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

Recruiting Phase 2 Interventional Study
Persistent Isolated Chemotherapy-Induced Thrombocytopenia Chemotherapy-Induced Thrombocytopenia Gynecologic Cancers Ovarian Cancer Breast Cancer Lung Cancer Non-Small Cell Lung Cancer Cervical Cancer Fallopian Tube Cancer Primary Peritoneal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
Peking University People's Hospital · Other
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About This Trial
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 ce…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age 18 years or older. 2. Prior diagnosis of a selected gynecologic, breast, or lung solid tumor, including but not limited to non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer. Other eligible tumor types may include endometrial cancer, cervical cancer, fal…
Contacts

Xiaohui Zhang, MD

+8610-8832-4672

zhangxh@bjmu.edu.cn

CONTACT

Kexin Shen, MD

+8617710635036

keceyshen@gmail.com

CONTACT