IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01333605
• Other study ID #: LMTG 11-02
• Status: Recruiting
• Phase: Phase 2
• First received: April 11, 2011
• Last updated: March 2, 2013
• Start date: April 2011
• Est. completion date: June 2014

Study information

• Verified date: March 2013
• Source: Fudan University
• Contact: Ye Guo, MD
• Phone: 86 21 64175590
• Email: pattrick_guo[@]msn.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate		6 weeks	No
Secondary	Overall response rate		6 weeks	No
Secondary	3-year progression-free survival rate		3 years	No
Secondary	3-year overall survival rate		3 years	No