Clincosm LogoSign in Get a demo

High-dose Etoposide Could Discriminate Patients With Refractory/Relapsed Lymphoma Benefit From APBSCT

Sponsor
Yang Jun (Other)
Overall Status
Completed
CT.gov ID
NCT03130582
Collaborator
(none)
88
Enrollment
133
Actual Duration (Months)

Study Details

Study Description

Brief Summary

patients with refractory /relapsed lymphoma received high-dose etoposide for hematopoietic stem cell (HSC) mobilization.All patients received high-dose etoposide 20-25 mg/kg/d intravenously for two consecutive days followed by rhG-CSF10ug/kg/day subcutaneously at 48 hours after chemotherapy; rhG-CSF was continued until the end of harvesting for HSCs/HPCs. Peripheral blood counts were performed daily for all patients following the initiating of rhG-CSF. Leukapheresis was performed when peripheral blood white blood count exceeded 4×109/L with blood cell The harvested cells reached at least 2108/kg for mononuclear cells and/or 2106/kg for CD34+ cells with once to twice leukapheresis. The final product was kept frozen in liquid nitrogen.Auto-PBSCT

Condition or Disease Intervention/Treatment Phase
  • Drug: high-dose etoposide

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
88 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
2008 WHO Myeloid and Lymphocytic Tumor Diagnostic Criteria
Actual Study Start Date :
Nov 1, 2005
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Disease status at mobilization PR

Drug: high-dose etoposide
an epipodophyllotoxin, is one of the most common chemotherapy agents for lymphoma without reciprocal resistance with other kinds of agents.
Disease status at mobilization PD

Drug: high-dose etoposide
an epipodophyllotoxin, is one of the most common chemotherapy agents for lymphoma without reciprocal resistance with other kinds of agents.

Outcome Measures

Primary Outcome Measures

  1. death [10 years]

    death

  2. CR [10 years]

    Complete response

  3. relapse [10 years]

    relapse

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • relapsed/refractory lymphoma ,siut APBSCT
Exclusion Criteria:
  • bone marrow without involvement by lymphoma cells

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Yang Jun

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yang Jun, Principal Investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT03130582
Other Study ID Numbers:
  • 2015KY143
First Posted:
Apr 26, 2017
Last Update Posted:
Apr 28, 2017
Last Verified:
Apr 1, 2017
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yang Jun, Principal Investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
high-dose etoposide,autologous peripheral blood stem cell transplantation
Additional relevant MeSH terms:
Lymphoma
Etoposide

Study Results

No Results Posted as of Apr 28, 2017