Chemotherapy-induced thrombocytopenia: literature review.
Ai Gao, Linlin Zhang, Diansheng Zhong
https://pubmed.ncbi.nlm.nih.gov/36695938Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID07586813
Romiplostim N01 Combined With All-Trans Retinoic Acid Versus Romiplostim N01 Alone for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal 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 using Romiplostim N01 alone in adults who have persistent isolated chemotherapy-induced thrombocytopenia (PICIT) after achieving complete remission from gastrointestinal or digestive system solid tumors, including cancers of the gastrointestinal tract, pancreas, and colon or rectum. This Phase 2, prospective, randomized, open-label study aims to address the ongoing low platelet counts that occur despite remission and treatment completion. Eligible participants will be randomly assigned in equal numbers to one of two groups for 12 weeks: one group will receive Romiplostim N01 by weekly subcutaneous injection plus oral ATRA twice daily, while the other group will receive Romiplostim N01 alone by weekly injection. The Romiplostim N01 dose may be adjusted based on platelet counts following the study protocol. Supportive care, including platelet transfusions if needed for severe bleeding or low platelet counts, is allowed. After the treatment period, participants will be followed for an additional 12 weeks. Participants will have weekly visits during the first 12 weeks and biweekly visits from weeks 13 to 24 for assessments. Researchers will monitor platelet response rates at week 12 as the primary outcome, along with sustained platelet responses, complete and partial response rates, response duration, time to response, changes in platelet counts, transfusion needs, bleeding events, and safety concerns including adverse events and thromboembolic risks. The total participation lasts 24 weeks with close safety monitoring throughout.
CONDITIONS
Brief Title
Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Prior diagnosis of gastrointestinal, pancreatic, colorectal, or other digestive system solid tumors
- Complete remission of the tumor after chemotherapy with no recurrence or progression, and no tumor treatment for at least 12 weeks
- Persistent isolated chemotherapy-induced thrombocytopenia with platelet count below 30 x 10^9/L on two tests at least 7 days apart, or platelet transfusion dependence
- Thrombocytopenia persisting since last chemotherapy without spontaneous recovery
- 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 evidence of abnormal platelet redistribution such as hepatosplenomegaly or portal hypertension
- Prior treatment with thrombopoietin receptor agonist or recombinant human thrombopoietin without response
- No prior use of Romiplostim N01
- Other platelet-raising medications discontinued before enrollment; investigational drugs or off-label treatments stopped for at least 1 month
- Ability to understand and sign informed consent and comply with study visits
- Women of childbearing potential must have a negative pregnancy test and agree to effective contraception during treatment
You will not qualify if you...
- Other blood diseases affecting blood cell production or causing thrombocytopenia, including aplastic anemia, myelodysplastic syndrome, leukemia, or primary immune thrombocytopenia
- Active tumor recurrence, progression, bone marrow metastasis, or tumor infiltration
- Uncontrolled chronic viral infection such as hepatitis B, hepatitis C, or HIV, or severe active infection within 4 weeks before screening
- Severe heart, liver, kidney, or other organ dysfunction or serious disease preventing study treatment
- Pregnancy or breastfeeding
- Known severe allergy to Romiplostim, Romiplostim N01, ATRA, or study drug components
- Prior Romiplostim treatment with severe adverse reactions or lack of effectiveness
- Poor compliance or inability to complete treatment or follow-up
- Psychiatric or psychological conditions preventing understanding of the study
- Any condition increasing study risk or interfering with results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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 of Romiplostim N01 are based on platelet count. Supportive care and rescue treatments are permitted as needed.
Weekly visits for 12 weeks
Follow-up
Duration - 12 weeks
Participants are monitored for sustained platelet response, adverse events, and other outcomes every 2 weeks after treatment ends.
Biweekly visits 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
All-trans retinoic acid added to treatment of primary immune thrombocytopenia: a systematic review and meta-analysis.
Jinjun Yang, Lei Zhao, Wen Wang...
https://pubmed.ncbi.nlm.nih.gov/37166528Refractory primary immune thrombocytopenia (ITP): current clinical challenges and therapeutic perspectives.
Nicola Vianelli, Giuseppe Auteri, Francesco Buccisano...
https://pubmed.ncbi.nlm.nih.gov/35201417Romiplostim in chemotherapy-induced thrombocytopenia: A review of the literature.
Gerald A Soff, Hanny Al-Samkari, Avi Leader...
https://pubmed.ncbi.nlm.nih.gov/39135303Treatment of chemotherapy-induced thrombocytopenia in patients with non-hematologic malignancies.
David J Kuter
https://pubmed.ncbi.nlm.nih.gov/35642485