Know Cancer

or
forgot password

Clinical Study of Granulocyte Colony-stimulating Factor (G-CSF)-Primed, Peripheral-blood Progenitor Cells for the Prevention of Relapse Advanced Stage Leukemia


N/A
N/A
60 Years
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

Clinical Study of Granulocyte Colony-stimulating Factor (G-CSF)-Primed, Peripheral-blood Progenitor Cells for the Prevention of Relapse Advanced Stage Leukemia


A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic
relapse was diagnosed in patients for which no GVHD occurred or free of GVHD after 2 weeks
off immunosuppression for patients receiving GPBPCI after day 90 post HSCT. Before
administration of GPBPCI, serious infection had to be cleared and no serious organ failure
could be present. The GPBPCI regimen was comprised of G-CSF-primed PBSCs instead of
harvested non-primed donor lymphocytes and short-term immunosuppressive agents for
prevention of GVHD after GPBPCI. Chimerism status was examined before and after prophylactic
treatment with GPBPCI.


Inclusion Criteria:



- high-risk leukemia after HSCT

Exclusion Criteria:

- active GVHD

- early relapse

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

relapse rate

Outcome Time Frame:

two years after HSCT

Safety Issue:

Yes

Principal Investigator

XiaoJun Huang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University People's Hospital´╝îInstitute of Hematology

Authority:

China: Ministry of Health

Study ID:

PUPH IRB [2010] (78)

NCT ID:

NCT01455272

Start Date:

July 2009

Completion Date:

December 2015

Related Keywords:

  • Leukemia
  • Leukemia

Name

Location