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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01333605

Enrollment

Registered

2011-04-12

Start date

2011-04-30

Completion date

2014-06-30

Last updated

2013-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Lymphoma

Keywords

Hodgkin lymphoma, Chemotherapy, IGEV, Autologous stem cell transplantation

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.

Interventions

DRUGIGEV

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Complete response rate	6 weeks

Secondary

Measure	Time frame
Overall response rate	6 weeks
3-year progression-free survival rate	3 years
3-year overall survival rate	3 years

Countries

China

Contacts

Primary ContactYe Guo, MD

pattrick_guo@msn.com86 21 64175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026