Veltuzumab and Milatuzumab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Completed · Phase 1/Phase 2

Conditions studied: Lymphoma

In brief

A phase I dose escalation study of veltuzumab and milatuzumab in relapsed and refractory B-cell NHL. The phase I study will be followed by a pilot phase II study.

Key facts

Study ID

NCT00989586

Run by

Beth Christian

People needed

35

Starts

2009-09-01

Expected to finish

2015-09-01

Last updated by the study team

2017-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed B-cell non-Hodgkin lymphoma (NHL), including any of the following:
• Marginal zone lymphoma
• Waldenstrom macroglobulinemia (lymphoplasmacytic lymphoma)
• Follicular lymphoma
• Mantle cell lymphoma
• Relapsed or refractory disease after ≥ 1 prior therapy
• Patients with rituximab-refractory disease (defined as having less than a partial response to the prior rituximab-containing regimen) or rituximab-sensitive disease (defined as having a complete response or partial response to the last rituximab-containing regimen [provided it has been ≥ 3 months since the last dose of rituximab]) are eligible.
• Age >18 years.
• Eastern Cooperative Oncology Group (ECOG)performance status 0-2.
• Patients must have normal organ and marrow function as defined below:
• Absolute neutrophil count ≥ 1000/μL
• Platelets ≥ 75,000/μL
• Total bilirubin ≤ 2.0 X institutional upper limit of normal
• AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal
• Creatinine ≤ 2.0 mg/dL
• Patients who have relapsed after stem cell transplant are eligible for this trial.
• Patients with active Hepatitis B infection are not eligible.
• Non-pregnant and non-nursing. Women of child bearing potential and men must agree to use contraception prior to study entry and for duration of study participation.
• Must possess the ability to understand and the willingness to sign a written informed consent document.
• Phase II
• Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension >10 mm or in the case of Waldenstrom's macroglobulinemia, the presence of an IgM paraprotein level 2x the upper limit of normal.

You may not qualify if…

• Must be recovered from all toxicities from prior therapy or radiation (excluding alopecia).
• No known CNS lymphoma.
• History of documented human anti-globulin antibodies.
• No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations.
• HIV-positive patients.
• Pregnant women.
• Patients with secondary malignancies with exception of non-melanomatous skin cancers.

Where it is running

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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