NCT03654703

Brief Summary

No more datas about post-transplant cyclophosphamide (PT/Cy) used in pediatric refractory acute myeloid leukemia (R-AML）patients. Investigators reasoned that this group of patients if they have been treated with ablative conditioning regimens for HSCT combined with PT/Cy, under the rapid of immune reconstitution will have better outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

3.3 years

First QC Date

August 28, 2018

Last Update Submit

August 30, 2018

Conditions

Hematopoietic System--Cancer

Keywords

HSCT, AML， R-AML

Outcome Measures

Primary Outcomes (1)

  • Disease status

    Disease status can be measured by test the of (minimal residual disease) MRD via flow cytometry one time each month until one year after HSCT. MRD\<0.0001 （complete remission), if not, relapse.

    1 year

Study Arms (2)

Cyclophophamide

EXPERIMENTAL

Cyclophosphamide 50mg/kg/day on day+3，+4 after HSCT. Intervention: drugs:Cyclophosphamide.

Drug: Cyclophosphamide

Placebo

EXPERIMENTAL

5% GLS（Placebo) 50ml/day on day+3，+4 after HSCT. Intervention: drugs: Placebo other name: placebo (for Cyclophosphamide) 5%Glugose in water 50ml or normal saline

Drug: Cyclophosphamide

Interventions

CyclophosphamideDRUG

cyclophophamide

Also known as: Cy
CyclophophamidePlacebo

Eligibility Criteria

Age3 Years - 18 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • refractory AML

You may not qualify if:

  • \- complete remission AML

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yan Yue

Beijing, Chaoyang District, 100020, China

Location

Related Publications (3)

  • Sugita J, Kagaya Y, Miyamoto T, Shibasaki Y, Nagafuji K, Ota S, Furukawa T, Nara M, Akashi K, Taniguchi S, Harada M, Matsuo K, Teshima T; Japan Study Group for Cell Therapy and Transplantation (JSCT). Myeloablative and reduced-intensity conditioning in HLA-haploidentical peripheral blood stem cell transplantation using post-transplant cyclophosphamide. Bone Marrow Transplant. 2019 Mar;54(3):432-441. doi: 10.1038/s41409-018-0279-1. Epub 2018 Aug 7.

    PMID: 30087460RESULT

  • Marani C, Raiola AM, Morbelli S, Dominietto A, Ferrarazzo G, Avenoso D, Giannoni L, Varaldo R, Gualandi F, Grazia D, Lamparelli T, Bregante S, Van Lint MT, Ibatici A, Bovis F, Lemoli RM, Gobbi M, Bacigalupo A, Angelucci E. Haploidentical Transplants with Post-Transplant Cyclophosphamide for Relapsed or Refractory Hodgkin Lymphoma: The Role of Comorbidity Index and Pretransplant Positron Emission Tomography. Biol Blood Marrow Transplant. 2018 Dec;24(12):2501-2508. doi: 10.1016/j.bbmt.2018.07.025. Epub 2018 Jul 21.

    PMID: 30041010RESULT

  • Law AD, Salas MQ, Lam W, Michelis FV, Thyagu S, Kim DDH, Lipton JH, Kumar R, Messner H, Viswabandya A. Reduced-Intensity Conditioning and Dual T Lymphocyte Suppression with Antithymocyte Globulin and Post-Transplant Cyclophosphamide as Graft-versus-Host Disease Prophylaxis in Haploidentical Hematopoietic Stem Cell Transplants for Hematological Malignancies. Biol Blood Marrow Transplant. 2018 Nov;24(11):2259-2264. doi: 10.1016/j.bbmt.2018.07.008. Epub 2018 Aug 7.

    PMID: 30009980RESULT

MeSH Terms

Interventions

Cyclophosphamide

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Jia Y Qin, MD

    Hematology and oncology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

August 28, 2018

First Posted

August 31, 2018

Study Start

March 1, 2015

Primary Completion

July 1, 2018

Study Completion

March 1, 2020

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)