CTIT: Cancer Therapy Induced ThrombocytopeniaPhase 3FRIENDS-01NCT06759636
A Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11
A Phase 3 study testing Romiplostim N01 and Recombinant Human Interleukin-11 (rhIL-11) in people with CTIT: Cancer Therapy Induced Thrombocytopenia, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
FRIENDS-01：A Multicenter Open-label Randomized Controlled Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CTIT: Cancer Therapy Induced Thrombocytopenia
- What is being tested?
- Romiplostim N01 and Recombinant Human Interleukin-11 (rhIL-11)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2025to 21 Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Voluntarily participate in this study, sign an informed consent form, and strictly complied with the study protocol requirements；
- 2.Age range from 18 to 75 years old，male or female；
- 3.Diagnosed with a malignant tumor by histopathology and/or cytology and is receiving anti-tumor therapy such as chemotherapy, radiotherapy, immunology, and targeting；
- 4.ECOG PS score: 0-2；
- 5.Developed treatment-induced thrombocytopenia with platelet count between 10×10⁹/L and 75×10⁹/L; if platelet count is between 10×10⁹/L and 50×10⁹/L, one platelet test is required with a 24-hour interval; if platelet count is between 50×10⁹/L and 75×10⁹/L, two platelet tests are required.；
- 6.Estimated survival time during screening is ≥ 12 weeks, and could be treated with current antitumor regimens for at least 1 cycle；
- 7.Subjects of childbearing age agree to take reliable contraceptive measures (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive cream, contraceptive suppository, abstinence and the placement of intrauterine devices, etc.) throughout the study period; Excluding female participants who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or more than 1 year after menopause, as well as male participants who have undergone bilateral salpingectomy or ligation；
- 8.Adequate organ and bone marrow function.
Who cannot join
- 1. Platelet values at screening or baseline were ≤10×10^9/L；
- 2.Participants with a history of any hematological malignancy，including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome；
- 3.Participants had a history of chronic platelet or bleeding disorders，or screening for thrombocytopenia caused by causes other than CIT within the first 6 months, including but not limited to chronic liver disease, splenic hyperfunction, infection, and bleeding；
- 4.Bone marrow invasion or metastasis;
- 5.Have received pelvic and spinal radiation therapy, as well as bone field radiation therapy, or are currently/expected to receive radiation therapy within the three months prior to screening;
- 6.Brain tumors or brain metastases;
Show all 22Show fewer
- 7.Screening for a history of severe cardiovascular disease within the first 6 months, such as congestive heart failure (NYHA heart function score III-IV), known arrhythmias that increase the risk of thromboembolism, such as atrial fibrillation, after coronary stent implantation, angioplasty, and coronary artery bypass grafting;
- 8.Any history of arterial or venous thrombosis occurring within the first 6 months of screening;
- 9.Screening for clinical manifestations of severe bleeding within the first two weeks, such as gastrointestinal or central nervous system bleeding;
- 10.Neutrophil absolute value < 1.0 × 10^9/L, hemoglobin < 80g/L, allowing the use of granulocyte colony-stimulating factors and red blood cells that comply with clinical norms EPO infusion therapy
- 11.Significant abnormalities in liver function: patients without liver metastasis, ALT/AST>3ULN (upper limit of normal value), TBIL>3ULN； Patients with liver metastasis are present, ALT/AST≥5ULN，TBIL≥5ULN;
- 12.Renal dysfunction: blood creatinine ≥ 1.5ULN or eGFR ≤ 60 ml/min (Cockcroft Gault formula);
- 13.Received thrombopoietin receptor agonists, recombinant human thrombopoietin (rhTPO), or recombinant human interleukin-11 (rhIL-11) within 5 half-lives of the drug prior to screening. The maximum washout period calculated based on 5 half-lives of the drugs is: hetrombopag 8.4 days, avatrombopag 4 days, eltrombopag 6.7 days, lusutrombopag 6 days, romiplostim or romiplostim N01 29 days, rhTPO 9.7 days, rhIL-11 1.4 days;
- 14.Received platelet transfusion within the first two weeks of randomization;
- 15.Participants who are known or expected to be allergic or intolerant to Roxetine N01 or rhIL-11 excipients;
- 16.HIV infected individuals;
- 17.Pregnant or lactating women;
- 18.Participants had medically known hereditary prethrombotic syndromes (e.g., clotting factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency);
- 19.Participants were given a vitamin K antagonist within 7 days prior to screening (permitted drugs included low molecular weight heparin, Factor Xa inhibitors, or thrombin inhibitors);
- 20.As assessed by the investigators, the participants had any concomitant medical history that could compromise the participants' safe completion of the study, such as unstable angina, renal failure on hemodialysis, or an active infection requiring intravenous antibiotics;
- 21.Participated in any clinical study of any other investigational drug or device three months prior to screening;
- 22.The researchers believe that participating in the trial poses a significant risk to the health or safety of the subjects, or other circumstances that may affect the efficacy evaluation;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
Xiaofeng Chen, Chief physician, 86+13585172066, xiaofengch198019@126.com
Yongqian Shu, Chief physician
About this study
Official title: FRIENDS-01：A Multicenter Open-label Randomized Controlled Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11
FRIENDS-01：A Multicenter Open-label Randomized Controlled Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11
- Being tested
- Romiplostim N01, Recombinant Human Interleukin-11 (rhIL-11)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Romiplostim N01Drug
3.0 µg/kg, subcutaneous injection, once a week. Afterwards, refer to the platelet count evaluated during the visit before the next dosing cycle: ① If the platelet count is less than 50×10^9/L, increase by 1-2μg/kg once a week; ② If the platelet count is between 50-99×10^9/L, increase by 1μg/kg once a week. According to platelet count and symptoms, investigators can adjust the dosage to the maximum dosage of 10μg/kg once a week.
