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Phase II Multicenter Study of Iodine-131 Anti-B1 Antibody Consolidation For Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Following First-Line CHOP

Phase 2
18 Years
80 Years
Open (Enrolling)
Non-Hodgkin's Lymphoma

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Trial Information

Phase II Multicenter Study of Iodine-131 Anti-B1 Antibody Consolidation For Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Following First-Line CHOP

The primary endpoint is to determine the incidence of Grade IV hematologic toxicity
following Iodine-131 Anti-B1 Antibody consolidation for patients with diffuse large B-cell
NHL who achieved a response (PR, CRu, CR) following first-line CHOP chemotherapy. The
secondary efficacy endpoints are to determine the complete response rate, duration of
response, duration of complete response, progression-free survival, and time to treatment
failure. The pharmacokinetic endpoint is to determine the total body residence time
following the dosimetric dose. The secondary safety endpoints are to determine the
incidence of adverse experiences, hematologic toxicity (e.g., nadir, time to nadir, and time
to recovery), use of supportive care, percent of patients converting to human anti-murine
antibody (HAMA) positivity, and survival.

Inclusion Criteria:

- Patients must have a histologically confirmed initial diagnosis of de novo diffuse
large B-cell NHL according to the REAL classification. This includes the
intermediate grade International Working Formulation subtypes of diffuse, mixed small
cell and large cell; diffuse large cell; follicular large cell; mantle cell, and
large cell immunoblastic.

- Patients must have had Ann Arbor, stage III or stage IV, or bulky Stage II disease at

- Patients must be less than or equal to 80 years of age with any IPI score.

- Patients must have less than an average of 25% of the intratrabecular marrow space
involved by NHL in bilateral bone marrow biopsy specimens as assessed microscopically
at study entry. A unilateral bone marrow biopsy demonstrating <10% involvement with
NHL is also adequate. Verification of bone marrow status must be performed at the
time of response evaluation following CHOP chemotherapy and within 56 days of study

- Patients must have been treated with 6 or more cycles of first-line CHOP chemotherapy
and have achieved a PR, CRu, or CR. Patients must have available computed tomography
(CT) scans of the chest, abdomen, and pelvis, and a bone marrow biopsy that were
performed within 56 days prior to the start of CHOP. In addition, they must have
written documentation (i.e., copies of original medical notes and radiographic
reports) describing the pre-CHOP staging evaluation, the number of cycles of CHOP
administered, the dose of each agent, the start and stop dates of each cycle, and the
post-CHOP response evaluation. The post-CHOP response evaluation must include a CT
scan of the chest, abdomen, and pelvis (gallium scan is optional). For patients who
have palpable cervical lymphadenopathy, a CT scan of the neck must be performed
following CHOP chemotherapy. The CHOP chemotherapy should consist of standard doses
of each agent, although dose-reduction is permitted. CHOP cycle delay is also

- The patient must be enrolled within 56 days of the first day of the last cycle of
CHOP chemotherapy and within 35 days following response evaluation after CHOP

- Patients must have evidence that their tumor tissue expresses the CD20 antigen.

- Patients must have a performance status of at least 60% on the Karnofsky Performance
Scale and an anticipated survival of at least 3 months.

- Patients must have an ANC greater than or equal to 1500 cells/mm3 and a platelet
count greater than or equal to 100,000 cells/mm3 within 14 days of study enrollment.
These blood counts must be sustained without support of hematopoietic cytokines or
transfusion of blood products.

- Patients must have adequate renal function (defined as serum creatinine <1.5 times
the upper limit of normal) and hepatic function (defined as total bilirubin less than
or equal to 2.0 times the upper limit of normal and AST <5 times the upper limit of
normal) within 20 days of study enrollment.

- Patients of childbearing potential must undergo a negative serum pregnancy test
within 14 days prior to study enrollment

Exclusion Criteria:

- Patients who have received prior chemotherapy other than first-line CHOP. Patients
must not have been treated with radiation, or biological therapy prior to or after
CHOP chemotherapy.

- Patients with active bilateral obstructive hydronephrosis.

- Patients with New York Heart Association class III or IV heart disease or other
serious illness that would preclude evaluation.

- Patients with prior malignancy other than lymphoma, except for adequately treated
skin cancer, in situ cervical cancer, or other cancer for which the patient has been
disease-free for 5 years. Patients who have been disease-free of another cancer for
greater than 5 years must be carefully assessed at the time of study enrollment to
rule out recurrent disease.

- Patients with known HIV infection.

- Patients who are HAMA positive.

- Patients with known brain or leptomeningeal metastases at any time since diagnosis.

- Patients with active infection requiring IV anti-infectives at the time of study

- Patients who are pregnant or breastfeeding. Males and females must agree to use a
contraceptive method from enrollment to 6 months after receiving Iodine-131 Anti-B1

Type of Study:


Study Design:

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


United States: Food and Drug Administration

Study ID:




Start Date:

January 2000

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Radioimmunotherapy
  • Monoclonal Antibody
  • Corixa
  • Bexxar
  • Anti-B1 Antibody
  • Tositumomab
  • Iodine -131 Anti-B1 Antibody
  • Iodine I 131 Tositumomab
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



Rush Medical Center Chicago, Illinois  60612
Cornell Medical Center New York, New York  10021
Tufts New England Medical Center Boston, Massachusetts  02111