Relapsed LeukemiaPhase 1NCT07297173
Phase 1 Study of Chemotherapy Plus HLA-mismatched GPBMC Infusion Bridging to Allo-HSCT for R/R Leukemia
A Phase 1 study testing Chemotherapy, HLA-mismatched GPBMC infusion and Allogeneic Stem Cell Transplantation in people with Relapsed Leukemia and Refractory Leukemia, run by Beijing 302 Hospital at 1 site in China.
Trial summary
This is a Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of chemotherapy combining with HLA-mismatched G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion as a bridging therapy to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Relapsed Leukemia, Refractory Leukemia
- What is being tested?
- Chemotherapy, HLA-mismatched GPBMC infusion and Allogeneic Stem Cell Transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Dec 2030
- Phase
- Phase 1
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >=15 years, male or female, non-limited by race or ethnicity.
- Confirmed diagnosis of R/R leukemia and risk stratification according to the World Health Organization (WHO) 5th edition classification, based on histopathology and cytogenetics.
- Adequate hepatic function including alanine transaminase (ALT) and aspartate aminotransferase (AST )<= 3 × upper limit of normal(ULN), and total bilirubin <= 1.5 × ULN.
- Adequate renal function including serum creatinine <= 2 × ULN or CrCl>= 40mL/min.
- LVEF measured by echocardiogram is within the normal range (LVEF > 50%).
- The subject must have one HLA mismatched donor who is >= 18 years old to provide GPBMCs for the first-step infusion. If this donor is not qualified as an allo-HSCT donor, the subject must also have another donor who is >= 18 years old and qualified as allo-HSCT donor (i.e., matched sibling, 9-10/10 loci matched unrelated, or haploidentical). In addition, the donor voluntarily donates hematopoietic stem cells and signs the consent form. Each subject (or his/her legal representatives) must sign the Informed Consent Form (ICF), indicating that he/she understands the purpose and procedures of research, and is willing to participate in research.
- Donor inclusion criteria: The donor meets the institution's criteria for related peripheral blood hematopoietic stem cell donors. The donor must be able to tolerate the cell separation and collection process, and sign the Informed Consent Form.
Who cannot join
- Uncontrolled infection or hemorrhage.
- Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease.
- Uncontrolled autoimmune disease or requiring immunosuppression treatment.
- History of severe blood infusion reaction.
- Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception.
- Psychiatric disorder or cognitive impairment that in the researcher's judgment would make the subject not likely to adhere to the protocol requirements.
- Major surgery within 4 weeks prior to enrollment.
- Life-threatening illness other than leukemia or uncontrolled intercurrent illness.
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, the Fifth Medical Center of Chinese PLA General Hospital
Beijing, 100071
Bo Cai, MD, +861066947168, caibo2008@163.com
Yangyang Lei, MD, +861066947180, 942056176@qq.com
About this study
Official title: Phase 1 Study of Chemotherapy Combining With HLA-mismatched G-CSF Mobilized Peripheral Blood Mononuclear Cell Infusion as a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed and Refractory Leukemia
This is a Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of chemotherapy combining with HLA-mismatched G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion as a bridging therapy to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with relapsed and refractory (R/R) leukemia.
Read the detailed description
Eligible patients will firstly receive chemotherapy combining with infusion of HLA-mismatched GPBMCs with the aim to reduce leukemia burden. Secondly, they will receive allo-HSCT per protocol. GPBMCs used in the first-step infusion will be derived from a sibling or unrelated donor, and GPBMCs used in the allo-HSCT procedure will be derived from an alternative donor, or the same donor (haploidentical/matched sibling/HLA 9-10 loci matched unrelated) as in the first step. The primary endpoint is the incidence of treatment-related adverse events (AEs) within 100 days post allo-HSCT, including graft-versus-host disease (GVHD), infection, organ dysfunction, and hematological toxicity. Secondary endpoints include overall survival (OS) at 1 and 2 years, progression-free survival (PFS), and graft-versus-host disease-free, relapse-free survival (GRFS).
