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BEAM + 131Iodine-Anti-B1 Radioimmunotherapy and Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Recurrent Non-Hodgkin's Lymphoma

Phase 1
19 Years
70 Years
Open (Enrolling)

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Trial Information

BEAM + 131Iodine-Anti-B1 Radioimmunotherapy and Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Recurrent Non-Hodgkin's Lymphoma

Thirty patients will be enrolled in this study. There will be two administrations of
131I-anti-B1 given to patients, the "dosimetric dose" and the "radioimmunotherapy dose".
The dosimetric dose will consist of an infusion of unlabeled Anti-B1 (450 mg) immediately
followed by an infusion of Anti-B1 (35 mg) which has been trace labeled with 5mCi of
131I-anti-B1. The total whole body dosimetry dose is then calculated over an approximated
one-week time interval from the radioactive clearance data obtained by the Whole Body
anterior and posterior gamma camera scans. Based upon dosimetric data calculations specific
for each individual patient, a radioimmunotherapy dose will be given consisting of an
infusion of unlabeled Anti-B1 (450 mg)immediately followed by an infusion of 35 mg Anti-B1
including a patient specific dose of 131Iodine-Anti-B1. Calculations will be made such that
in a dose escation study, whole body radiation doses of 30, 45, 60, and 75cGy will result
from the administration of the therapeutic activity of 131I-anti-B1. The amount of the
unlabeled Anti-B1 administered is not calculated on a body surface area basis, but is given
to provide an excess of Anti-B1 independent of tumor burden, splenic uptake, or other

Inclusion Criteria:

- Pts with a diagnosis of indolent or aggressive B-cell non-Hodgkin's lymphoma who have
failed > 3 prior therapies, or are chemo resistant or refractory. Patients must be
otherwise eligible for high-dose therapy with the BEAM protocol and ABMT or PSCT.

- Pts without evidence of severe organ dysfunction.

- The pre-transplant bone marrow biopsy must show no evidence of marrow involvement if
an autologous BMT is to be performed and adequate cellularity, alternatively
autologous PSCT will be considered if the bone marrow involvement is <25%.

- The pt must have no other major medical problems and specifically life expectancy
must be at least 4 months post transplant, with a performance status Karnofsky score
of >70.

- Pts with evidence that their tumor tissue expresses the CD20 antigen.
Immunoperoxidase stains of tissue showing positive reactivity with L26 antibody or
flow cytometry studies are acceptable evidence of CD20 positivity. Testing of tumor
tissue from any time in the course of the patient's disease is acceptable.

- Pts must have normal renal function (creatinine < 2.0 mg/dL) and hepatic function
(bilirubin < 2.0 mg/dL) within seven days of study entry.

- Pts with DLCO >50% of predicted.

- If pt is >60 years or has a significant cardiac history (MI or CHF) or has received
>350 mg/m2 of Adriamycin and ejection fraction must be >40%.

- Pts must give written informed consent and sign an approved informed consent form
prior to study entry.

- ts must have bidimensionally measurable disease.

- Females of child-bearing potential must have a negative serum pregnancy test prior to
enrollment to the study, followed by the use of an effective method of birth control.

Exclusion Criteria:

- Pts with more than 25% of the intratrabecular marrow space involved by lymphoma in a
unilateral bone marrow biopsy specimens as assessed microscopically prior to study

- Pts who have received cytotoxic chemotherapy, radiation therapy or immunosuppressants
within THREE weeks prior to the radioimmunoconjugate dose or who exhibit persistent
clinical evidence of toxicity. The use of steroids must have been discontinued
(except maintenance-dose steroids).

- Pts with obstructive hydronephrosis.

- Pts with evidence of active infection requiring intravenous antibiotics at the time
of study entry.

- Pts with New York Heart Association class 3 or 4 heart disease or other serious
illness that would preclude evaluation.

- Pts with prior malignancy other than lymphoma, except for adequately treated skin ca,
in situ cervical ca, or other ca for which patient has been disease-free for 5 years.

- Pts with known HIV infection.

- Pts with known brain or leptomeningeal metastases.

- Pts who are pregnant. Patients of child-bearing potential must undergo a pregnancy
test. Males and females must agree to use effective contraception during the study
and females must continue effective contraception for one year following the
radioimmunotherapy dose.

- Pts with previous allergic reactions to iodine. This does not include IV contrast

- Pts who previously received radioimmunotherapy.

- Pts with progressive disease in a field that has been previously irradiated with more
than 3500 cGy within the past year.

- Pts who are on another protocol involving non-FDA approved drugs or biologics.

- No vulnerable subjects will be entered into this study.

- Pts with a positive HAMA test at baseline will not be entered. Patients with a
positive HAMA test at the end of the week following dosimetric dose administration
may not continue on to receive the radioimmunotherapy dose without first contacting
the FDA.

- Pts who have not harvested a minimum CD34+ count of 1.5 X 10 6/kg body weight or
CFU-GM count of >2.5 X 10 4/kg may not continue onto receive the study treatment.

- Pts with prior HSCT following high-dose chemo or chemo/radiotherapy.

Type of Study:


Study Design:

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

Outcome Measure:

Safety of 131I-anti-B1 radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy & HSCT

Outcome Time Frame:

During treatment

Safety Issue:


Principal Investigator

Julie M Vose, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska


United States: Food and Drug Administration

Study ID:




Start Date:

March 1996

Completion Date:

December 2015

Related Keywords:

  • Lymphoma
  • NHL
  • Non Hodgkins Lymphoma
  • 131Iodine-Anti-B1 Radioimmunotherapy
  • Autologous Hematopoietic Stem Cell Transplant
  • Lymphoma
  • Lymphoma, Non-Hodgkin



University of Nebraska Medical Center Omaha, Nebraska  68198-3330