Hodgkin LymphomaPhase 2NCT01333605
IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma
A Phase 2 study testing IGEV in people with Hodgkin Lymphoma, run by Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- IGEV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Liver function: total bilirubin, ALT and AST <1.5×UNL
- Renal function: Cr<1.5×UNL, CCR≧45ml/min
- No contraindication for transplantation
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Ye Guo, MD, 86 21 64175590 ext. 8906, pattrick_guo@msn.com
About this study
Official title: Phase II Study of IGEV Followed by Autologous Stem Cell Transplantation in Patients With Refractory or Relapsed Hodgkin Lymphoma.
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.
Read the 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.
- Conditions
- Hodgkin Lymphoma
- Being tested
- IGEV
- Keywords
- Hodgkin lymphoma, Chemotherapy, IGEV, Autologous stem cell transplantation
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGEVDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: IGEV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Measured: 6 weeks
Secondary outcomes (3)
Overall response rate
Measured: 6 weeks
3-year progression-free survival rate
Measured: 3 years
3-year overall survival rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye Guo, Fudan University
- Investigators
- Ye Guo, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333605
- Sponsor's protocol ID
- LMTG 11-02
- Status last verified
- Mar 2013
- First submitted
- 11 Apr 2011
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of IGEV Followed by Autologous Stem Cell Transplantation in Patients With Refractory or Relapsed Hodgkin Lymphoma.
- ClinicalTrials.gov ID
- NCT01333605
- Acronym / sponsor ID
- LMTG 11-02
- Conditions
- Hodgkin Lymphoma
- Keywords
- Hodgkin lymphoma, Chemotherapy, IGEV, Autologous stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IGEV regimen | Experimental | Drug: IGEVIfosfamide 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGEVIfosfamide 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 regimen |
Primary outcome
Complete response rate
Time frame: 6 weeks
3 secondary outcomes
Overall response rate
Time frame: 6 weeks
3-year progression-free survival rate
Time frame: 3 years
3-year overall survival rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ye Guo, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IGEV in people with Hodgkin Lymphoma, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ye Guo, MD (86 21 64175590 ext. 8906, pattrick_guo@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2013.