Actively Recruiting

Phase Not Applicable
Age: 10Years - 65Years
All Genders
ID06125483

A Clinical Study of Low-dose Total Body Irradiation and Fludarabine/Busulfan/Melphalan as a Conditioning Regimen for Secondary Umbilical Cord Blood Transplantation in Patients With Hematological Malignancies Who Relapsed After Allo-HSCT

Led by The First Affiliated Hospital of Soochow University · Updated on 2025-04-24

38

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating a new treatment approach for patients with hematological malignancies who have relapsed after allogeneic hematopoietic stem cell transplantation (allo-HSCT). About one-third of these patients experience relapse with HLA loss, which limits the effectiveness of donor lymphocyte infusions. Secondary transplantation using umbilical cord blood transplantation (UCBT) is being studied as it may improve outcomes compared to chemotherapy or other treatments. UCBT offers advantages such as higher engraftment rates and lower risks of rejection and chronic graft-versus-host disease (cGVHD). The study evaluates the safety and feasibility of a specific conditioning regimen for secondary UCBT in this patient group.

CONDITIONS

Brief Title

TBI/Flu/Bu/Mel Combined With Secondary UCBT in Patients With Hematological Malignancies Who Relapsed After Allo-HSCT

Who Can Participate

Age: 10Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of any gender aged between 10 and 65 years (inclusive)
  • Confirmed diagnosis of hematological malignancies such as acute lymphoblastic leukemia or acute/chronic myeloid leukemia after allogeneic hematopoietic stem cell transplantation
  • Planned to receive umbilical cord blood transplantation
  • Adequate cardiac, liver, and kidney function: ALT and AST less than or equal to 3 times upper limit of normal; total bilirubin less than or equal to 3 times upper limit of normal; serum creatinine less than or equal to 2 times upper limit of normal or creatinine clearance at least 40 mL/min; left ventricular ejection fraction above 50%
  • Umbilical cord blood donor with at least 6 out of 10 HLA matches
  • Expected survival of at least 3 months
  • Karnofsky performance score of 60% or higher and ECOG status of 2 or less
  • Fully informed and voluntarily signed consent to participate
Not Eligible

You will not qualify if you...

  • History of serious allergic reactions to study drugs
  • Progressive pulmonary infection confirmed by imaging
  • Cardiovascular events such as hypertension, ventricular arrhythmia requiring treatment, acute coronary syndrome, heart failure, stroke, or other severe heart conditions within the past 6 months
  • Active viral infections including HIV, HBV, HCV, or syphilis
  • Pregnant or breastfeeding patients
  • Currently participating in another clinical study
  • Deemed unsuitable for participation by investigators for other reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Conditioning

Duration - 7 days

Participants receive a conditioning regimen including total body irradiation and chemotherapy drugs to prepare for transplantation.

Daily visits over 7 days for treatments

Umbilical Cord Blood Transplantation

Duration - 1 day

Participants receive a transplant of unrelated umbilical cord blood stem cells matched to their HLA type.

1 transplantation day visit (in-person)

Post-transplant Monitoring

Duration - Up to 1 year following transplantation

Participants are monitored closely for engraftment, graft-versus-host disease, relapse, and other complications.

Multiple visits including assessments at day 28, day 100, and periodic visits up to 1 year

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow university

Suzhou, Jiangsu, China

Actively Recruiting

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Research Team

X

Xiaojin Wu, Prof.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Analysis benefits of a second Allo-HSCT after CAR-T cell therapy in patients with relapsed/refractory B-cell acute lymphoblastic leukemia who relapsed after transplant.

Xing-Yu Cao, Jian-Ping Zhang, Yan-Li Zhao...

https://pubmed.ncbi.nlm.nih.gov/37469510

Proceedings from the National Cancer Institute's Second International Workshop on the Biology, Prevention, and Treatment of Relapse After Hematopoietic Stem Cell Transplantation: part III. Prevention and treatment of relapse after allogeneic transplantation.

Marcos de Lima, David L Porter, Minoo Battiwalla...

https://pubmed.ncbi.nlm.nih.gov/24018392

Mechanisms of Leukemia Immune Evasion and Their Role in Relapse After Haploidentical Hematopoietic Cell Transplantation.

Pier Edoardo Rovatti, Valentina Gambacorta, Francesca Lorentino...

https://pubmed.ncbi.nlm.nih.gov/32158444

Incidence, risk factors and clinical outcome of leukemia relapses with loss of the mismatched HLA after partially incompatible hematopoietic stem cell transplantation.

L Crucitti, R Crocchiolo, C Toffalori...

https://pubmed.ncbi.nlm.nih.gov/25371177

Assessment of Patient-Specific Human Leukocyte Antigen Genomic Loss at Relapse After Antithymocyte Globulin-Based T-Cell-Replete Haploidentical Hematopoietic Stem Cell Transplant.

Hengwei Wu, Jimin Shi, Yi Luo...

https://pubmed.ncbi.nlm.nih.gov/35385089

Outcomes among patients with recurrent high-risk hematologic malignancies after allogeneic hematopoietic cell transplantation.

Marco Mielcarek, Barry E Storer, Mary E D Flowers...

https://pubmed.ncbi.nlm.nih.gov/17889352

Treatment, risk factors, and outcome of adults with relapsed AML after reduced intensity conditioning for allogeneic stem cell transplantation.

Christoph Schmid, Myriam Labopin, Arnon Nagler...

https://pubmed.ncbi.nlm.nih.gov/22167752

Second hematopoietic stem cell transplantation as salvage therapy for relapsed acute myeloid leukemia/myelodysplastic syndromes after a first transplantation.

Yaara Yerushalmi, Noga Shem-Tov, Ivetta Danylesko...

https://pubmed.ncbi.nlm.nih.gov/36475520