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

2008 WHO Myeloid and Lymphocytic Tumor Diagnostic Criteria

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 2*108/kg for mononuclear cells and/or 2*106/kg for CD34+ cells with once to twice leukapheresis. The final product was kept frozen in liquid nitrogen.Auto-PBSCT

Study Overview

• Status: Completed
• Conditions: Lymphoma
• Intervention / Treatment: Drug: high-dose etoposide

• Study Type: Observational
• Enrollment (Actual): 88

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with refractory/relapsed lymphoma

Description

Inclusion Criteria:

• relapsed/refractory lymphoma ,siut APBSCT

Exclusion Criteria:

• bone marrow without involvement by lymphoma cells

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
death	death	10 years
CR	Complete response	10 years
relapse	relapse	10 years

Collaborators and Investigators

• Sponsor: Yang Jun

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2005
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 22, 2017
• First Submitted That Met QC Criteria: April 22, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: high-dose etoposide,autologous peripheral blood stem cell transplantation
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etoposide
• Other Study ID Numbers: 2015KY143

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No