- Conditions
- Relapsed Leukemia, Refractory Leukemia
- Being tested
- Chemotherapy, HLA-mismatched GPBMC infusion, Allogeneic Stem Cell Transplantation
- Keywords
- HLA-mismatched GPBMC, allo-HSCT, relapsed leukemia, refractory leukemia
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyProcedure or surgery
Available chemotherapy regimens include but not limited to FLAG (fludarabine, cytarabine, G-CSF), DAV (daunorubicin, cytarabine, venetoclax), IAV (idarubicin, cytarabine, venetoclax), VDCP (vincristine, daunorubicin, cyclophosphamide, prednisone), hyper-CVAD A (cyclophosphamide, vincristine, doxorubicin, dexamethasone), FC (fludarabine and cyclophosphamide), et al.
HLA-mismatched GPBMC infusionBiological
HLA-mismatched GPBMCs are infused following chemotherapy.
Allogeneic Stem Cell TransplantationProcedure or surgery
Patients receive conditioning including but not limited to fludarabine, cyclophosphamide, antithymocyte globulin (ATG), and total body irradiation (TBI). HLA-matched sibling/haploidentical/unrelated GPBMCs are infused at day 0. Post-transplant cyclophosphamide, tacrolimus/cyclosporin, and mycophenolate mofetil are administered as graft-versus-host disease prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | This cohort includes patients with relapsed and refractory leukemia. Patients firstly receive chemotherapy per center standard, followed by HLA-mismatched GPBMC infusion. Secondly, patients receive HLA-matched sibling/haploidentical/unrelated HSCT. Receives: Procedure: Chemotherapy; Biological: HLA-mismatched GPBMC infusion; Procedure: Allogeneic Stem Cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft-Versus-Host Disease (GVHD)
Including acute GVHD (aGVHD) and chronic GVHD (cGVHD), assessed per international universal criteria (e.g., Glucksberg classification).
Measured: Measured up to 2 years after the last participant is enrolled
Infections
Covering bacterial, viral, fungal infections (e.g., pneumonia, sepsis, cytomegalovirus infection), confirmed based on clinical symptoms, laboratory tests, and etiological evidence.
Measured: Measured up to 2 years after the last participant is enrolled
Hematological Toxicity
Including neutropenia, thrombocytopenia, anemia, etc., graded according to the Common Terminology Criteria for Adverse Events (CTCAE) standards.
Measured: Measured up to 2 years after the last participant is enrolled
Secondary outcomes (4)
Progression-Free Survival (PFS)
Time from the completion of allo-HSCT to disease progression, relapse, or death from any cause.
Measured: Measured up to 4 years after the last participant is enrolled
Graft-Versus-Host Disease-Free, Relapse-Free Survival (GRFS)
Time from the completion of allo-HSCT to the first occurrence of any of the following events: grade 3-4 acute GVHD, chronic GVHD requiring systemic treatment, disease relapse, or death.
Measured: Measured up to 4 years after the last participant is enrolled
Overall Survival (OS)
Time from the completion of allo-HSCT to death from any cause.
Measured: Measured up to 4 years after the last participant is enrolled
Treatment-Related Mortality (TRM)
TRM is defined as the death related to treatment instead of disease progression.
Measured: Measured up to 2 years after the last participant is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Dec 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed LeukemiaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bo Cai, MD, Principal investigator, Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297173
- Sponsor's protocol ID
- Allo-GPBMC to Allo-HSCT
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Chemotherapy Combining With HLA-mismatched G-CSF Mobilized Peripheral Blood Mononuclear Cell Infusion as a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed and Refractory Leukemia
- ClinicalTrials.gov ID
- NCT07297173
- Acronym / sponsor ID
- Allo-GPBMC to Allo-HSCT
- Conditions
- Relapsed Leukemia, Refractory Leukemia
- Keywords
- HLA-mismatched GPBMC, allo-HSCT, relapsed leukemia, refractory leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 22 Dec 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.
This is a Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of chemotherapy combining with HLA-mismatched G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion as a bridging therapy to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with relapsed and refractory (R/R) leukemia.
Detailed description
Eligible patients will firstly receive chemotherapy combining with infusion of HLA-mismatched GPBMCs with the aim to reduce leukemia burden. Secondly, they will receive allo-HSCT per protocol. GPBMCs used in the first-step infusion will be derived from a sibling or unrelated donor, and GPBMCs used in the allo-HSCT procedure will be derived from an alternative donor, or the same donor (haploidentical/matched sibling/HLA 9-10 loci matched unrelated) as in the first step. The primary endpoint is the incidence of treatment-related adverse events (AEs) within 100 days post allo-HSCT, including graft-versus-host disease (GVHD), infection, organ dysfunction, and hematological toxicity. Secondary endpoints include overall survival (OS) at 1 and 2 years, progression-free survival (PFS), and graft-versus-host disease-free, relapse-free survival (GRFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Procedure: Chemotherapy, Biological: HLA-mismatched GPBMC infusion, Procedure: Allogeneic Stem Cell TransplantationThis cohort includes patients with relapsed and refractory leukemia. Patients firstly receive chemotherapy per center standard, followed by HLA-mismatched GPBMC infusion. Secondly, patients receive HLA-matched sibling/haploidentical/unrelated HSCT. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age >=15 years, male or female, non-limited by race or ethnicity.
- Confirmed diagnosis of R/R leukemia and risk stratification according to the World Health Organization (WHO) 5th edition classification, based on histopathology and cytogenetics.
- Adequate hepatic function including alanine transaminase (ALT) and aspartate aminotransferase (AST )<= 3 × upper limit of normal(ULN), and total bilirubin <= 1.5 × ULN.
- Adequate renal function including serum creatinine <= 2 × ULN or CrCl>= 40mL/min.
- LVEF measured by echocardiogram is within the normal range (LVEF > 50%).
Key exclusion criteria (8 listed)
- Uncontrolled infection or hemorrhage.
- Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease.
- Uncontrolled autoimmune disease or requiring immunosuppression treatment.
- History of severe blood infusion reaction.
- Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception.
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 |
|---|---|---|
| ChemotherapyAvailable chemotherapy regimens include but not limited to FLAG (fludarabine, cytarabine, G-CSF), DAV (daunorubicin, cytarabine, venetoclax), IAV (idarubicin, cytarabine, venetoclax), VDCP (vincristine, daunorubicin, cyclophosphamide, prednisone), hyper-CVAD A (cyclophosphamide, vincristine, doxorubicin, dexamethasone), FC (fludarabine and cyclophosphamide), et al. | Procedure or surgery | Cohort 1 |
| HLA-mismatched GPBMC infusionHLA-mismatched GPBMCs are infused following chemotherapy. | Biological | Cohort 1 |
| Allogeneic Stem Cell TransplantationPatients receive conditioning including but not limited to fludarabine, cyclophosphamide, antithymocyte globulin (ATG), and total body irradiation (TBI). HLA-matched sibling/haploidentical/unrelated GPBMCs are infused at day 0. Post-transplant cyclophosphamide, tacrolimus/cyclosporin, and mycophenolate mofetil are administered as graft-versus-host disease prophylaxis. | Procedure or surgery | Cohort 1 |
Primary outcome
Graft-Versus-Host Disease (GVHD)
Time frame: Measured up to 2 years after the last participant is enrolled
Including acute GVHD (aGVHD) and chronic GVHD (cGVHD), assessed per international universal criteria (e.g., Glucksberg classification).
Infections
Time frame: Measured up to 2 years after the last participant is enrolled
Covering bacterial, viral, fungal infections (e.g., pneumonia, sepsis, cytomegalovirus infection), confirmed based on clinical symptoms, laboratory tests, and etiological evidence.
Hematological Toxicity
Time frame: Measured up to 2 years after the last participant is enrolled
Including neutropenia, thrombocytopenia, anemia, etc., graded according to the Common Terminology Criteria for Adverse Events (CTCAE) standards.
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Measured up to 4 years after the last participant is enrolled
Graft-Versus-Host Disease-Free, Relapse-Free Survival (GRFS)
Time frame: Measured up to 4 years after the last participant is enrolled
Overall Survival (OS)
Time frame: Measured up to 4 years after the last participant is enrolled
Treatment-Related Mortality (TRM)
Time frame: Measured up to 2 years after the last participant is enrolled
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 22 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Bo Cai, MD principal investigator
Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chemotherapy, HLA-mismatched GPBMC infusion and Allogeneic Stem Cell Transplantation in people with Relapsed Leukemia and Refractory Leukemia, run by Beijing 302 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 7 inclusion and 8 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 22 Dec 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Bo Cai, MD (+861066947168, caibo2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft-Versus-Host Disease (GVHD) (time frame: Measured up to 2 years after the last participant is enrolled). The study lists 3 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 22 Dec 2025.