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Acute LeukemiaNCT02487069

Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

A study testing HSCT from MSD, HSCT from MUD and HSCT from HRD in people with Acute Leukemia and Chronic Myeloid Leukemia, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
HSCT from MSD, HSCT from MUD and HSCT from HRD
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
876 participants
Where
1 siteChina
Study dates
Jun 2015to 29 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Hematology,Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

Other trials in China

About this study

Official title: Allogeneic Stem Cell Transplantation 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.

Read the detailed description

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.

Being tested
HSCT from MSD, HSCT from MUD, HSCT from HRD, Cyclosporin A, Methotrexate
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSCT from MSDProcedure or surgery

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

  • HSCT from MUDProcedure or surgery

    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 HRDProcedure or surgery

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

  • Cyclosporin ADrug

    Also called CsA

    CsA is used in all the patients for GVHD prophylaxis.

  • MethotrexateDrug

    Also called MTX

    MTX is used in all the patients for GVHD prophylaxis.

  • Antithymocyte globulinDrug

    Also called ATG

    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.

  • Mycophenolate mofetilDrug

    Also called MMF

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

Study groups in NCT02487069
Study groupRoleWhat they receive
MSD groupExperimentalThe patients will received HSCT from MSD.
Receives: Procedure: HSCT from MSD; Drug: Cyclosporin A; Drug: Methotrexate; Drug: Mycophenolate mofetil
MUD groupExperimentalThe patients will received HSCT from MUD.
Receives: Procedure: HSCT from MUD; Drug: Cyclosporin A; Drug: Methotrexate; Drug: Antithymocyte globulin
HRD groupExperimentalThe patients will received HSCT from HRD.
Receives: Procedure: HSCT from HRD; Drug: Cyclosporin A; Drug: Methotrexate; Drug: Antithymocyte globulin; Drug: Mycophenolate mofetil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

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

    Measured: 3 year

Secondary outcomes (5)

  1. Disease-free survival

    Measured: 3 year

  2. Incidence of transplantation-related mortality

    Measured: 3 year

  3. Incidence of graft-versus-host disease

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

    Measured: 3 year

  4. Incidence of infection

    Infection includes bacterial, fungal and viral infections.

    Measured: 3 year

  5. hematopoietic reconstruction

    Hematopoietic reconstruction includes the time of neutrophil and platelet reconstruction.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2015 (estimated)
  2. Study startJun 2015
  3. Primary completion31 Jan 2020
  4. Study completion29 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
876 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02487069
Sponsor's protocol ID
Alternative Donor HSCT-2015
Status last verified
Mar 2019
First submitted
14 Jun 2015
Last updated
5 Mar 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Luo Y, Xiao H, Lai X, Shi J, Tan Y, He J, Xie W, Zheng W, Zhu Y, Ye X, Yu X, Cai Z, Lin M, Huang H. T-cell-replete haploidentical HSCT with low-dose anti-T-lymphocyte globulin compared with matched sibling HSCT and unrelated HSCT. Blood. 2014 Oct 23;124(17):2735-43. doi: 10.1182/blood-2014-04-571570. Epub 2014 Sep 11.

    PubMed 25214441

  • Lu DP, Dong L, Wu T, Huang XJ, Zhang MJ, Han W, Chen H, Liu DH, Gao ZY, Chen YH, Xu LP, Zhang YC, Ren HY, Li D, Liu KY. Conditioning including antithymocyte globulin followed by unmanipulated HLA-mismatched/haploidentical blood and marrow transplantation can achieve comparable outcomes with HLA-identical sibling transplantation. Blood. 2006 Apr 15;107(8):3065-73. doi: 10.1182/blood-2005-05-2146. Epub 2005 Dec 27.

    PubMed 16380454

  • Ling Y, Xuan L, Xu N, Huang F, Fan Z, Guo Z, Xu X, Liu H, Lin R, Yu S, Zhang H, Jin H, Wu M, Liu C, Liang X, Ou R, Zhang Y, Liu X, Qu H, Zhai X, Sun J, Zhao Y, Liu Q. Busulfan Plus Fludarabine Compared With Busulfan Plus Cyclophosphamide for AML Undergoing HLA-Haploidentical Hematopoietic Cell Transplantation: A Multicenter Randomized Phase III Trial. J Clin Oncol. 2023 Oct 10;41(29):4632-4642. doi: 10.1200/JCO.23.00101. Epub 2023 Jun 19.

    PubMed 37335960

Questions about this trial

What is this clinical trial studying?

A study testing HSCT from MSD, HSCT from MUD and HSCT from HRD in people with Acute Leukemia and Chronic Myeloid Leukemia, run by Nanfang Hospital, Southern Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 3 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02487069, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.

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