IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT01333605
First received: April 11, 2011
Last updated: March 2, 2013
Last verified: March 2013

April 11, 2011
March 2, 2013
April 2011
April 2014   (final data collection date for primary outcome measure)
Complete response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01333605 on ClinicalTrials.gov Archive Site
  • Overall response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 3-year progression-free survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 3-year overall survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma
Phase II Study of IGEV Followed by Autologous Stem Cell Transplantation in Patients With Refractory or Relapsed Hodgkin Lymphoma.

The aim of study is to prove IGEV regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed Hodgkin lymphoma is effective.

The standard treatment in patients with refractory or relapsed Hodgkin lymphoma is salvage chemotherapy followed by autologous transplantation for responsive patients. However, the standard of salvage chemotherapy remains uncertain. This study is to evaluate the efficacy and safety of IGEV regimen in a single-center basis.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hodgkin Lymphoma
Drug: IGEV
Ifosfamide 1200 mg/m2 at days 1-4, Mesna 400 mg 0,4,8h at days 1-4, Gemcitabine 800 mg/m2 at day 1 and day 4, Vinorelbine 20 mg/m2 at day 1, Prednisone 100 mg at days 1-4. Frequency of cycles: every 3 weeks. Numbers of cycles: 4 cycles.
Other Name: IGEV
Experimental: IGEV regimen
Ifosfamide 1200 mg/m2 at days 1-4, Mesna 400 mg 0,4,8h at days 1-4, Gemcitabine 800 mg/m2 at day 1 and day 4, Vinorelbine 20 mg/m2 at day 1, Prednisone 100 mg at days 1-4. Frequency of cycles: every 3 weeks. Numbers of cycles: 4 cycles
Intervention: Drug: IGEV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
43
June 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age range: 18-65 years old
  • Histological confirmed refractory or relapsed Hodgkin lymphoma
  • With at least one site of measurable disease according to IWC criteria
  • ECOG performance status 0-1
  • Life expectancy of more than 3 months
  • Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
  • Liver function: total bilirubin, ALT and AST <1.5×UNL
  • Renal function: Cr<1.5×UNL, CCR≧45ml/min
  • No contraindication for transplantation

Exclusion Criteria:

  • No prior chemotherapy
  • With more than 2 lines of prior chemotherapy exposure
  • Evidence of CNS and bone marrow involvement
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Pregnant or lactating women
  • Significant active infection
Both
18 Years to 65 Years
No
Contact: Ye Guo, MD 86 21 64175590 ext 8906 pattrick_guo@msn.com
China
 
NCT01333605
LMTG 11-02
No
Ye Guo, Fudan University
Fudan University
Not Provided
Principal Investigator: Ye Guo, MD Fudan University
Fudan University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP