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

Acute Leukemia Clinical Trial

Official title:

The Efficacy and Safety of Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05335226
• Other study ID #: 20220410
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: August 2022
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Aiming Pang
• Phone: +86-13820398091
• Email: pangaiming[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: March 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Intervention

Procedure:
• Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation
Patients will receive umbilical cord blood allogeneic stem cell transplantation at the same day as the haploidentical stem cell transplantation. (HLA 6-10/10, TNC=1-3×10-7/Kg)
• haploidentical hematopoietic stem cell transplantation
Receive haploidentical hematopoietic stem cell transplantation (HLA 6-10/10)

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Defined as the survival duration starting at the day of transplantation, terminating at the day of death or the end of follow-up	12 months
Primary	Disease free survival	Defined as the time starting at the day of transplantation, terminating at the day when the sign of AL is found or the end of follow-up	12 months
Secondary	Cumulative relapse incidence	Defined as the cumulative incidence of relapse after the day of transplantation	12 months
Secondary	Cumulative incidence of engraftment	Neutrophil recovery was defined as an absolute neutrophil count(ANC) of 0.5×10^9/L or more for three consecutive days , while platelet recovery difined as 20×10^9/L or more for seven consecutive days without transfusion	12 months
Secondary	cumulative incidence of acute graft-versus-host disease(GVHD)	Acute graft versus host disease will be diagnosed and graded by modified Glucksberg criteria	12 months
Secondary	cumulative incidence of chronic GVHD at one year	chronic graft versus host disease will be diagnosed and graded by National Institute of Health Consensus (NIH Consensus)	12 months
Secondary	Cumulative Incidence of Infectious Complications	Defined as cumulative incidence of viral, fungal and bacterial infections	12 months
Secondary	Cumulative Incidence of hemorrhagic cystitis	Defined as the cumulative incidence of hemorrhagic cystitis after the day of transplantation	12 months
Secondary	Cumulative Incidence of lymphoproliferative disease	Defined as the cumulative incidence of lymphoproliferative disease after the day of transplantation	12 months