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Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized IMMU-LL2: Treatment With 90Y-hLL2 IgG

Phase 1/Phase 2
18 Years
Not Enrolling
NHL, B-Cell NHL, Non-Hodgkins Lymphoma

Thank you

Trial Information

Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized IMMU-LL2: Treatment With 90Y-hLL2 IgG

90Y-labeled hLL2 will be administered according to a schedule based upon whether or not a
patient had prior high-dose chemotherapy with a marrow or stem cell transplant. Patients
with both indolent and aggressive types of NHL will be enrolled at each dose level without
segregation. However, at the conclusion of the trial, with the maximum tolerated dose (MTD)
defined, a minimum number of 6 patients with indolent NHL, 6 patients with aggressive NHL,
and 6 patients with >25% bone marrow involvement will be studied at that dose level.

Inclusion Criteria:

- All patients must have a histologic or cytological diagnosis of B-cell lymphoma, and
have failed at least one regimen of standard chemotherapy. All histologic grades of
non-Hodgkin's lymphoma (NHL) will be eligible for these studies.

- Patients must be > 18 years of age

- Measurable disease by CT, with at least one lesion > 1.5 cm in one or both dimensions

- less than 25% bone marrow involvement as determined by bone marrow biopsy

- Patient must have greater than 15% cellularity of the bone marrow.

- Patients must be at least 4 weeks beyond any major surgery.

- Patients must be at least 4 weeks beyond any radiation therapy to the index lesion
and must have recovered from radiation induced toxicity.

- Patients must be at least 4 weeks beyond prior chemotherapy and/or immunotherapy, or
2-weeks after corticosteroids, and their blood counts must be within the eligibility
criteria. Corticosteroids may, however, be given concomitantly if used to treat
adrenal insufficiency

- Patients must have a performance status of 70 or greater on the Karnofsky scale
equivalent to ECOG 0-1 (See Appendix A) and a minimal life expectancy of 6 months.

- Patients must be able to give cognizant informed consent.

Exclusion Criteria:

- Patients with a significant concurrent medical complication including severe
anorexia, nausea or vomiting that in the judgement of the Investigator could affect
the patient's ability to tolerate or complete this study.

- Patients with metastasis to the brain.

- Patients with extensive irradiation to more than 25% of their red marrow will be
excluded, except those who had total body irradiation in the context of bone marrow
or stem cell transplantation regimen with subsequent engraftment of a functional
marrow (i.e., resulting in normal peripheral blood counts). Subjects who have
received external radiation to specific organs or areas at the maximum tolerated
level are also excluded.

- Women who test positive for pregnancy.

- Patients with splenomegaly.

- Patients with > 4 treatment regimens prior to this protocol, including chemotherapy,
radiotherapy and/or other immunotherapy.

- Patients with prior radioimmunotherapy treatments (unless for retreatment under this

- Patients receiving rituximab within 3 months, unless progressing after treatment.

- Patients with <50% LVEF by required MUGA or 2-D ECHO.

- Patients with <60% of predicted value by required pulmonary function tests.

- Patients who have active Hepatitis B or C or are known HIV positive.

- Patients with another primary malignancy (except basal/squamous cell carcinoma of the
skin or carcinoma in-situ of the cervix.

- Patients with other serious medical, surgical, or psychiatric history, unless
currently stable and well controlled, without significant increase in treatment
medications for at least 30 days preceding study entry.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety will be evaluated from physical examinations, hematology and chemistry testing and toxicity evaluation

Outcome Time Frame:

First 12 weeks, total 5 years

Safety Issue:


Principal Investigator

William A Wegener, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Immunomedics, Inc.


Germany: Paul-Ehrlich-Institut

Study ID:




Start Date:

August 2002

Completion Date:

October 2007

Related Keywords:

  • NHL
  • B-Cell NHL
  • Non-Hodgkins Lymphoma
  • NHL
  • B-cell NHL
  • Non-Hodgkins lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin