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Phase I/II Study of Subcutaneously Administered Veltuzumab (ha20) in Patients with CD20+ Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukemia
|Leukemia, Chronic Lymphocytic (CLL)
|Lymphoma, Non - Hodgkin
- Primary Objective
- To document the safety, tolerance and lack of immunogenicity of veltuzumab with this subcutaneous administration schedule and dosing.
- Secondary Objectives
- To assess pharmacokinetics (PK), pharmacodynamics (PD), and evidence of efficacy with this subcutaneous administration schedule and dosing.
- Histologically confirmed diagnosis of CD20 positive follicular, small lymphocytic lymphoma or marginal zone non-Hodgkin’s lymphoma or chronic lymphocytic leukemia (CLL). (Note: the revised protocol is restricted exclusively to patients with CLL.)
- Either previously untreated or relapsed. In the European Union only, previously untreated patients must also be > 60 years of age.
- Measurable disease (at least one lesion ≥ 1.5 cm for NHL, or Absolute Lymphocyte Count > 5,000 for CLL).
- Relapsed patients must be 12 months beyond any prior rituximab treatment, 12 weeks beyond autologous stem cell transplant.
- Patient has not had major surgery, or received anti-cancer therapy (chemotherapy or immunotherapy or other experimental therapies or any radiation therapy to the index lesion(s) within 4 weeks with no persistent Grade 3 toxicity from prior therapy.
- Screened for hepatitis B (no time limit) and negative by tests included in NCCN guidelines (hepatitis B surface antigen/antibodies, core antigen/antibodies, hepatitis B e-antigen).
- Male or female, age > 18 years.
- Adequate performance status (≥70 Karnofsky scale, 0-1 ECOG) with an estimated life expectancy of at least 6 months
- Laboratory parameters:
- Adequate hematology without ongoing transfusional support
- Hemoglobin ≥ 8 g/dL
- Absolute neutrophil count ≥ 1.0 x 109/L
- platelets ≥ 50 x 109/L
- Creatinine and bilirubin ≤ 1.5 x IULN
- AST and ALT ≤ 2.5 x IULN
- Patients of childbearing potential must be willing to practice birth control during the study until at least 12 weeks after last veltuzumab infusion; women of childbearing potential must have a negative urine or serum pregnancy test to enter the study.
- Signed IRB-approved informed consent.
- Previously untreated NHL patients with Stage I and II disease (Ann Arbor classification)
- Previously untreated CLL patients with Stage 0-2 disease (Rai classification) unless specific treatment indications by NCCN guidelines exist (symptomatic, recurrent infections, end-organ function, cytopenias and steady disease progression).
- Relapsed patients receiving more than 4 prior treatment regimens.
- Known central nervous system (CNS) involvement by lymphoma, HIV lymphoma, transformed lymphoma (Richter’s lymphoma)
- Prior malignancies (other than non-melanoma skin cancer or carcinoma in situ of the cervix) unless disease free for 5 years.
- Patients who have pleural effusion with positive cytology for lymphoma
- Rituximab resistant, defined as having progressed during or within 6 months of rituximab treatment.
- Excessive toxicity to rituximab (NCI CTC Grade 3 or 4) or known to be HACA positive
- Therapy with other human or humanized monoclonal antibodies (unless HAHA tested and negative).
- Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter
- Known HIV positive or active hepatitis B or C, or presence of hepatitis B surface antigens or presence of hepatitis C antibody
- Known autoimmune disease or presence of autoimmune phenomena
- Patient is pregnant or nursing
- Patient is receiving other investigational drugs at least 7 days beyond any infection or requiring antibiotic use.
- Use of systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, ≤20 mg/day, or equivalent) which may continue if unchanged.
- 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.
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