IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of IGEV Followed by Autologous Stem Cell Transplantation in Patients With Refractory or Relapsed Hodgkin Lymphoma.

Conditions
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Hodgkin Lymphoma

Intervention / Treatment
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* Drug: IGEV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IGEV regimen<br>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 | Drug: IGEV<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 6 weeks | 
| 3-year progression-free survival rate |  | 3 years | 
| 3-year overall survival rate |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hodgkin lymphoma, Chemotherapy, IGEV, Autologous stem cell transplantation