Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies Post UCBT

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
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 malignant hematologic diseases after single-unit unrelated cord blood transplantation (sUCBT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Definite diagnosis of malignant hematologic disease before transplantation, age, gender and race are not limited;

Participants were required to have achieved complete remission with negative minimal residual disease (MRD) prior to transplantation;

Participants who are proposed to receive sUCBT for the first time;

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

Disqualifiers

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

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

Participants in other clinical studies that may affect aGVHD within 3 months;

Those whom the investigator considers unsuitable for enrollment (e.g., those who anticipate that patients will not be able to adhere to the examination and treatment due to financial and other issues).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Time of umbilical cord blood infusion

    Procedure/Surgery

    Randomization of patients according to the time of umbilical cord blood infusion

Treatment groups

134 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 incidence of grade III to IV aGVHD

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

Time frame
100 days post transplantation

Secondary outcomes

1

The incidence of grade II 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 post transplantation
2

The cumulative incidence of neutrophil engraftment at 42 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
42 days post transplantation
3

The cumulative incidence of platelet engraftment at 60 days after transplantation

Platelet engraftment is defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥ 20 × 10\^9/L.

Time frame
60 days post transplantation
4

The cumulative incidence of transplant-related mortality at 360 days after transplantation

The cumulative incidence of transplant-related mortality at 360 days after transplantation

Time frame
360 days post transplantation

Other outcomes

Sponsors and contacts

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