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A Phase I/II Study of Veltuzumab (IMMU-106, hA20), a Humanized Anti-CD20 Monoclonal Antibody, Combined With Milatuzumab (IMMU-115, hLL1), a Humanized Anti-CD74 Monoclonal Antibody, in Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma

Phase 1/Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase I/II Study of Veltuzumab (IMMU-106, hA20), a Humanized Anti-CD20 Monoclonal Antibody, Combined With Milatuzumab (IMMU-115, hLL1), a Humanized Anti-CD74 Monoclonal Antibody, in Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma

A phase I/II study of veltuzumab combined with milatuzumab in relapsed and refractory
non-Hodgkin's lymphoma. Both agents are well-tolerated in early phase clinical testing with
infusion reactions as the primary observed toxicity. Preclinical testing in vitro and in
vivo have demonstrated single agent activity for both veltuzumab and milatuzumab. In mantle
cell lymphoma cell lines and SCID mouse models, synergist effects were observed when
milatuzumab was combined with rituximab. Veltuzumab has several advantages over rituximab
including slower off-rates, shorter infusion times, higher potency, and improved therapeutic
responses in animal models. Previous and ongoing clinical investigations support the concept
of combining monoclonal antibodies in NHL.

Inclusion Criteria:

- Histologically confirmed B-cell non-Hodgkin lymphoma (NHL), including any of the

- 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.

Exclusion Criteria:

- Must be recovered from all toxicities from prior therapy or radiation (excluding

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine dose limiting toxicity (DLT)and maximum tolerated dose (MTD)for phase I and overall response rate for phase II along with defining toxicities for the combination.

Outcome Time Frame:

up to 2 years

Safety Issue:


Principal Investigator

Beth Christian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent mantle cell lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • Waldenstrom macroglobulinemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



Ohio State University Comprehensive Cancer Center Columbus, Ohio