Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma
NCT ID: NCT01209871
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
9 participants
INTERVENTIONAL
2015-02-26
2026-02-20
Brief Summary
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Detailed Description
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I. 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:
I. 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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (vaccine therapy)
Patients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks.
Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine
Given ID
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine
Given ID
Laboratory Biomarker Analysis
Correlative studies
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sheeba Thomas
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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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.
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2012-01897
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2010-02091
Identifier Type: OTHER
Identifier Source: secondary_id
2009-0465
Identifier Type: OTHER
Identifier Source: secondary_id
2009-0465
Identifier Type: -
Identifier Source: org_study_id