LymphomaNCT00937183
Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma
A study testing autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine, autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine and autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine in people with Lymphoma and Multiple Myeloma and Plasma Cell Neoplasm, run by Jan Walewski at 1 site in Poland.
Trial summary
RATIONALE: Biological therapies, such as a dendritic cell vaccine made with a patient's cancer cells, may stimulate the immune system in different ways and stop cancer cells from growing. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine, autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine and autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine
- Type of treatment
- Vaccines
- How many people
- 12 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2003to Dec 2017
- Phase
- Interventional
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Mantle cell lymphoma
- Marginal zone lymphoma
- Follicular lymphoma
- Small lymphocytic lymphoma/chronic lymphocytic leukemia
- Multiple myeloma
- Lymphoplasmacytic lymphoma/Waldenström macroglobulinemia
- Diffuse large B-cell lymphoma
- Adequate sample size and lymphoma cell content in the fresh tissue collected
- No bulky or progressive disease
PATIENT CHARACTERISTICS:
- Life expectancy > 3 months
- No evidence of lung, heart, liver, or renal failure or severe neurologic disorder
- No autoimmune disease or atopic allergy
- No HIV positivity
- No other malignancy
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
Poland1 site
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Warsaw, 02-781
About this study
Official title: Vaccination of Lymphoma Patients With Dendritic Cell-lymphoma Cell Hybrids and Dendritic Cells Pulsed With Tumor Lysates
RATIONALE: Biological therapies, such as a dendritic cell vaccine made with a patient's cancer cells, may stimulate the immune system in different ways and stop cancer cells from growing.
PURPOSE: This phase I/II trial is studying the side effects of dendritic cell vaccine and to see how well it works in treating patients with indolent B-cell lymphoma or multiple myeloma.
Read the detailed description
OBJECTIVES:
- Evaluation of feasibility of dendritic cell (DC)-based vaccination program using autologous tumor cells and/or lysates in patients with indolent B cell lymphomas or multiple myeloma as an adjuvant therapy to induce immune response in remission after cytoreductive treatment.
- Evaluation of the immune response of patients treated with this regimen.
- Evaluation the progression-free survival of patients treated this regimen.
- Evaluate the adverse events of this regimen in these patients.
OUTLINE: Patients receive intranodal (under ultrasound guidance) or subcutaneous vaccinations of adjuvant electrofusion hybrids of autologous dendritic cells (DC) with autologous lymphoma cells, electrofusion hybrids of allogeneic DC with autologous lymphoma cells, and/or autologous DC pulsed with autologous tumor lysate cells in weeks 0, 2, 4, 8, 12, 18, 26, and 50.
- Being tested
- autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine, autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine, autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine
- Keywords
- dendritic cell vaccine, tumor cell lysate, lymphoma
- Medical subject headings
- Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccineBiological
autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccineBiological
autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response
Progression-free survival
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startSep 2003
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Walewski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jan Walewski, Maria Sklodowska-Curie National Research Institute of Oncology
- Investigators
- Jan Walewski, MD, Study chair, Maria Sklodowska-Curie National Research Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937183
- Sponsor's protocol ID
- MSCMI-40-2003
- Other IDs
- CDR0000636859, EU-20913
- Status last verified
- Aug 2019
- First submitted
- 8 Jul 2009
- Last updated
- 19 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination of Lymphoma Patients With Dendritic Cell-lymphoma Cell Hybrids and Dendritic Cells Pulsed With Tumor Lysates
- ClinicalTrials.gov ID
- NCT00937183
- Acronym / sponsor ID
- MSCMI-40-2003
- Keywords
- dendritic cell vaccine, tumor cell lysate, lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jan WalewskiUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Jul 2009 (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.
RATIONALE: Biological therapies, such as a dendritic cell vaccine made with a patient's cancer cells, may stimulate the immune system in different ways and stop cancer cells from growing.
PURPOSE: This phase I/II trial is studying the side effects of dendritic cell vaccine and to see how well it works in treating patients with indolent B-cell lymphoma or multiple myeloma.
Detailed description
OBJECTIVES:
- Evaluation of feasibility of dendritic cell (DC)-based vaccination program using autologous tumor cells and/or lysates in patients with indolent B cell lymphomas or multiple myeloma as an adjuvant therapy to induce immune response in remission after cytoreductive treatment.
- Evaluation of the immune response of patients treated with this regimen.
- Evaluation the progression-free survival of patients treated this regimen.
- Evaluate the adverse events of this regimen in these patients.
OUTLINE: Patients receive intranodal (under ultrasound guidance) or subcutaneous vaccinations of adjuvant electrofusion hybrids of autologous dendritic cells (DC) with autologous lymphoma cells, electrofusion hybrids of allogeneic DC with autologous lymphoma cells, and/or autologous DC pulsed with autologous tumor lysate cells in weeks 0, 2, 4, 8, 12, 18, 26, and 50.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 lymphoma cell lysate-pulsed autologous dendritic cell vaccine | Biological | – |
| autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine | Biological | – |
| autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine | Biological | – |
Primary outcome
Immune response
Progression-free survival
Adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
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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.
Jan Walewski, MD study chair
Maria Sklodowska-Curie National Research Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine, autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine and autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine in people with Lymphoma and Multiple Myeloma and Plasma Cell Neoplasm, run by Jan Walewski at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 19 Aug 2019. 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 Poland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Immune response. The study lists 3 primary outcomes in all. 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 19 Aug 2019.