IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma

NCT01333605 | Unknown Phase 2

• 1 other identifier: LMTG 11-02
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin Lymphoma

Keywords

Hodgkin lymphoma; Chemotherapy; IGEV; Autologous stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  6 weeks

Secondary Outcomes (3)

• Overall response rate

  6 weeks

• 3-year progression-free survival rate

  3 years

• 3-year overall survival rate

  3 years

Study Arms (1)

IGEV regimen

EXPERIMENTAL

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

Interventions

IGEV DRUG

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.

IGEV regimen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ye Guo, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ye Guo, MD

CONTACT

86 21 64175590; pattrick_guo@msn.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 12, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

CN (1)