LeukemiaPhase 2NCT07698080
Dexamethasone, Intravenous Injection of Human Immunoglobulin, and Increased Infusion of Mononuclear Cells to Reduce Donor Specific Antibodies in Haploidentical Hematopoietic Stem Cell Transplantation
A Phase 2 study testing Intravenous Immunoglobulin, Dexamethasone and Mononuclear Cells in people with Leukemia and Lymphoma, run by Hematology department of the 920th hospital.
Trial summary
This study tests whether a combination of three treatments - dexamethasone (a steroid), intravenous immunoglobulin (IVIG, a protein that helps the immune system), and an extra dose of donor mononuclear cells - can safely lower harmful antibodies called donor-specific antibodies (DSA) in patients who need a stem cell… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leukemia, Lymphoma, Thalassemia
- What is being tested?
- Intravenous Immunoglobulin, Dexamethasone and Mononuclear Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 3 Jul 2026to 3 Jul 2028
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of benign or malignant hematological diseases (including leukemia, lymphoma, thalassemia, aplastic anemia, myelodysplastic syndromes, etc.) confirmed by NCCN guidelines, and determined by the investigator to require allogeneic hematopoietic stem cell transplantation.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
- Donor-specific antibody (DSA) mean fluorescence intensity (MFI) > 500.
- Age between 18 and 65 years (age limits are also captured separately in the eligibility module).
- Body weight between 40 kg and 100 kg.
- No other suitable donor available (i.e., no DSA-negative related donor or unrelated donor).
Who cannot join
- Patients unsuitable for transplantation or without willingness to undergo transplantation, or diagnosed with non-hematological diseases.
- Estimated life expectancy < 1 month.
- Known allergy to any drug or intervention used in the study regimen.
- Pregnancy, lactation, active severe infection, or severe major organ dysfunction.
- Severe psychiatric or neurological disorders that may affect the ability to provide informed consent and/or to report adverse events or comply with observation.
- Refusal or inability to sign the informed consent form.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dexamethasone, Intravenous Injection of Human Immunoglobulin, and Increased Infusion of Mononuclear Cells to Reduce Donor Specific Antibodies in Haploid Hematopoietic Stem Cell Transplantation: a Prospective, Multicenter Study
This study tests whether a combination of three treatments - dexamethasone (a steroid), intravenous immunoglobulin (IVIG, a protein that helps the immune system), and an extra dose of donor mononuclear cells - can safely lower harmful antibodies called donor-specific antibodies (DSA) in patients who need a stem cell transplant from a half-matched (haploidentical) family donor.
In these transplants, DSA are antibodies made by the patient's own body that attack the donor's stem cells. If DSA levels are high, the transplant is more likely to fail - the donor cells may not "take" (engraft). Currently, there is no single, simple, and reliable way to reduce DSA, and many existing methods have drawbacks.
Read more
Based on the investigators' earlier experience in 11 patients, this three-part approach seemed to work well. All patients successfully engrafted, and DSA levels dropped quickly. Now the study team want to confirm these results in a larger, prospective, multicenter study.
The investigators plan to enroll 60 patients aged 18-65 with blood cancers or other blood disorders who need a haploidentical transplant, have DSA levels above 500 MFI (a measure of antibody strength), and have no other suitable donor available. Participants will receive:
- Dexamethasone (25 mg/m²) for 4 days before transplant,
- IVIG (1 g/kg) one day before transplant,
- Extra mononuclear cells on transplant day - the extra amount depends on how high their DSA level is (low, medium, or high).
The main goal is to see how many patients have primary graft failure (when the donor cells never engraft). The study team will also measure how long it takes for blood counts to recover, rates of graft-versus-host disease, survival, and side effects. All participants will be followed for 1 year.
This study will help the investigators find out whether this combination is a safe, simple, and effective way to improve transplant success for patients with DSA who have no other donor options.
- Conditions
- Leukemia, Lymphoma, Thalassemia, Aplastic Anemia, Myelodysplastic Syndromes
- Being tested
- Intravenous Immunoglobulin, Dexamethasone, Mononuclear Cells
- Medical subject headings
- Leukemia, Lymphoma, Thalassemia, Anemia, Aplastic, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ImmunoglobulinBiological
1 g/kg intravenously on day -1 prior to transplant.
