NCT01455272

Brief Summary

Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia, particularly for patients with advanced-stage leukemia. However, relapse rate was still very high for advanced-stage leukemia. It was found in our previous study that infusion of granulocyte colony-stimulating factor (G-CSF)-primed peripheral blood progenitor cells (GPBPC) instead of non-primed lymphocytes exhibited a comparative or stronger graft-versus-leukemia (GVL) effect and comparative or less incidence of GVHD, rarely being complicated with pancytopenia. When GPBPC infusion was combined with the use of short-term immunosuppressant for GVHD prophylaxis, the incidence of fatal GVHD complicated with GPBPCI was further reduced. Our primary data showed the GPBPCI combined with the use of short-term immunosuppressant was feasible in patients with advanced leukemia to prevent relapse after HLA-mismatched HSCT. The study hypothesis: Prevention of relapse using granulocyte colony-stimulating factor-primed peripheral blood progenitor cells following hematopoietic stem cell transplantation in patients with advanced-stage acute leukemia can

  • reduce relapse rate
  • improve survival

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable leukemia

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable leukemia

Geographic Reach
1 country

6 active sites

Status
completed

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

July 1, 2009

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

4.7 years

First QC Date

October 12, 2011

Last Update Submit

April 5, 2015

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

  • relapse rate

    one year after HSCT

Secondary Outcomes (1)

  • survival probability

    one year after transplant

Study Arms (1)

high-risk leukemia

EXPERIMENTAL
Procedure: prophylactic GPBPCI

Interventions

prophylactic GPBPCIPROCEDURE

A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic relapse was diagnosed

Also known as: modified DLI
high-risk leukemia

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • high-risk leukemia after HSCT

You may not qualify if:

  • active GVHD
  • early relapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Lanzhou General Hospital of Lanzhou Command

Lanzhou, Gansu, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

The First Affiliated Hospital of Medical School of Zhejiang University

Hangzhou, Zhejiang, China

Location

Peking University People's Hospital，Institute of Hematology

Beijing, 100044, China

Location

Xinqiao Hospital,Third Military Medical University

Chongqing, China

Location

Related Publications (3)

  • Yan CH, Wang Y, Sun YQ, Cheng YF, Mo XD, Wang FR, Chen YH, Zhang YY, Han TT, Chen H, Xu LP, Zhang XH, Liu KY, Huang XJ. Optimized therapeutic strategy for patients with refractory or relapsed acute myeloid leukemia: long-term clinical outcomes and health-related quality of life assessment. Cancer Commun (Lond). 2022 Dec;42(12):1387-1402. doi: 10.1002/cac2.12376. Epub 2022 Oct 23.

    PMID: 36274263DERIVED

  • Zhou YL, Wu LX, Peter Gale R, Wang ZL, Li JL, Jiang H, Jiang Q, Jiang B, Cao SB, Lou F, Sun Y, Wang CC, Liu YR, Wang Y, Chang YJ, Xu LP, Zhang XH, Liu KY, Ruan GR, Huang XJ. Mutation topography and risk stratification for de novo acute myeloid leukaemia with normal cytogenetics and no nucleophosmin 1 (NPM1) mutation or Fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD). Br J Haematol. 2020 Jul;190(2):274-283. doi: 10.1111/bjh.16526. Epub 2020 Feb 26.

    PMID: 32103499DERIVED

  • Yan CH, Liu QF, Wu DP, Zhang X, Xu LP, Zhang XH, Wang Y, Huang H, Bai H, Huang F, Ma X, Huang XJ. Prophylactic Donor Lymphocyte Infusion (DLI) Followed by Minimal Residual Disease and Graft-versus-Host Disease-Guided Multiple DLIs Could Improve Outcomes after Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Refractory/Relapsed Acute Leukemia. Biol Blood Marrow Transplant. 2017 Aug;23(8):1311-1319. doi: 10.1016/j.bbmt.2017.04.028. Epub 2017 May 5.

    PMID: 28483716DERIVED

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • XiaoJun Huang, M.D.

    Peking University People's Hospital，Institute of Hematology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of Peking University People's Hospital，Institute of Hematology

Study Record Dates

First Submitted

October 12, 2011

First Posted

October 19, 2011

Study Start

July 1, 2009

Primary Completion

March 1, 2014

Study Completion

March 1, 2015

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

CN(6)