NCT02306837

Brief Summary

To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical trial to test the efficacy and feasibility of consolidation chemotherapy after autologous stem cell transplantation

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
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

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

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

4 years

First QC Date

December 1, 2014

Last Update Submit

September 6, 2016

Conditions

Effects of Chemotherapy

Keywords

lymphoma, consolidation chemotherapy, auto-HSCT

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    2-year

Secondary Outcomes (3)

  • overall survival

    2-year

  • progression

    2-year

  • transplantation-related mortality

    2-year

Study Arms (1)

Consolidation chemo

EXPERIMENTAL

Patients recieved 3 cycles of consolidation chemotherapy post-auto-HSCT: mini-Bu-Cy-E regimen

Drug: Bu-CY-E

Interventions

Bu-CY-EDRUG

mini Bu-Cy-E as consolidation chemotherapy after autologous HSCT

Also known as: mini Bu-Cy-E
Consolidation chemo

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with relapsed or refracotry NHL or HD: PR or SD after first line salvage chemotherapy;
  • ECOG: 0-2
  • Tbil \< 1.5x ULN and AST/ALT \<2.5x ULN
  • With informed consent

You may not qualify if:

  • Life expectancy \< 3 months
  • Women in pregnancy
  • uncontrollable infection disease
  • serum Cr \>400mmol/l
  • uncontroled diabetis and heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, 200025, China

RECRUITING

Shanghai No 10 Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jiong Hu, M.D,

    Rui Jin Hospital, Shanghai Jiaotong Unic\versity School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiong Hu, M.D,

CONTACT

86-21-64370045hujiong@medmail.com.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Blood & Marrow Transplantation Center

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 3, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2018

Study Completion

September 1, 2019

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations

CN(2)