Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma

Lymphoplasmacytic Lymphoma Clinical Trial

Official title:

Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma With DNA Vaccines Encoding Antigen-Chemokine Fusion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01209871
• Other study ID #: 2009-0465
• Secondary ID: NCI-2012-01897NC
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 26, 2015
• Est. completion date: February 20, 2026

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: February 20, 2026
• Est. primary completion date: February 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoplasmacytic Lymphoma
• Waldenstrom Macroglobulinemia

Intervention

Biological:
• Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine
Given ID

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	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.	At 12 weeks

External Links

•   MD Anderson Cancer Center