DexamethasoneDrug
25 mg/m² intravenously for 4 days prior to transplant (days -4 to -1).
Mononuclear CellsBiological
Additional donor MNCs infused on day 0. Dose stratified by baseline DSA MFI level: ≤5000: +2±2×10⁸/kg; 5000-10000: +4±2×10⁸/kg; >10000: +6±2×10⁸/kg.
| Study group | Role | What they receive |
|---|---|---|
| Triple Therapy to Reduce DSA in Haploidentical HSCT: A Prospective Multicenter Study | Experimental | Participants receive dexamethasone (25 mg/m² × 4 days) and intravenous immunoglobulin (1 g/kg) prior to haploidentical hematopoietic stem cell transplantation, plus an additional dose of donor mononuclear cells on transplant day. The additional dose is stratified by baseline DSA MFI level: ≤5000: +2±2×10⁸/kg; 5000-10000: +4±2×10⁸/kg; >10000: +6±2×10⁸/kg. Receives: Biological: Intravenous Immunoglobulin; Drug: Dexamethasone; Biological: Mononuclear Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Graft Failure (PGF)
Measured: Day +28 post-transplant
Secondary outcomes (5)
Neutrophil and Platelet Engraftment Time
Measured: Up to 28 days post-transplant
Dynamic Changes in Donor-Specific Antibody (DSA) MFI Levels
Measured: Pre-transplant (day -14 to -1) through day +22 post-transplant
Incidence of Acute and Chronic Graft-Versus-Host Disease
Cumulative incidence of acute GVHD (aGVHD) graded by standard criteria within 100 days post-transplant, and chronic GVHD (cGVHD) graded by NIH consensus criteria from day +100 through 1 year post-transplant.
Measured: Up to 1 year post-transplant
Overall Survival and Disease-Free Survival
Overall survival (OS) defined as time from transplant to death from any cause. Disease-free survival (DFS) defined as time from transplant to relapse, progression, or death from any cause. Estimated using Kaplan-Meier method at 1 year.
Measured: Up to 1 year post-transplant
Incidence of Adverse Events
Incidence of infectious complications (bacterial, viral, fungal), bleeding events, and other treatment-emergent adverse events. Graded according to CTCAE criteria.
Measured: Up to 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start3 Jul 2026 (estimated)
- Primary completion3 Jul 2028 (estimated)
- Study completion3 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hematology department of the 920th hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698080
- Sponsor's protocol ID
- KM-10
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 14 Jul 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone, Intravenous Injection of Human Immunoglobulin, and Increased Infusion of Mononuclear Cells to Reduce Donor Specific Antibodies in Haploid Hematopoietic Stem Cell Transplantation: a Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT07698080
- Acronym / sponsor ID
- KM-10
- Conditions
- Leukemia, Lymphoma, Thalassemia, Aplastic Anemia, Myelodysplastic Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hematology department of the 920th hospitalUniversity, hospital or other
- Study start
- 3 Jul 2026 (estimated)
- Primary completion
- 3 Jul 2028 (estimated)
- Study completion
- 3 Jul 2028 (estimated)
- First posted
- 13 Jul 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 tests whether a combination of three treatments - dexamethasone (a steroid), intravenous immunoglobulin (IVIG, a protein that helps the immune system), and an extra dose of donor mononuclear cells - can safely lower harmful antibodies called donor-specific antibodies (DSA) in patients who need a stem cell transplant from a half-matched (haploidentical) family donor.
In these transplants, DSA are antibodies made by the patient's own body that attack the donor's stem cells. If DSA levels are high, the transplant is more likely to fail - the donor cells may not "take" (engraft). Currently, there is no single, simple, and reliable way to reduce DSA, and many existing methods have drawbacks.
Based on the investigators' earlier experience in 11 patients, this three-part approach seemed to work well. All patients successfully engrafted, and DSA levels dropped quickly. Now the study team want to confirm these results in a larger, prospective, multicenter study.
The investigators plan to enroll 60 patients aged 18-65 with blood cancers or other blood disorders who need a haploidentical transplant, have DSA levels above 500 MFI (a measure of antibody strength), and have no other suitable donor available. Participants will receive:
- Dexamethasone (25 mg/m²) for 4 days before transplant,
- IVIG (1 g/kg) one day before transplant,
- Extra mononuclear cells on transplant day - the extra amount depends on how high their DSA level is (low, medium, or high).
The main goal is to see how many patients have primary graft failure (when the donor cells never engraft). The study team will also measure how long it takes for blood counts to recover, rates of graft-versus-host disease, survival, and side effects. All participants will be followed for 1 year.
This study will help the investigators find out whether this combination is a safe, simple, and effective way to improve transplant success for patients with DSA who have no other donor options.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple Therapy to Reduce DSA in Haploidentical HSCT: A Prospective Multicenter Study | Experimental | Biological: Intravenous Immunoglobulin, Drug: Dexamethasone, Biological: Mononuclear CellsParticipants receive dexamethasone (25 mg/m² × 4 days) and intravenous immunoglobulin (1 g/kg) prior to haploidentical hematopoietic stem cell transplantation, plus an additional dose of donor mononuclear cells on transplant day. The additional dose is stratified by baseline DSA MFI level: ≤5000: +2±2×10⁸/kg; 5000-10000: +4±2×10⁸/kg; >10000: +6±2×10⁸/kg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of benign or malignant hematological diseases (including leukemia, lymphoma, thalassemia, aplastic anemia, myelodysplastic syndromes, etc.) confirmed by NCCN guidelines, and determined by the investigator to require allogeneic hematopoietic stem cell transplantation.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
- Donor-specific antibody (DSA) mean fluorescence intensity (MFI) > 500.
- Age between 18 and 65 years (age limits are also captured separately in the eligibility module).
- Body weight between 40 kg and 100 kg.
Key exclusion criteria (6 listed)
- Patients unsuitable for transplantation or without willingness to undergo transplantation, or diagnosed with non-hematological diseases.
- Estimated life expectancy < 1 month.
- Known allergy to any drug or intervention used in the study regimen.
- Pregnancy, lactation, active severe infection, or severe major organ dysfunction.
- Severe psychiatric or neurological disorders that may affect the ability to provide informed consent and/or to report adverse events or comply with observation.
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 |
|---|---|---|
| Intravenous Immunoglobulin1 g/kg intravenously on day -1 prior to transplant. | Biological | Triple Therapy to Reduce DSA in Haploidentical HSCT: A Prospective Multicenter Study |
| Dexamethasone25 mg/m² intravenously for 4 days prior to transplant (days -4 to -1). | Drug | Triple Therapy to Reduce DSA in Haploidentical HSCT: A Prospective Multicenter Study |
| Mononuclear CellsAdditional donor MNCs infused on day 0. Dose stratified by baseline DSA MFI level: ≤5000: +2±2×10⁸/kg; 5000-10000: +4±2×10⁸/kg; >10000: +6±2×10⁸/kg. | Biological | Triple Therapy to Reduce DSA in Haploidentical HSCT: A Prospective Multicenter Study |
Primary outcome
Primary Graft Failure (PGF)
Time frame: Day +28 post-transplant
5 secondary outcomes
Neutrophil and Platelet Engraftment Time
Time frame: Up to 28 days post-transplant
Dynamic Changes in Donor-Specific Antibody (DSA) MFI Levels
Time frame: Pre-transplant (day -14 to -1) through day +22 post-transplant
Incidence of Acute and Chronic Graft-Versus-Host Disease
Time frame: Up to 1 year post-transplant
Overall Survival and Disease-Free Survival
Time frame: Up to 1 year post-transplant
Incidence of Adverse Events
Time frame: Up to 1 year post-transplant
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 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous Immunoglobulin, Dexamethasone and Mononuclear Cells in people with Leukemia and Lymphoma, run by Hematology department of the 920th hospital.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Sanbin Wang (+8613187424131, sanbin1011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Graft Failure (PGF) (time frame: Day +28 post-transplant). 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 Jul 2026.