Lymphoplasmacytic LymphomaPhase 1NCT01209871
Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma
A Phase 1 study testing Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine and Laboratory Biomarker Analysis in people with Lymphoplasmacytic Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with lymphoplasmacytic lymphoma. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoplasmacytic Lymphoma
- What is being tested?
- Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine and Laboratory Biomarker Analysis
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2015to 22 Apr 2025
- Phase
- Phase 1
- 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
- Tissue diagnosis of lymphoplasmacytic lymphoma with surface immunoglobulin G (IgG), immunoglobulin A (IgA) or immunoglobulin M (IgM) phenotype with a monoclonal heavy and light chain as determined by flow cytometry; all primary diagnostic lymph node and/or bone marrow biopsies will be reviewed at the University of Texas M.D. Anderson Cancer Center (UTMDACC)
- Previously untreated patients with lymphoplasmacytic lymphoma (of any subtype: IgG, IgA, IgM) in the asymptomatic phase
- Patients must provide a lymph node sample of at least 1.5 cm in the long axis, or a bone marrow aspiration sample providing at least 5 million cluster of differentiation (CD)20 and/or CD38+ (approximately 10 ml)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Serum creatinine =< 1.5 mg/dl and a creatinine clearance >= 30 ml/min
- Total bilirubin =< 1.5 mg/dl unless felt secondary to Gilbert's disease
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- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2 x upper limit of normal
- Ability to provide informed consent, and to return to clinic for adequate follow-up for the period that the protocol requires
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 30 days after the last vaccination has been administered
- Male subject agrees to use an acceptable method for contraception for the duration of the study
Who cannot join
- Human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C infection
- Pregnancy or lactating females
- Patients with previous history of malignancy within the last 5 years except curatively treated squamous or basal cell carcinoma of the skin or curatively treated carcinoma in-situ of other organs
- Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment
- Patients with New York Heart Association class 3 or 4 disease
- Patients with a history of autoimmune diseases except for Hashimoto's thyroiditis
- Patients with positive antinuclear antibody (ANA) and/or anti-double strand (ds) DNA antibodies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma With DNA Vaccines Encoding Antigen-Chemokine Fusion
This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with lymphoplasmacytic lymphoma. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and feasibility of using a novel lymphoma deoxyribonucleic acid (DNA) vaccine encoding macrophage inflammatory protein 3 alpha (MIP3a)-fused lymphoma idiotype in single chain format.
II. To determine the maximum tolerated dose (MTD) of the vaccine.
SECONDARY OBJECTIVES:
- To assess the immunogenicity of the vaccine to generate tumor-specific cellular and humoral immune responses.
OUTLINE: This is a dose-escalation study.
Patients receive autologous lymphoma immunoglobulin-derived single-chain variable fragment (scFV)-chemokine DNA vaccine intradermally (ID) at 0, 4, and 8 weeks.
After completion of study treatment, patients are followed up at 4 weeks, and then every 6 months for 1 year.
- Conditions
- Lymphoplasmacytic Lymphoma
- Being tested
- Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine, Laboratory Biomarker Analysis
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA VaccineBiological
Given ID
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (vaccine therapy) | Experimental | Patients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks. Receives: Biological: Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity according to the National Cancer Institute Common Toxicity Criteria version 4.0
Toxicity type and severity will be summarized by frequency tables.
Measured: 4 weeks
Secondary outcomes (1)
Immune response defined as at least a three-fold rise in the precursor frequency of tumor-reactive T cells
The rate of immune response will be estimated.
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study start26 Feb 2015
- Primary completion22 Apr 2025
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoplasmacytic LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sheeba Thomas, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209871
- Sponsor's protocol ID
- 2009-0465
- Other IDs
- NCI-2012-01897, NCI-2010-02091, 2009-0465
- Status last verified
- Jun 2026
- First submitted
- 24 Sep 2010
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Thomas SK, Cha SC, Smith DL, Kim KH, Parshottam SR, Rao S, Popescu M, Lee VY, Neelapu SS, Kwak LW. Phase I study of an active immunotherapy for asymptomatic phase Lymphoplasmacytic lymphoma with DNA vaccines encoding antigen-chemokine fusion: study protocol. BMC Cancer. 2018 Feb 13;18(1):187. doi: 10.1186/s12885-018-4094-2.
