Trial · NCT07586826
Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors
NCT07586826, Phase 2, Recruiting, Peking University People's Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors. Trials, record NCT07586826. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07586826
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors
- NCT number
- NCT07586826
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 220 participants, estimated
- Lead sponsor
- Peking University People's Hospital
- Conditions
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
- Interventions
- Romiplostim N01, All-trans retinoic acid
- First posted
- 2026-05-14
- Last updated
- 2026-05-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Platelet Response Rate at Week 12 | From randomization to Week 12 | Percentage of participants with platelet count \>50 x 10\^9/L in at least 2 of the last 3 scheduled platelet assessments up to Week 12. Platelet transfusion or other rescue/supportive treatment will not be counted as a platelet response. |
| Secondary | Sustained Platelet Response Rate During Weeks 13 to 24 | Weeks 13 through 24 | Percentage of participants with platelet count \>50 x 10\^9/L in at least 2 of the last 3 scheduled platelet assessments during Weeks 13 to 24 and without rescue therapy during this period. |
| Secondary | Complete Response Rate | Up to Week 24 | Percentage of participants with platelet count \>=100 x 10\^9/L and no bleeding for at least 2 consecutive weeks. |
| Secondary | Partial Response Rate | Up to Week 24 | Percentage of participants with platelet count \>=30 x 10\^9/L and at least 2 times the baseline platelet count, with no bleeding. |
| Secondary | Duration of Response | From first documented response to Week 24 | Among responders, time from first achievement of platelet response to platelet count \<30 x 10\^9/L or the end of study follow-up. |
| Secondary | Time to Response | From treatment start to Week 24 | Time from treatment start to the first platelet count \>=30 x 10\^9/L. |
| Secondary | Change in Platelet Count Over Time | Baseline; weekly during Weeks 1 to 12; every 2 weeks during Weeks 13 to 24 | Change in peripheral blood platelet count from baseline at scheduled study visits. |
| Secondary | Platelet Transfusion Requirement | From treatment start to Week 24 | Frequency and total amount of platelet transfusions during treatment and follow-up. |
| Secondary | Incidence of Bleeding Events | From treatment start to Week 24 | Percentage of participants with any bleeding event and severity of bleeding events recorded during the study. |
| Secondary | Incidence of Adverse Events and Serious Adverse Events | From first dose to Week 24 | Adverse events and serious adverse events will be recorded and graded according to CTCAE version 5.0 and summarized by treatment arm. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07586826
GET https://conductscience.org/api/trials/v1/NCT07586826/registered