Recombinant Human Interleukin-11 (rhIL-11)Drug
25-50μg/kg, subcutaneous injection, once a day
| Study group | Role | What they receive |
|---|---|---|
| Romiplostim N01 | Experimental | 3.0 µg/kg, subcutaneous injection, once a week. Afterwards, refer to the platelet count evaluated during the visit before the next dosing cycle: ① If the platelet count is less than 50×10^9/L, increase by 1-2μg/kg once a week; ② If the platelet count is between 50-99×10^9/L, increase by 1μg/kg once a week. According to platelet count and symptoms, investigators can adjust the dosage to the maximum dosage of 10μg/kg once a week. Receives: Drug: Romiplostim N01 |
| Recombinant Human Interleukin-11 | Active comparator | 25-50μg/kg, subcutaneous injection, once a day Receives: Drug: Recombinant Human Interleukin-11 (rhIL-11) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The median number of days when the platelet count reaches 100×10^9/L or the absolute platelet count increases by 50×10^9/L
Measured: through study completion, an average of 5 months
Secondary outcomes (14)
The median number of days for patients with baseline PLT counts less than 50×10^9/L and less than 75×10^9/L to achieve a PLT count of 100×10^9/L
Measured: through study completion, an average of 5 months
The median number of days in which thrombocytopenia increases from Grade 3 or 4 to Grade 1 or 2
Measured: through study completion, an average of 5 months
The average number of days when the platelet count reaches 100×10^9/L or the absolute platelet count increases by 50×10^9/L
Measured: through study completion, an average of 5 months
Proportion of patients with PLT reaching 100×10^9/L or absolute platelet count increase of 50×10^9/L after 1 week of treatment
Measured: Within 1 weeks after receiving treatment
Proportion of patients with PLT reaching 100×10^9/L or absolute platelet count increase of 50×10^9/L after 2 weeks of treatment
Measured: Within 2 weeks after receiving treatment
Proportion of patients with PLT reaching 100×10^9/L or absolute platelet count increase of 50×10^9/L after 3 weeks of treatment
Measured: Within 3 weeks after receiving treatment
Proportion of patients with PLT reaching 100×10^9/L or absolute platelet count increase of 50×10^9/L after 4 weeks of treatment
Measured: Within 4 weeks after receiving treatment
Thrombocytopenia level in X+1 cycle of antitumor therapy
Measured: through study completion, an average of 5 months
Proportion of bleeding patients
Measured: through study completion, an average of 5 months
The incidence of platelet transfusion
Measured: through study completion, an average of 5 months
The absolute increase in platelet count after the medication was discontinued
Measured: through study completion, an average of 5 months
Effect of Romiplostim N01 on hemoglobin and leukocyte
Measured: through study completion, an average of 5 months
Adverse events (evaluated using the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0), laboratory tests, vital signs, electrocardiograms, and physical examinations, etc
Measured: through study completion, an average of 5 months
The incidence and severity of bleeding events ( being evaluated using the WHO Bleeding Scale) should be closely monitored for participants' drug allergies, cardiovascular adverse events, risk of thrombosis, and rhIL-11 related adverse events
Measured: through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start24 Feb 2025
- Primary completion21 Apr 2026 (estimated)
- Study completion21 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTIT: Cancer Therapy Induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759636
- Sponsor's protocol ID
- QLMA-CTIT-IIT-101
- Acronym
- FRIENDS-01
- Status last verified
- May 2025
- First submitted
- 29 Dec 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRIENDS-01：A Multicenter Open-label Randomized Controlled Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11
- ClinicalTrials.gov ID
- NCT06759636
- Acronym / sponsor ID
- FRIENDS-01 / QLMA-CTIT-IIT-101
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 21 Apr 2026 (estimated)
- Study completion
- 21 Jul 2026 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FRIENDS-01：A Multicenter Open-label Randomized Controlled Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Romiplostim N01 | Experimental | Drug: Romiplostim N013.0 µg/kg, subcutaneous injection, once a week. Afterwards, refer to the platelet count evaluated during the visit before the next dosing cycle: ① If the platelet count is less than 50×10^9/L, increase by 1-2μg/kg once a week; ② If the platelet count is between 50-99×10^9/L, increase by 1μg/kg once a week. According to platelet count and symptoms, investigators can adjust the dosage to the maximum dosage of 10μg/kg once a week. |
| Recombinant Human Interleukin-11 | Active comparator | Drug: Recombinant Human Interleukin-11 (rhIL-11)25-50μg/kg, subcutaneous injection, once a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Voluntarily participate in this study, sign an informed consent form, and strictly complied with the study protocol requirements；
- 2.Age range from 18 to 75 years old，male or female；
- 3.Diagnosed with a malignant tumor by histopathology and/or cytology and is receiving anti-tumor therapy such as chemotherapy, radiotherapy, immunology, and targeting；
