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IMDC 1910   |   CC00051
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
Main Campus
Phase 1
Phase 2
Veltuzumab (ha20)

Contact Information
Cancer Answer Line


8:00 am - 4:30 pm, Monday - Friday

  1. Primary Objective
    • To document the safety, tolerance and lack of immunogenicity of veltuzumab with this subcutaneous administration schedule and dosing.
  2. Secondary Objectives
    • To assess pharmacokinetics (PK), pharmacodynamics (PD), and evidence of efficacy with this subcutaneous administration schedule and dosing.

Inclusion Criteria
  1. 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.)
  2. Either previously untreated or relapsed. In the European Union only, previously untreated patients must also be > 60 years of age.
  3. Measurable disease (at least one lesion ≥ 1.5 cm for NHL, or Absolute Lymphocyte Count > 5,000 for CLL).
  4. Relapsed patients must be 12 months beyond any prior rituximab treatment, 12 weeks beyond autologous stem cell transplant.
  5. 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.
  6. 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).
  7. Male or female, age > 18 years.
  8. Adequate performance status (≥70 Karnofsky scale, 0-1 ECOG) with an estimated life expectancy of at least 6 months
  9. 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
  10. 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.
  11. Signed IRB-approved informed consent.

Exclusion Criteria
  1. Previously untreated NHL patients with Stage I and II disease (Ann Arbor classification)
  2. 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).
  3. Relapsed patients receiving more than 4 prior treatment regimens.
  4. Known central nervous system (CNS) involvement by lymphoma, HIV lymphoma, transformed lymphoma (Richter’s lymphoma)
  5. Prior malignancies (other than non-melanoma skin cancer or carcinoma in situ of the cervix) unless disease free for 5 years.
  6. Patients who have pleural effusion with positive cytology for lymphoma
  7. Rituximab resistant, defined as having progressed during or within 6 months of rituximab treatment.
  8. Excessive toxicity to rituximab (NCI CTC Grade 3 or 4) or known to be HACA positive
  9. Therapy with other human or humanized monoclonal antibodies (unless HAHA tested and negative).
  10. Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter
  11. Known HIV positive or active hepatitis B or C, or presence of hepatitis B surface antigens or presence of hepatitis C antibody
  12. Known autoimmune disease or presence of autoimmune phenomena
  13. Patient is pregnant or nursing
  14. Patient is receiving other investigational drugs at least 7 days beyond any infection or requiring antibiotic use.
  15. Use of systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, ≤20 mg/day, or equivalent) which may continue if unchanged.
  16. 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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