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NCT Number: NCT02487069

Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

The purpose of this study is to compare the efficacy of allogeneic hematopoietic stem cell transplantation (allo-HSCT) from matched sibling donor (MSD),matched unrelated donor (MUD) and haploidentical related donors(HRD) in the treatment of hematologic malignancy.

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Key information

Conditions

Acute Leukemia Bone Marrow Diseases Chronic Disease Chronic Myeloid Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myelodysplastic Syndrome Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

About this study

Currently, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative therapy for a majority of malignant hematologic diseases, especially acute leukemia. HSCT from MSD offers the best results for these diseases, but lack of this donor resource has restricted its wide application. HSCT from MUD provides another option, but MUDs still cannot satisfy all patients due to unsuccessful donor searches. Almost all patients have an available related donor with whom they share a single HLA haplotype (ie, haploidentical related donor), and it owns the advantage of immediate availability, especially for those who urgently need transplantation.The results of transplantation from HRD have improved significantly over the past few years. However, the results from such haploidentical transplantation have not formally been compared with those of transplantation in patients contemporaneously using MSDs and MUDs for hematologic malignancy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of primary disease is acute leukemia/MDS/CML
  • Receiving allo-HSCT

Exclusion criteria

  • cardiac dysfunction (particularly congestive heart failure)
  • hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase> 2 times the upper limit of normal)
  • renal dysfunction (creatinine clearance rate < 30 mL/min)
  • Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
  • Patients with any conditions not suitable for the trial (investigators' decision)

Treatment and study plan

HSCT from MSD

Procedure

HSCT from MSD is the first choice for the patients who have HLA-matched sibling donors.

HSCT from MUD

Procedure

HSCT from MUD is the second choice for the patients who don't have HLA-matched sibling donors but have HLA-matched unrelated donors.

HSCT from HRD

Procedure

HSCT from HRD is the choice for the patients who have neither HLA-matched sibling donors nor HLA-matched unrelated donors.

cyclosporin A

Drug

CsA is used in all the patients for GVHD prophylaxis.

Other names: CsA

methotrexate

Drug

MTX is used in all the patients for GVHD prophylaxis.

Other names: MTX

Antithymocyte globulin

Drug

ATG is used in the patients receiving HSCT from MUD and HRD for GVHD prophylaxis.In MUD group,total ATG doses is 7 mg/kg;In HRD group,total ATG doses is 7.5 or 10 mg/kg.

Other names: ATG

Mycophenolate mofetil

Drug

MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.

Other names: MMF

Primary outcomes

  1. Overall Survival

    Time frame: 3 year

    The primary endpoint is overall survival within 3 years after HSCT.

Secondary outcomes

  1. Disease-free survival

    Time frame: 3 year

  2. Incidence of transplantation-related mortality

    Time frame: 3 year

  3. Incidence of graft-versus-host disease

    Time frame: 3 year

    Graft-versus-host disease include acute and chronic Graft-versus-host disease

  4. Incidence of infection

    Time frame: 3 year

    Infection includes bacterial, fungal and viral infections.

  5. hematopoietic reconstruction

    Time frame: 1 year

    Hematopoietic reconstruction includes the time of neutrophil and platelet reconstruction.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • First Affiliated Hospital of Guangxi Medical University
  • Fujian Medical University Union Hospital
  • Guangdong Provincial People's Hospital
  • Guangzhou First People's Hospital
  • Guangzhou General Hospital of Guangzhou Military Command
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Third Affiliated Hospital, Sun Yat-Sen University
  • Tongji Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Xiangya Hospital of Central South University
  • Zhujiang Hospital

Registry information

Official study title

Allogeneic Stem Cell Transplantation With Alternative Donor in Treatment of Hematologic Malignancy

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 1, 2015
Registry last updated
Mar 5, 2020

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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