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

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

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

Study Overview

• Status: Recruiting
• Conditions: Acute Leukemia
• Intervention / Treatment: Procedure: haploidentical hematopoietic stem cell transplantation; Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300041
      • Recruiting
      • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
      • Contact: Erlie Jiang; Phone Number: +86-15122538106; Email: jiangerlie@ihcmas.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Haplo-HSCT group; 58 patients will be involved in this group	Procedure: haploidentical hematopoietic stem cell transplantation; Receive haploidentical hematopoietic stem cell transplantation (HLA 6-10/10)
Experimental: Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group; 58 patients will be involved in this group	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative relapse incidence	Defined as the cumulative incidence of relapse after the day of transplantation	12 months
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
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
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
Cumulative Incidence of Infectious Complications	Defined as cumulative incidence of viral, fungal and bacterial infections	12 months
Cumulative Incidence of hemorrhagic cystitis	Defined as the cumulative incidence of hemorrhagic cystitis after the day of transplantation	12 months
Cumulative Incidence of lymphoproliferative disease	Defined as the cumulative incidence of lymphoproliferative disease after the day of transplantation	12 months

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Acute Leukemia; haplo-hematopoietic stem cell transplantation (haplo-HSCT); umbilical cord blood stem cell transplantation (UCBT)
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Leukemia; Acute Disease
• Other Study ID Numbers: 20220410

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No