Consolidation Chemotherapy After Autologous Stem Cell Transplantation for Lymphoid Malignancies

September 6, 2016 updated by: Jiong HU, Shanghai Jiao Tong University School of Medicine

A Phase II Trial of Consolidation Chemothetapy for Patients With Relapse or Refractory Lymphoid Malignancies After Autologous Stem Cell Transplantation

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200025
        • Recruiting
        • Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Jiong HU, M.D.
      • Shanghai, China
        • Recruiting
        • Shanghai No 10 Hospital
        • Contact:
          • JunMei Shi, M.D, Ph.D,
        • Principal Investigator:
          • JunMei Shi, M.D, Ph.D,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Consolidation chemo
Patients recieved 3 cycles of consolidation chemotherapy post-auto-HSCT: mini-Bu-Cy-E regimen
Drug: Bu-CY-E
mini Bu-Cy-E as consolidation chemotherapy after autologous HSCT
Other Names:
  • mini Bu-Cy-E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: 2-year
2-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 2-year
2-year
progression
Time Frame: 2-year
PET-CT measurement
2-year
transplantation-related mortality
Time Frame: 2-year
2-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Jiong Hu, M.D,, Rui Jin Hospital, Shanghai Jiaotong Unic\versity School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lym-Auto-RJH-2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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