or interfering with results.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China, 100044
Actively Recruiting
Research Team
X
Xiaohui Zhang, MD
CONTACT
K
Kexin Shen, MD
CONTACT
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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