Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia

Institute of Hematology & Blood Diseases Hospital, China

Status: Enrolling

Conditions: Acute Leukemia

Treatments: Procedure: Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation; Procedure: haploidentical hematopoietic stem cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05335226

20220410

Details and patient eligibility

About

Allogeneic stem cell transplantation (Allo-HSCT) is the effective and even the only treatment option for acute leukemia. The haplo-hematopoietic stem cell transplantation(haplo-HSCT) and "GIAC" protocol have crossed HLA barrier and helped more patients find donors. However, the engraftment failure and incidence of graft-versus-host disease(GVHD) limit the prognosis of patients who receive the haplo-HSCT. It is believed that Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation improved hematopoietic reconstitution and reduced the incidence of GVHD, there is still no consensus about the efficacy and safety of this kind of therapy. This prospective, randomized and controlled study is to investigate the efficacy and safety of Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation

Full description

This prospective, randomized and controlled study is to investigate the efficacy and safety of Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation. Investigators will recruit 116 patients with acute leukemia, with 58 of them entering the haplo-HSCT group and receiving haploidentical hematopoietic stem cell transplantation, while the other 58 entering the combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group and receiving haploidentical and umbilical cord blood allogeneic stem cell transplantation at the same day. Then primary outcomes including overall survival and disease free survival, as well secondary outcomes such as cumulative relapse incidence and cumulative incidence of engraftment will be measured during 12 months after the intervention being finished.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 16-65 years inclusive.
• Diagnosed as acute leukemia, planning to receive haplo-HSCT
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
• Presence of an available haploidentical donor
• Signing written informed consent and agreeing with taking designated umbilical cord blood

Exclusion criteria

• Uncontrolled infections less than 4 weeks prior to enrollment
• Secondary malignancy
• Psychiatric illness that would limit compliance with study requirements
• Impairment of heart, hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
• Allergic to blood products
• Other causes which are not suitable for the trial in investigator's consideration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Haplo-HSCT group

Experimental group

Description:

58 patients will be involved in this group

Treatment:

Procedure: haploidentical hematopoietic stem cell transplantation

Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group

Experimental group

Description:

58 patients will be involved in this group

Treatment:

Procedure: Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation