Non-Hodgkin's LymphomaPhase 2NCT00510471
Personalized Active Immunotherapy (Vaccine Therapy) and Sargramostim Given After Standard of Care Treatment With Rituximab and Chemotherapy for Initial Treatment With Lymphoma
A Phase 2 study testing autologous immunoglobulin idiotype-KLH conjugate vaccine in people with Non-Hodgkin's Lymphoma, run by Genitope Corporation at 9 sites in United States.
Trial summary
The treatment being investigated is a patient- and tumor-specific therapy known as a personalized active immunotherapy. Personalized active immunotherapy is an attempt to use a person's own immune system to combat disease. Sargramostim (a.k.a. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- autologous immunoglobulin idiotype-KLH conjugate vaccine
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- 9 sitesUnited States
- Study dates
- May 2007to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Previously untreated follicular NHL
- Stage III or IV disease requiring treatment
- Able to receive rituximab and chemotherapy (rituximab with cyclophosphamide, vincristine, and prednisone either with or without doxorubicin)
- Able to provide tumor sample adequate for Id-KLH manufacture
- ≥ 18 years of age
- At least one bi-dimensionally measurable lesion ≥ 2 cm by CT scan
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Carolinas Medical Center
Charlotte, North Carolina, 28204
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Indiana University Medical Center
Indianapolis, Indiana, 46202
Keck School of Medicine of University Southern California
Los Angeles, California, 90089
Weill Medical College of Cornell University, NY Presbyterian Hospital
New York, New York, 10021
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73174
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
Providence Portland Cancer Center
Portland, Oregon, 97213
About this study
Official title: A Phase 2 Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered With GM-CSF, in Patients With Follicular Non-Hodgkin's Lymphoma (fNHL) Following Primary Treatment With Rituximab and Chemotherapy (R-Chemo)
The treatment being investigated is a patient- and tumor-specific therapy known as a personalized active immunotherapy. Personalized active immunotherapy is an attempt to use a person's own immune system to combat disease. Sargramostim (a.k.a. GM-CSF) is given together with the personalized active immunotherapy because it may increase the immune system's response and, therefore, aid in the effect of the personalized active immunotherapy.
This approach has previously been studied in patients with follicular Non-Hodgkin's lymphoma and other B-cell malignancies. Encouraging efficacy results and a favorable safety profile have been seen to date in these studies.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- autologous immunoglobulin idiotype-KLH conjugate vaccine
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous immunoglobulin idiotype-KLH conjugate vaccineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Genitope Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510471
- Sponsor's protocol ID
- 2007-12
- Status last verified
- Mar 2008
- First submitted
- 31 Jul 2007
- Last updated
- 18 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered With GM-CSF, in Patients With Follicular Non-Hodgkin's Lymphoma (fNHL) Following Primary Treatment With Rituximab and Chemotherapy (R-Chemo)
- ClinicalTrials.gov ID
- NCT00510471
- Acronym / sponsor ID
- 2007-12
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Genitope CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2007
- First posted
- 2 Aug 2007 (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 treatment being investigated is a patient- and tumor-specific therapy known as a personalized active immunotherapy. Personalized active immunotherapy is an attempt to use a person's own immune system to combat disease. Sargramostim (a.k.a. GM-CSF) is given together with the personalized active immunotherapy because it may increase the immune system's response and, therefore, aid in the effect of the personalized active immunotherapy.
This approach has previously been studied in patients with follicular Non-Hodgkin's lymphoma and other B-cell malignancies. Encouraging efficacy results and a favorable safety profile have been seen to date in these studies.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent
- Previously untreated follicular NHL
- Stage III or IV disease requiring treatment
- Able to receive rituximab and chemotherapy (rituximab with cyclophosphamide, vincristine, and prednisone either with or without doxorubicin)
- Able to provide tumor sample adequate for Id-KLH manufacture
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| autologous immunoglobulin idiotype-KLH conjugate vaccine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2008.
- Click here for more information for untreated patients with follicular Non-Hodgkin's lymphoma who require treatmentLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous immunoglobulin idiotype-KLH conjugate vaccine in people with Non-Hodgkin's Lymphoma, run by Genitope Corporation at 9 sites in United States.
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 7 inclusion and 0 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: stopped early, as of the sponsor's last update on 18 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 18 Mar 2008.