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IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma

Primary Purpose

Hodgkin Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

IGEV

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Hodgkin lymphoma, Chemotherapy, IGEV, Autologous stem cell transplantation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IGEV regimen

Arm 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

Outcomes

Primary Outcome Measures

Complete response rate

Secondary Outcome Measures

Overall response rate

3-year progression-free survival rate

3-year overall survival rate

Full Information

NCT ID

NCT01333605

First Posted

April 11, 2011

Last Updated

March 2, 2013

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01333605

Brief Title

IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

April 2011 (undefined)

Primary Completion Date

April 2014 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin Lymphoma

Keywords

Hodgkin lymphoma, Chemotherapy, IGEV, Autologous stem cell transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IGEV regimen

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

IGEV

Intervention Description

Primary Outcome Measure Information:

Title

Complete response rate

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Overall response rate

Time Frame

6 weeks

Title

3-year progression-free survival rate

Time Frame

3 years

Title

3-year overall survival rate

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ye Guo, MD

Phone

86 21 64175590

Ext

8906

pattrick_guo@msn.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ye Guo, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ye Guo, MD

Phone

86 21 64175590

Ext

8906

pattrick_guo@msn.com

12. IPD Sharing Statement

Learn more about this trial

IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma

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