Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma
Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma With DNA Vaccines Encoding Antigen-Chemokine Fusion
NCT01209871CI-TRIAL-00116020completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoplasmacytic Lymphoma | Lymphoplasmacytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine | Biological | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (vaccine therapy)
- description
- Patients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks.
- interventionNames
- Biological: Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- 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
- timeFrame
- 4 weeks
- description
- Toxicity type and severity will be summarized by frequency tables.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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: * 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
References
Publications (1)
- DERIVEDThomas 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. PMID 29439670