- 4.ECOG PS score: 0-2；
- 5.Developed treatment-induced thrombocytopenia with platelet count between 10×10⁹/L and 75×10⁹/L; if platelet count is between 10×10⁹/L and 50×10⁹/L, one platelet test is required with a 24-hour interval; if platelet count is between 50×10⁹/L and 75×10⁹/L, two platelet tests are required.；
Key exclusion criteria (22 listed)
- 1. Platelet values at screening or baseline were ≤10×10^9/L；
- 2.Participants with a history of any hematological malignancy，including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome；
- 3.Participants had a history of chronic platelet or bleeding disorders，or screening for thrombocytopenia caused by causes other than CIT within the first 6 months, including but not limited to chronic liver disease, splenic hyperfunction, infection, and bleeding；
- 4.Bone marrow invasion or metastasis;
- 5.Have received pelvic and spinal radiation therapy, as well as bone field radiation therapy, or are currently/expected to receive radiation therapy within the three months prior to screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Romiplostim N013.0 µg/kg, subcutaneous injection, once a week. Afterwards, refer to the platelet count evaluated during the visit before the next dosing cycle: ① If the platelet count is less than 50×10^9/L, increase by 1-2μg/kg once a week; ② If the platelet count is between 50-99×10^9/L, increase by 1μg/kg once a week. According to platelet count and symptoms, investigators can adjust the dosage to the maximum dosage of 10μg/kg once a week. | Drug | Romiplostim N01 |
| Recombinant Human Interleukin-11 (rhIL-11)25-50μg/kg, subcutaneous injection, once a day | Drug | Recombinant Human Interleukin-11 |
Primary outcome
The median number of days when the platelet count reaches 100×10^9/L or the absolute platelet count increases by 50×10^9/L
Time frame: through study completion, an average of 5 months
14 secondary outcomes
The median number of days for patients with baseline PLT counts less than 50×10^9/L and less than 75×10^9/L to achieve a PLT count of 100×10^9/L
Time frame: through study completion, an average of 5 months
The median number of days in which thrombocytopenia increases from Grade 3 or 4 to Grade 1 or 2
Time frame: through study completion, an average of 5 months
The average number of days when the platelet count reaches 100×10^9/L or the absolute platelet count increases by 50×10^9/L
Time frame: through study completion, an average of 5 months
Proportion of patients with PLT reaching 100×10^9/L or absolute platelet count increase of 50×10^9/L after 1 week of treatment
Time frame: Within 1 weeks after receiving treatment
Proportion of patients with PLT reaching 100×10^9/L or absolute platelet count increase of 50×10^9/L after 2 weeks of treatment
Time frame: Within 2 weeks after receiving treatment
Proportion of patients with PLT reaching 100×10^9/L or absolute platelet count increase of 50×10^9/L after 3 weeks of treatment
Time frame: Within 3 weeks after receiving treatment
Proportion of patients with PLT reaching 100×10^9/L or absolute platelet count increase of 50×10^9/L after 4 weeks of treatment
Time frame: Within 4 weeks after receiving treatment
Thrombocytopenia level in X+1 cycle of antitumor therapy
Time frame: through study completion, an average of 5 months
Proportion of bleeding patients
Time frame: through study completion, an average of 5 months
The incidence of platelet transfusion
Time frame: through study completion, an average of 5 months
The absolute increase in platelet count after the medication was discontinued
Time frame: through study completion, an average of 5 months
Effect of Romiplostim N01 on hemoglobin and leukocyte
Time frame: through study completion, an average of 5 months
Adverse events (evaluated using the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0), laboratory tests, vital signs, electrocardiograms, and physical examinations, etc
Time frame: through study completion, an average of 5 months
The incidence and severity of bleeding events ( being evaluated using the WHO Bleeding Scale) should be closely monitored for participants' drug allergies, cardiovascular adverse events, risk of thrombosis, and rhIL-11 related adverse events
Time frame: through study completion, an average of 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for CTIT: Cancer Therapy Induced Thrombocytopenia
Not yet recruitingPhase 2
A Study of Hetrombopag Combined With rhTPO in the Treatment of Cancer Therapy-induced Thrombocytopenia (CTIT) in Solid Tumor Patients.
Cancer Therapy-induced Thrombocytopenia (CTIT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Romiplostim N01 and Recombinant Human Interleukin-11 (rhIL-11) in people with CTIT: Cancer Therapy Induced Thrombocytopenia, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaofeng Chen Xiaofeng Chen, Chief physician (86+13585172066, xiaofengch198019@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The median number of days when the platelet count reaches 100×10^9/L or the absolute platelet count increases by 50×10^9/L (time frame: through study completion, an average of 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.