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

Sponsor
Peking University People's Hospital
Study ID
NCT07586826
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Romiplostim N01 — DRUG
    Romiplostim N01 will be administered by subcutaneous injection at an initial dose of 4 mcg/kg once weekly for 12 weeks. The dose may be adjusted according to platelet count: increase by 2 mcg/kg if platelet count is \<50 x 10\^9/L, with a maximum dose of 10 mcg/kg; maintain the current dose if platelet count is \>=50 to \<=200 x 10\^9/L; reduce by 1 mcg/kg if platelet count is \>200 to \<=400 x 10\^9/L; and withhold dosing if platelet count is \>400 x 10\^9/L, then restart at a lower dose after platelet count decreases to approximately 200 x 10\^9/L.
  • All-trans retinoic acid — DRUG
    All-trans retinoic acid (ATRA) will be administered orally at 10 mg twice daily for 12 weeks. Dose interruption, reduction, or discontinuation may be performed for intolerable toxicity or clinically significant adverse events according to the protocol.

Study Details

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.

Key Dates

First listed
May 14, 2026
Start date
Dec 22, 2025
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Romiplostim N01 Plus ATRA
    Participants randomized to this arm will receive Romiplostim N01 by subcutaneous injection once weekly for 12 weeks, with protocol-defined dose adjustment based on platelet count, plus oral all-trans retinoic acid (ATRA) 10 mg twice daily for 12 weeks. Supportive care and rescue treatment, including platelet transfusion when clinically indicated, are permitted according to the protocol.
  • Active Comparator: Romiplostim N01 Alone
    Participants randomized to this arm will receive Romiplostim N01 by subcutaneous injection once weekly for 12 weeks, with protocol-defined dose adjustment based on platelet count. Supportive care and rescue treatment, including platelet transfusion when clinically indicated, are permitted according to the protocol. Participants in this arm will not receive ATRA.

Primary Outcome Measure

Overall Platelet Response Rate at Week 12 [ Time Frame: From randomization to Week 12 ]

Central Contacts

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