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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Hodgkin Lymphoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Ye Guo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

LMTG 11-02

NCT ID:

NCT01333605

Start Date:

April 2011

Completion Date:

June 2014

Related Keywords:

  • Hodgkin Lymphoma
  • Hodgkin lymphoma
  • Chemotherapy
  • IGEV
  • Autologous stem cell transplantation
  • Hodgkin Disease
  • Lymphoma

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