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NCT Number: NCT05290545

Haplo-PBSC+Cord vs Haplo-PBSC+BM for Hematological Malignancies Undergoing Allo-HSCT

The objective of this study was to explore whether the combination with umbilical cord blood (UCB) is associated with superior disease-free survival (DFS) in the setting of haploidentical donors (HID) transplantation.

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Key information

Conditions

Hematological Malignancies Hematologic Diseases Hematologic Neoplasms Hematopoietic Stem Cell Transplantation Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

About this study

The main causes of allogeneic hematopoietic stem cell transplantation (allo-HSCT) failure are primary disease relapse and transplant-related complications, especially relapse. In recent years, with the development of transplantation technology, alternative donors such as HID and UCB have been widely used. But, these alternative donors are associated with high incidences of transplant-related complications and mortalities when compared with human leukocyte antigen (HLA)-matched donors. Some studies suggeted that mixed grafts might overcome the disadvantages of a single alternative graft. UCB transplant (UCBT) supported by third-party HID or HID transplants supported by third-party UCB has been reported to have rapid engraftment and low incidences of graft-versus-host-disease (GVHD), making survival improvement. However, most of these results came from single-arm studies. The comparative studies between haplo-PBSC+Cord and haplo-PBSC+BM are scarce in the setting of HID transplantation. In a retrospective study, the investigators found haplo-PBSC+Cord transplantation has superior DFS than haplo-PBSC+BM in hematological malignancies. To further confirmed this conclusion, the investigators plan to conduct a prospective, multicenter, phase 3 randomized controlled trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with hematologic malignancies undergoing first HID allo-HSCT
  • Age 18 to 65 years old with ECOG performance status 0-2
  • Received myeloablative conditioning regimens
  • Sign informed consent form, have the ability to comply with study and follow-up procedures

Exclusion criteria

  • Received PBSCs as only grafts
  • Acute leukemia transformed from a myeloproliferative tumor
  • Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
  • Respiratory failure ( PaO2 ≤60mmHg)
  • Hepatic abnormalities (total bilirubin ≥3 mg/dL, aminotransferase >2 times the upper limit of normal)
  • Renal dysfunction (creatinine clearance rate < 30 mL/min)
  • ECOG performance status 3, 4 or 5
  • With any conditions not suitable for the trial (investigators' decision)

Treatment and study plan

PBSCs

Other

PBSCs harvest is performed from day 5 of G-CSF to obtain at least 7.0×10^8 total nucleated cells/kg recipient ideal body weight.

Cord

Other

The criteria for cord selection included the following: (1) ≥3 of 6 HLA loci , (2) blood type matches, (3) contained a minimum cell count of 0.3×10^8 nucleated cells/kg and 0.15×10^6 CD34-positive cells/kg before freezing. The third party UCB will be infused the day after infusion of PBSCs.

BMSCs

Other

BMSCs of donor will be collected and infused at least 0.5×10^8 total nucleated cells/kg recipient ideal body weight the day after PBSCs infusion.

Primary outcomes

  1. Disease-free survival (DFS)

    Time frame: 1 year

Secondary outcomes

  1. Relapse rate

    Time frame: 1 year

  2. Overall survival (OS)

    Time frame: 1 year

  3. The cumulative incidence of hematopoietic engraftment.

    Time frame: 30 days post-transplantation

    Hematopoietic engraftment includes the time of neutrophil and platelet engraftment. Neutrophil engraftment was defined as the first of two consecutive days with an absolute neutrophil count in the peripheral blood exceeding 0.5 × 10^9/L and the platelet engraftment was defined as the first of 3 days with an absolute platelet count exceeding 20 × 10^9 /L without transfusion support.

  4. The cumulative incidence of acute graft-versus-host-disease (GVHD)

    Time frame: 100 days post-transplantation

    Acutue GVHD was defined according to the 1994 consensus conference on acute GVHD grading and graded from I to IV.

  5. The cumulative incidence of chronic GVHD

    Time frame: 1 year

    Chronic GVHD was graded as mild, moderate and severe according to the national institutes of health consensus development project on criteria for clinical trials in chronic GVHD: the 2014 diagnosis and staging working group report.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Dongguan People's Hospital
  • First Affiliated Hospital of Guangxi Medical University
  • First People's Hospital of Chenzhou
  • Hunan Provincial People's Hospital
  • The First People's Hospital of Guangzhou
  • The Seventh Affiliated Hospital of Sun Yat-sen University

Registry information

Official study title

A Comparative Study of Haploidentical Transplantation Supported by Third-party Cord Blood and Haploidentical Transplantation in Hematological Malignancies

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 22, 2022
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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