Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-60
SponsorAnhui Provincial Hospital

About this trial

To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Definite diagnosis of malignant hematologic disease before transplantation, age 12-60 years old, gender is not limited, race is not limited;

Patients who are proposed to receive allo-PBSCT for the first time;

Eastern Cooperative Oncology Group (ECOG) score 0-2;

No serious organ failure and active infection;

Disqualifiers

Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;

Pregnant patients;

Patients and/or authorized family members who refuse to undergo an open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation;

Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at unnecessary risk; drug-dependent individuals; patients with uncontrolled psychiatric disorders; and individuals with cognitive dysfunction;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Time of stem cell infusion

    Procedure/Surgery

    Randomization of patients according to the time of stem cell infusion

Treatment groups

198 Participants
are divided into 2 treatment groups
Group A: the early infused groupActive comparator 1 intervention
Group B: the late infused groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

The cumulative incidence of grade II to IV aGVHD

The primary endpoint of the study will be the development of aGVHD in the first 100 days post-transplant. aGVHD was graded according to the Mount Sinai Acute GVHD International Consortium criteria.

Time frame
100 days

Secondary outcomes

1

The cumulative incidence of grade III to IV aGVHD

The cumulative incidence of grade II to IV aGVHD in the first 100 days post-transplant. aGVHD was graded according to the Mount Sinai Acute GVHD International Consortium criteria.

Time frame
100 days
2

The cumulative incidence of neutrophil engraftment at 28 days after transplantation

neutrophil engraftment time was defined as the first of three consecutive days during which the neutrophil count was at least 0.5×10\^9/L.

Time frame
28 days
3

The cumulative incidence of platelet recovery at 100 days after transplantation

Platelet recovery is defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥ 100 × 10\^9/L.

Time frame
100 days
4

The cumulative incidence of transplant-related mortality at 180 days after transplantation

The cumulative incidence of transplant-related mortality at 180 days after transplantation.

Time frame
180 days

Other outcomes

Sponsors and contacts

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