IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma

Sponsor

Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01333605

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma	Drug: IGEV	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

43 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2011

Anticipated Primary Completion Date :

Apr 1, 2014

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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	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.

Arm

Intervention/Treatment

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

Drug: IGEV

Outcome Measures

Primary Outcome Measures

Complete response rate [6 weeks]

Secondary Outcome Measures

Overall response rate [6 weeks]
3-year progression-free survival rate [3 years]
3-year overall survival rate [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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