Combination Veltuzumab and Fractionated 90Y- Epratuzumab Radioimmunotherapy in Follicular Lymphoma

• Status: Terminated
• Trial end date: 2015-07-31
• Target enrollment: 0
• Participant gender: All

Summary

A Phase I/II clinical trial using a fractionated dosing regimen of 90Y-epratuzumab (anti-CD22) has showed encouraging responses in follicular and aggressive NHL with an ability to administer safely 2 injections of 20 mCi/m2 spaced 1 week apart. The investigators propose to combine this active 90Y-epratuzumab treatment with a regimen of veltuzumab that was also found active in Phase I/II trials.

The goal of this study is to determine the safety and efficacy of 90Y-epratuzumab when used in combination with veltuzumab. The primary objective is to determine the response rate of this combination treatment. Secondary objectives are to assess safety, pharmacokinetics and targeting of 90Y-epratuzumab . Veltuzumab blood levels and anti-antibody responses will also be monitored at various times.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborators: Gilead Sciences; Immunomedics, Inc.
• Treatments: 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid; Epratuzumab; Veltuzumab

Criteria

Inclusion Criteria:

• Male or female, >18 years old

• Histological diagnosis of CD20+ Follicular lymphoma by WHO lymphoma criteria.

• FLIPI intermediate or high risk (2-5 risk factors)

• No prior systemic treatment for NHL

• Measurable disease by CT, with at least one lesion >1.5 cm in one dimension

• Life expectancy of at least 6 months

• ECOG performance status > = 2

• Patients must have normal organ and marrow function as defined below:

• ANC > = 1,500/uL

• platelets > = 100,000/uL

• total bilirubin < = 1.5 x upper limit of normal

• AST(SGOT)/ALT(SGPT) < = 2.5 X upper limit of normal

• creatinine < = 1.5 x upper limit of normal

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test

• Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last weekly veltuzumab infusion.

• Primary CNS lymphoma, HIV lymphoma or transformed lymphoma, or presence of symptomatic CNS metastases or carcinomatous meningitis.

• Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter

• Disease status eligible for potentially curative external beam radiation (stage 1 or contiguous stage 2 at sites appropriate for radiotherapy)

• Bone marrow involvement ≥25%; patients with CLL

• Pleural effusion with positive cytology for lymphoma

• Patients known to be HIV positive or hepatitis B positive

• Corticosteroid use within 2 weeks, unless 20 mg/day or less at stable dose.

• Prior malignancy with less than a 1-year disease-free interval, excluding non-melanoma skin cancers and carcinoma in situ of the cervix.

• Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations