CClinicalTrials.gg
Status unknownNCT02306837Updated Sep 8, 2016

Consolidation Chemotherapy After Autologous Stem Cell Transplantation for Lymphoid Malignancies

A Phase 2 interventional study of Bu-CY-E in Effects of Chemotherapy, sponsored by Shanghai Jiao Tong University School of Medicine. Status unknown at 2 sites in China. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-09-08.

Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
16 Years to 60 Years
Sex
All
01

Study 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

Read the detailed description

Patients with relapsed or refractory lymphoma will be included. All patients will undergo PBSC mobilization with CTX and G-CSF. After sucessful collection of CD34+ over 1x109/L, autologous stem cel ltransplantation with Bu-Cy-E conditioning will be given. Two months after auto-HSCT, a PET-CT will be performed and all patients with CR, CRu and PR will recieved 3 cycles of mini-Bu-Cy-E as consolidation 3, 6 and 9 months after auto-HSCT. For patients with SD or PD after auto-HSCT will refered to the allogeneic transplantatio program and take off the study.

02

Conditions studied

  • Effects of Chemotherapy

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Keywords

  • lymphoma, consolidation chemotherapy, auto-HSCT
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 40 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Life expectancy \< 3 months
  • Women in pregnancy
  • uncontrollable infection disease
  • serum Cr >400mmol/l
  • uncontroled diabetis and heart disease
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Consolidation chemo

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

    Drug: Bu-CY-E

Interventions

  • DrugBu-CY-E

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

    Also known as: mini Bu-Cy-E

06

What researchers measure

Primary outcomes

  1. progression free survival

    Time frame: 2-year

Secondary outcomes

  1. overall survival

    Time frame: 2-year

  2. progression

    PET-CT measurement

    Time frame: 2-year

  3. transplantation-related mortality

    Time frame: 2-year

07

Study locations

2 of 2 sites recruiting
  • Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
    Shanghai, 200025, China
    Recruiting
  • Shanghai No 10 Hospital
    Shanghai, China
    • JunMei Shi, M.D, Ph.D, · Contact
    • JunMei Shi, M.D, Ph.D, · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02306837
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Jiong HU (Head, Blood & Marrow Transplantation Center, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Dec 3, 2014
Start date
Sep 2014
Primary completion
Sep 2018 (estimated)
Completion
Sep 2019 (estimated)
Last update
Sep 8, 2016

Study contacts

Jiong Hu, M.D,
Contact
hujiong@medmail.com.cn
86-21-64370045 ext. 601878
Jiong Hu, M.D,
principal investigator · Rui Jin Hospital, Shanghai Jiaotong Unic\versity School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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