IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Hodgkin Lymphoma

Treatments: Drug: IGEV

Study type: Interventional

Funder types: Other

Identifiers

NCT01333605

LMTG 11-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

IGEV regimen

Experimental group

Description:

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

Treatment:

Drug: IGEV