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Clinical Trials/NCT02306837
NCT02306837UnknownPhase 2

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

Shanghai Jiao Tong University School of Medicine2 sites in 1 country40 target enrollmentStarted: September 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
progression free survival

Study Overview

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

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
16 Years to 60 Years (Child, Adult)
Sex
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

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

Arms & Interventions

Consolidation chemo

Experimental

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

Intervention: Bu-CY-E (Drug)

Outcomes

Primary Outcomes

progression free survival

Time Frame: 2-year

Secondary Outcomes

  • overall survival(2-year)
  • progression(2-year)
  • transplantation-related mortality(2-year)

Investigators

Sponsor
Shanghai Jiao Tong University School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jiong HU

Head, Blood & Marrow Transplantation Center

Shanghai Jiao Tong University School of Medicine

Study Sites (2)

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