Dexamethasone, Intravenous Injection of Human Immunoglobulin, and Increased Infusion of Mononuclear Cells to Reduce Donor Specific Antibodies in Haploidentical Hematopoietic Stem Cell Transplantation

July 11, 2026 updated by: Hematology department of the 920th hospital

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
  3. Donor-specific antibody (DSA) mean fluorescence intensity (MFI) > 500.
  4. Age between 18 and 65 years (age limits are also captured separately in the eligibility module).
  5. Body weight between 40 kg and 100 kg.
  6. No other suitable donor available (i.e., no DSA-negative related donor or unrelated donor).

Exclusion Criteria:

  1. Patients unsuitable for transplantation or without willingness to undergo transplantation, or diagnosed with non-hematological diseases.
  2. Estimated life expectancy < 1 month.
  3. Known allergy to any drug or intervention used in the study regimen.
  4. Pregnancy, lactation, active severe infection, or severe major organ dysfunction.
  5. Severe psychiatric or neurological disorders that may affect the ability to provide informed consent and/or to report adverse events or comply with observation.
  6. Refusal or inability to sign the informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Triple Therapy to Reduce DSA in Haploidentical HSCT: A Prospective Multicenter Study
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.
Biological: Intravenous Immunoglobulin
1 g/kg intravenously on day -1 prior to transplant.
Drug: Dexamethasone
25 mg/m² intravenously for 4 days prior to transplant (days -4 to -1).
Biological: Mononuclear Cells
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary Graft Failure (PGF)
Time Frame: Day +28 post-transplant
Day +28 post-transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutrophil and Platelet Engraftment Time
Time Frame: Up to 28 days post-transplant
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
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
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.
Up to 1 year post-transplant
Overall Survival and Disease-Free Survival
Time Frame: Up to 1 year post-transplant
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.
Up to 1 year post-transplant
Incidence of Adverse Events
Time Frame: Up to 1 year post-transplant
Incidence of infectious complications (bacterial, viral, fungal), bleeding events, and other treatment-emergent adverse events. Graded according to CTCAE criteria.
Up to 1 year post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hematology department of the 920th hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 3, 2026

Primary Completion (Estimated)

July 3, 2028

Study Completion (Estimated)

July 3, 2028

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 11, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KM-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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