PubMed 29439670
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma With DNA Vaccines Encoding Antigen-Chemokine Fusion
- ClinicalTrials.gov ID
- NCT01209871
- Acronym / sponsor ID
- 2009-0465
- Conditions
- Lymphoplasmacytic Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Feb 2015 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 27 Sep 2010 (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.
This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with lymphoplasmacytic lymphoma. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and feasibility of using a novel lymphoma deoxyribonucleic acid (DNA) vaccine encoding macrophage inflammatory protein 3 alpha (MIP3a)-fused lymphoma idiotype in single chain format.
II. To determine the maximum tolerated dose (MTD) of the vaccine.
SECONDARY OBJECTIVES:
- To assess the immunogenicity of the vaccine to generate tumor-specific cellular and humoral immune responses.
OUTLINE: This is a dose-escalation study.
Patients receive autologous lymphoma immunoglobulin-derived single-chain variable fragment (scFV)-chemokine DNA vaccine intradermally (ID) at 0, 4, and 8 weeks.
After completion of study treatment, patients are followed up at 4 weeks, and then every 6 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (vaccine therapy) | Experimental | Biological: Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine, Other: Laboratory Biomarker AnalysisPatients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Tissue diagnosis of lymphoplasmacytic lymphoma with surface immunoglobulin G (IgG), immunoglobulin A (IgA) or immunoglobulin M (IgM) phenotype with a monoclonal heavy and light chain as determined by flow cytometry; all primary diagnostic lymph node and/or bone marrow biopsies will be reviewed at the University of Texas M.D. Anderson Cancer Center (UTMDACC)
- Previously untreated patients with lymphoplasmacytic lymphoma (of any subtype: IgG, IgA, IgM) in the asymptomatic phase
- Patients must provide a lymph node sample of at least 1.5 cm in the long axis, or a bone marrow aspiration sample providing at least 5 million cluster of differentiation (CD)20 and/or CD38+ (approximately 10 ml)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Serum creatinine =< 1.5 mg/dl and a creatinine clearance >= 30 ml/min
Key exclusion criteria (7 listed)
- Human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C infection
- Pregnancy or lactating females
- Patients with previous history of malignancy within the last 5 years except curatively treated squamous or basal cell carcinoma of the skin or curatively treated carcinoma in-situ of other organs
- Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment
- Patients with New York Heart Association class 3 or 4 disease
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 Immunoglobulin-derived scFv-chemokine DNA VaccineGiven ID | Biological | Treatment (vaccine therapy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (vaccine therapy) |
Primary outcome
Maximum tolerated dose defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity according to the National Cancer Institute Common Toxicity Criteria version 4.0
Time frame: 4 weeks
Toxicity type and severity will be summarized by frequency tables.
1 secondary outcome
Immune response defined as at least a three-fold rise in the precursor frequency of tumor-reactive T cells
Time frame: At 12 weeks
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 26 Jun 2026.
- Derived from this study: PubMed 29439670Thomas SK, Cha SC, Smith DL, Kim KH, Parshottam SR, Rao S, Popescu M, Lee VY, Neelapu SS, Kwak LW. Phase I study of an active immunotherapy for asymptomatic phase Lymphoplasmacytic lymphoma with DNA vaccines encoding antigen-chemokine fusion: study protocol. BMC Cancer. 2018 Feb 13;18(1):187. doi: 10.1186/s12885-018-4094-2.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
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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.
Sheeba Thomas principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine and Laboratory Biomarker Analysis in people with Lymphoplasmacytic Lymphoma, run by M.D. Anderson Cancer Center at 1 site 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 10 inclusion and 7 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: finished, as of the sponsor's last update on 26 Jun 2026. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Maximum tolerated dose defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity according to the National Cancer Institute Common Toxicity Criteria version 4.0 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01209871, which also lists 1 linked publication.
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 26 Jun 2026.