IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma

Phase 2

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: IGEV

• Registration Number: NCT01333605
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-11
• Study First Posted: 2011-04-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-02
• Last Update Posted: 2013-03-05
• Primary Completion: 2014-04
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IGEV regimen	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

Primary Outcome Measures

Name	Time	Method
Complete response rate	6 weeks

Secondary Outcome Measures

Name	Time	Method
Overall response rate	6 weeks
3-year progression-free survival rate	3 years
3-year overall survival rate	3 years

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China