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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05335226
Recruitment Status : Recruiting
First Posted : April 19, 2022
Last Update Posted : August 11, 2022
Sponsor:
Information provided by (Responsible Party):
Institute of Hematology & Blood Diseases Hospital

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

Condition or disease Intervention/treatment Phase
Acute Leukemia Procedure: Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation Procedure: haploidentical hematopoietic stem cell transplantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia.
Actual Study Start Date : June 6, 2022
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

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)




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 12 months ]
    Defined as the survival duration starting at the day of transplantation, terminating at the day of death or the end of follow-up

  2. Disease free survival [ Time Frame: 12 months ]
    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


Secondary Outcome Measures :
  1. Cumulative relapse incidence [ Time Frame: 12 months ]
    Defined as the cumulative incidence of relapse after the day of transplantation

  2. Cumulative incidence of engraftment [ Time Frame: 12 months ]
    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

  3. cumulative incidence of acute graft-versus-host disease(GVHD) [ Time Frame: 12 months ]
    Acute graft versus host disease will be diagnosed and graded by modified Glucksberg criteria

  4. cumulative incidence of chronic GVHD at one year [ Time Frame: 12 months ]
    chronic graft versus host disease will be diagnosed and graded by National Institute of Health Consensus (NIH Consensus)

  5. Cumulative Incidence of Infectious Complications [ Time Frame: 12 months ]
    Defined as cumulative incidence of viral, fungal and bacterial infections

  6. Cumulative Incidence of hemorrhagic cystitis [ Time Frame: 12 months ]
    Defined as the cumulative incidence of hemorrhagic cystitis after the day of transplantation

  7. Cumulative Incidence of lymphoproliferative disease [ Time Frame: 12 months ]
    Defined as the cumulative incidence of lymphoproliferative disease after the day of transplantation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05335226


Contacts
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Contact: Aiming Pang +86-13820398091 pangaiming@ihcams.ac.cn

Locations
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China, Tianjin
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences Recruiting
Tianjin, Tianjin, China, 300041
Contact: Erlie Jiang    +86-15122538106    jiangerlie@ihcmas.ac.cn   
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
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Principal Investigator: Erlie Jiang Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT05335226    
Other Study ID Numbers: 20220410
First Posted: April 19, 2022    Key Record Dates
Last Update Posted: August 11, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Hematology & Blood Diseases Hospital:
Acute Leukemia
haplo-hematopoietic stem cell transplantation (haplo-HSCT)
umbilical cord blood stem cell transplantation (UCBT)
Additional relevant MeSH terms:
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Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes