Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma

NCT01209871 | Active Not Recruiting Phase 1 FDA Drug

• 3 other identifiers: 2009-0465NCI-2012-01897NCI-2010-02091
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoplasmacytic Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immune response defined as at least a three-fold rise in the precursor frequency of tumor-reactive T cells

  At 12 weeks

Study Arms (1)

Treatment (vaccine therapy)

EXPERIMENTAL

Patients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks.

Biological: Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine; Other: Laboratory Biomarker Analysis

Interventions

Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine BIOLOGICAL

Given ID

Treatment (vaccine therapy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (vaccine therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 29439670 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sheeba Thomas

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: September 27, 2010
• Study Start: February 26, 2015
• Primary Completion: February 20, 2026
• Study Completion: February 20, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)