ThrombocytopeniaPhase 2NCT07441720
Safety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT)
A Phase 2 study testing umbilical cord blood in people with Thrombocytopenia and Cancer Treatment-induced Thrombocytopenia, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This study is a prospective, single-center, open-label, single-arm clinical trial to assess the safety and efficacy of umbilical cord blood in cancer treatment-induced thrombocytopenia (CTIT) patients. It plans to recruit subjects aged 12 to 75 years old with CTIT. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Thrombocytopenia, Cancer Treatment-induced Thrombocytopenia
- What is being tested?
- umbilical cord blood
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to 30 Dec 2027
- Phase
- Phase 2
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 12 to 75 years at the time of signing the informed consent, regardless of gender.
- Meets the diagnostic criteria for cancer treatment-induced thrombocytopenia (CTIT):Peripheral blood platelet count < 100 × 10⁹/L; Prior definite exposure to a chemotherapy agent (or tumor-targeted therapy, immunotherapy, or other anti-tumor drugs) known to cause thrombocytopenia, with gradual improvement of thrombocytopenia-related symptoms/signs or normalization of platelet count after discontinuation of the offending drug; Presence or absence of bleeding tendency, such as petechiae, purpura, unexplained epistaxis, or even severe organ/tissue hemorrhage;
- No significant hepatic or renal impairment: ALT and AST ≤ 2.5 × upper limit of normal (ULN), serum creatinine (Cr) and blood urea nitrogen (BUN) ≤ 1.25 × ULN;
- Karnofsky Performance Status (KPS) score ≥ 60 (see Appendix 1), Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix 2);
- Estimated life expectancy of more than 3 months.
Who cannot join
- Other causes of thrombocytopenia, in particular exclusion of underlying diseases or comorbidities such as aplastic anemia, acute leukemia, radiation sickness, immune thrombocytopenia (ITP), hypersplenism, or bone marrow infiltration by tumor cells;
- Use of non-anti-tumor medications known to cause thrombocytopenia (including but not limited to sulfonamides and other drugs);
- Pseudothrombocytopenia induced by ethylenediaminetetraacetic acid (EDTA) anticoagulant;
- Uncontrolled malignant tumor, hypertension, or diabetes mellitus;
- Active infection, including but not limited to known HIV positivity, active hepatitis B or C, or syphilis;
- Poor compliance;
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- Known allergy or hypersensitivity to any component of the study intervention (umbilical cord blood or related products);
- Participation in another clinical trial within 1 month prior to enrollment or current participation in another clinical trial;
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this clinical study.
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
Department of Hematology, Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
18658865413, yuanxiaolinhaha@163.com
About this study
This study is a prospective, single-center, open-label, single-arm clinical trial to assess the safety and efficacy of umbilical cord blood in cancer treatment-induced thrombocytopenia (CTIT) patients. It plans to recruit subjects aged 12 to 75 years old with CTIT. The study involves intravenous infusion of umbilical cord blood, with platelet transfusion as supportive therapy if necessary. The trial consists of three phases: screening (baseline assessments and enrollment), treatment (umbilical cord blood infusion), and follow-up (blood routine tests at Days 3, 7, 14, and 28 post-treatment to record platelet counts, first response time, maximum and minimum values, and calculate efficacy rates while observing changes in thrombocytopenia grading). A total of 25 subjects will be enrolled, and they will undergo evaluation for safety and efficacy based on treatment-related adverse events, GVHD incidence, and hematological improvements.
Read the detailed description
Umbilical cord blood infusion involves cord blood-derived hematopoietic stem cells sourced from the Umbilical Cord Blood Hematopoietic Stem Cell Bank, with HLA typing 0-3/10 matched, total nucleated cells (TNC) >1×10^7/kg, and ABO blood type identical to the recipient. Following intravenous infusion, it promotes platelet recovery by providing hematopoietic stem cells, mesenchymal stem cells, endothelial progenitor cells, and growth factors that stimulate bone marrow progenitor cell proliferation in the in vivo environment, thereby elevating platelet levels.
The primary endpoint of this study is:
Treatment efficacy rate: Post-treatment platelet count ≥100×10^9/L, or an increase of ≥50×10^9/L from baseline, or an increase of ≥100% from baseline.
Secondary endpoints include:
Platelet first response time: Time to first platelet count ≥100×10^9/L without platelet transfusion; Maximum and minimum platelet counts; Incidence of bleeding events after initial infusion; Number of platelet transfusions; Changes in thrombocytopenia grading; Treatment-related adverse events; Incidence and grading of graft-versus-host disease (GVHD).
- Being tested
- umbilical cord blood
- Keywords
- Umbilical cord blood, Cancer treatment-induced thrombocytopenia, CTIT
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord bloodOther
Umbilical cord blood will be selected from a public cord blood bank, requiring an HLA match of 0-3/10, a total nucleated cell (TNC) count >1 × 10⁷/kg, and ABO blood type identical to the recipient. The umbilical cord blood will be intravenously infused into the subject within 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Blood for CTIT Treatment | Experimental | Participants receive intravenous infusion of allogeneic umbilical cord blood (HLA matching 0-3/10 loci, total nucleated cells [TNC] >1×10^7/kg, ABO blood type identical/compatible). Infusions are administered 2-4 times as needed based on clinical response. Platelet transfusions are permitted as supportive therapy if required. The intervention aims to promote platelet recovery through hematopoietic stem cells, mesenchymal stem cells, endothelial progenitor cells, and associated growth factors in patients with cancer treatment-induced thrombocytopenia (CTIT). No comparator or control arm is included in this single-arm design. Receives: Other: umbilical cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy rate
Treatment efficacy rate: Post-treatment platelet count ≥100×10^9/L, or an increase of ≥50×10^9/L from baseline, or an increase of ≥100% from baseline.
Measured: 28 days post-infusion
Treatment-related adverse events
Measured: 28 days post-infusion
Secondary outcomes (5)
(1)Platelet first response time and maximum and minimum platelet counts;
Platelet first response time: Time to first platelet count ≥100×10^9/L without platelet transfusion and maximum and minimum platelet counts;
Measured: 28days post-infusion
Incidence of bleeding events after initial infusion;
Measured: 28 days post-infusion
Number of platelet transfusions;
Measured: 28 days post-infusion
Changes in thrombocytopenia grading;
Measured: 28 days post-infusion
Incidence and grading of graft-versus-host disease (GVHD)
Measured: 100 days post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start28 Feb 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Umbilical cord blood infusion involves cord blood-derived hematopoietic stem cells sourced from the Umbilical Cord Blood Hematopoietic Stem Cell Bank, with HLA typing 0-3/10 matched, total nucleated cells (TNC) \>1×10\^7/kg, and ABO blood type identical to the recipient.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TanYamin, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441720
- Sponsor's protocol ID
- IRB-2026-152
- Status last verified
- May 2026
- First submitted
- 23 Feb 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT)
- ClinicalTrials.gov ID
- NCT07441720
- Acronym / sponsor ID
- IRB-2026-152
- Keywords
- Umbilical cord blood, Cancer treatment-induced thrombocytopenia, CTIT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 2 Mar 2026 (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.
This study is a prospective, single-center, open-label, single-arm clinical trial to assess the safety and efficacy of umbilical cord blood in cancer treatment-induced thrombocytopenia (CTIT) patients. It plans to recruit subjects aged 12 to 75 years old with CTIT. The study involves intravenous infusion of umbilical cord blood, with platelet transfusion as supportive therapy if necessary. The trial consists of three phases: screening (baseline assessments and enrollment), treatment (umbilical cord blood infusion), and follow-up (blood routine tests at Days 3, 7, 14, and 28 post-treatment to record platelet counts, first response time, maximum and minimum values, and calculate efficacy rates while observing changes in thrombocytopenia grading). A total of 25 subjects will be enrolled, and they will undergo evaluation for safety and efficacy based on treatment-related adverse events, GVHD incidence, and hematological improvements.
Detailed description
Umbilical cord blood infusion involves cord blood-derived hematopoietic stem cells sourced from the Umbilical Cord Blood Hematopoietic Stem Cell Bank, with HLA typing 0-3/10 matched, total nucleated cells (TNC) >1×10^7/kg, and ABO blood type identical to the recipient. Following intravenous infusion, it promotes platelet recovery by providing hematopoietic stem cells, mesenchymal stem cells, endothelial progenitor cells, and growth factors that stimulate bone marrow progenitor cell proliferation in the in vivo environment, thereby elevating platelet levels.
The primary endpoint of this study is:
Treatment efficacy rate: Post-treatment platelet count ≥100×10^9/L, or an increase of ≥50×10^9/L from baseline, or an increase of ≥100% from baseline.
Secondary endpoints include:
Platelet first response time: Time to first platelet count ≥100×10^9/L without platelet transfusion; Maximum and minimum platelet counts; Incidence of bleeding events after initial infusion; Number of platelet transfusions; Changes in thrombocytopenia grading; Treatment-related adverse events; Incidence and grading of graft-versus-host disease (GVHD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Umbilical cord blood infusion involves cord blood-derived hematopoietic stem cells sourced from the Umbilical Cord Blood Hematopoietic Stem Cell Bank, with HLA typing 0-3/10 matched, total nucleated cells (TNC) >1×10^7/kg, and ABO blood type identical to the recipient.
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Blood for CTIT Treatment | Experimental | Other: umbilical cord bloodParticipants receive intravenous infusion of allogeneic umbilical cord blood (HLA matching 0-3/10 loci, total nucleated cells [TNC] >1×10^7/kg, ABO blood type identical/compatible). Infusions are administered 2-4 times as needed based on clinical response. Platelet transfusions are permitted as supportive therapy if required. The intervention aims to promote platelet recovery through hematopoietic stem cells, mesenchymal stem cells, endothelial progenitor cells, and associated growth factors in patients with cancer treatment-induced thrombocytopenia (CTIT). No comparator or control arm is included in this single-arm design. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 12 to 75 years at the time of signing the informed consent, regardless of gender.
- Meets the diagnostic criteria for cancer treatment-induced thrombocytopenia (CTIT):Peripheral blood platelet count < 100 × 10⁹/L; Prior definite exposure to a chemotherapy agent (or tumor-targeted therapy, immunotherapy, or other anti-tumor drugs) known to cause thrombocytopenia, with gradual improvement of thrombocytopenia-related symptoms/signs or normalization of platelet count after discontinuation of the offending drug; Presence or absence of bleeding tendency, such as petechiae, purpura, unexplained epistaxis, or even severe organ/tissue hemorrhage;
- No significant hepatic or renal impairment: ALT and AST ≤ 2.5 × upper limit of normal (ULN), serum creatinine (Cr) and blood urea nitrogen (BUN) ≤ 1.25 × ULN;
- Karnofsky Performance Status (KPS) score ≥ 60 (see Appendix 1), Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix 2);
- Estimated life expectancy of more than 3 months.
Key exclusion criteria (9 listed)
- Other causes of thrombocytopenia, in particular exclusion of underlying diseases or comorbidities such as aplastic anemia, acute leukemia, radiation sickness, immune thrombocytopenia (ITP), hypersplenism, or bone marrow infiltration by tumor cells;
- Use of non-anti-tumor medications known to cause thrombocytopenia (including but not limited to sulfonamides and other drugs);
- Pseudothrombocytopenia induced by ethylenediaminetetraacetic acid (EDTA) anticoagulant;
- Uncontrolled malignant tumor, hypertension, or diabetes mellitus;
- Active infection, including but not limited to known HIV positivity, active hepatitis B or C, or syphilis;
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 |
|---|---|---|
| umbilical cord bloodUmbilical cord blood will be selected from a public cord blood bank, requiring an HLA match of 0-3/10, a total nucleated cell (TNC) count >1 × 10⁷/kg, and ABO blood type identical to the recipient. The umbilical cord blood will be intravenously infused into the subject within 30 minutes. | Other | Umbilical Cord Blood for CTIT Treatment |
Primary outcome
Treatment efficacy rate
Time frame: 28 days post-infusion
Treatment efficacy rate: Post-treatment platelet count ≥100×10^9/L, or an increase of ≥50×10^9/L from baseline, or an increase of ≥100% from baseline.
Treatment-related adverse events
Time frame: 28 days post-infusion
5 secondary outcomes
(1)Platelet first response time and maximum and minimum platelet counts;
Time frame: 28days post-infusion
Incidence of bleeding events after initial infusion;
Time frame: 28 days post-infusion
Number of platelet transfusions;
Time frame: 28 days post-infusion
Changes in thrombocytopenia grading;
Time frame: 28 days post-infusion
Incidence and grading of graft-versus-host disease (GVHD)
Time frame: 100 days post-infusion
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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 2 study testing umbilical cord blood in people with Thrombocytopenia and Cancer Treatment-induced Thrombocytopenia, run by Zhejiang Cancer Hospital 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 5 inclusion and 9 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 13 Oct 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiaolin Yuan (+86 057188122153, yuanxiaolinhaha@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy rate (time frame: 28 days post-infusion). The study lists 2 primary outcomes in all. 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 13 Oct 2026.