Loading clinical trials...

Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

NCT01209871•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Detailed Description

PRIMARY OBJECTIVES: 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

February 26, 2015

Primary Completion Date

February 20, 2026

Completion Date

February 20, 2026

Last Updated

November 10, 2025

Enrollment

ACTUAL participants

Conditions

Lymphoplasmacytic Lymphoma

Interventions

Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine

BIOLOGICAL

Laboratory Biomarker Analysis

OTHER

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

NCT04195633

Acute LeukemiaAcute Lymphoblastic Leukemia+17 more

View study

RECRUITINGPHASE1

AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas

NCT06340737

Follicular LymphomaMantle Cell Lymphoma+6 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma

Inclusion Criteria

Exclusion Criteria

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas

64Cu-LLP2A for Imaging Hematologic Malignancies

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T

Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy