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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2024-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Umbilical Cord Mesenchymal Stem Cells as First-line Treatment for Patients With Acute Graft Versus Host Disease

NCT05531266

aGVHD

UNKNOWN NA

A Retrospective Study on the Relationship Between Donor Leukocyte Telomere Length and Prognosis of Acute Leukemia Patients Treated With Allogeneic Hematopoietic Stem Cell Transplantation

NCT06076226

Acute Leukemia

RECRUITING

Umbilical Cord Blood Transfusion in Consolidation Therapy of Elderly Patients With Acute Myeloid Leukemia

NCT04687657

Leukemia, Myelomonocytic, Acute

UNKNOWN PHASE1

Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia

NCT04174586

Safety Issues Efficiency

UNKNOWN PHASE1

Outcome of Allogeneic Hematopoietic Stem Cell Transplantation

NCT06702111

Hematopoietic Stem Cell Transplant (HSCT)

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Haplo-HSCT group

58 patients will be involved in this group

Group Type EXPERIMENTAL

haploidentical hematopoietic stem cell transplantation

Intervention Type PROCEDURE

Receive haploidentical hematopoietic stem cell transplantation (HLA 6-10/10)

Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group

58 patients will be involved in this group

Group Type EXPERIMENTAL

Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation

Intervention Type PROCEDURE

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type PROCEDURE

haploidentical hematopoietic stem cell transplantation

Receive haploidentical hematopoietic stem cell transplantation (HLA 6-10/10)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No