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

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, wit

Trial Details

NCT ID
NCT07586826
Phase
PHASE2
Sponsor
Peking University People's Hospital
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Romiplostim N01
  • All-trans retinoic acid
Locations (sample)
  • Beijing, China|39.9075,116.39723

Key Eligibility Criteria

  • Age 18 years or older.
  • Prior diagnosis of a selected gynecologic, breast, or lung solid tumor, including but not limited to non-small cell lung cancer (NSCLC), ovarian ca…
  • Complete remission of the underlying tumor after chemotherapy or antitumor treatment, with tumor-related treatment discontinued for at least 12 wee…
  • Persistent isolated chemotherapy-induced thrombocytopenia, defined as platelet count \<30 x 10\^9/L on two peripheral blood tests at least 7 days a…

For full eligibility, visit ClinicalTrials.gov.

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