Clinical trial NCT05335226: Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia
Official title: The Efficacy and Safety of Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Leukemia
Keywords: Acute Leukemia
haplo-hematopoietic stem cell transplantation (haplo-HSCT)
umbilical cord blood stem cell transplantation (UCBT)
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 12 months
measure: Disease free survival
timeFrame: 12 months
Secondary outcomes:
measure: Cumulative relapse incidence
timeFrame: 12 months
measure: Cumulative incidence of engraftment
timeFrame: 12 months
measure: cumulative incidence of acute graft-versus-host disease(GVHD)
timeFrame: 12 months
measure: cumulative incidence of chronic GVHD at one year
timeFrame: 12 months
measure: Cumulative Incidence of Infectious Complications
timeFrame: 12 months
measure: Cumulative Incidence of hemorrhagic cystitis
timeFrame: 12 months
measure: Cumulative Incidence of lymphoproliferative disease
timeFrame: 12 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
state: Tianjin
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Erlie Jiang
role: PRINCIPAL_INVESTIGATOR
References: