Know Cancer

or
forgot password

Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin

Thank you

Trial Information

Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies


Inclusion Criteria:



- Male and female subjects ≥18 years of age with histologically confirmed at initial
diagnosis, previously treated (at least 2 prior chemotherapy regimens), low-grade NHL
or low-grade lymphoma that had transformed to intermediate- or high-grade histology.

Exclusion Criteria:

- Subjects with more than an average of 25% of the intratrabecular marrow space
involved by lymphoma in bone marrow biopsy specimens as assessed microscopically
within 42 days of study entry. Bilateral posterior iliac crest core biopsies are
required if the percentage of intratrebecular space involved exceeds 10% in a
unilateral biopsy. The mean of bilateral biopsies must be no more than 25%.

- Cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment
within 4 weeks prior to study entry or persistent clinical evidence of toxicity.

- Prior stem cell transplant.

- Active obstructive hydronephrosis.

- Evidence of active infection requiring intravenous (IV) antibiotics at the time of
study entry.

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

- Prior malignancy other than lymphoma, except for adequately treated skin cancer, in
situ cervical cancer, or other cancer for which the subject has been disease-free for
5 years.

- Known HIV infection.

- Known brain or leptomeningeal metastases.

- Subjects who are pregnant or nursing.

- Previous allergic reactions to iodine. This does not include reactions to intravenous
iodine-containing contrast materials.

- Prior exposure to monoclonal or polyclonal antibodies of any non-human species for
either diagnostic or therapeutic purposes, including engineered chimeric and
humanized antibodies.

- Prior radioimmunotherapy.

- Progressive disease within 1 year of irradiation arising in a field that has been
previously irradiated with >3500 cGy.

- Current use of either approved or non-approved (through another protocol) anti-cancer
drugs or biologics

- De novo intermediate- or high-grade lymphoma.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants (Par.) Receiving TST and I 131 TST With a Response >=30 Days Versus Par. With a Response >=30 Days After Their Last Qualifying Chemotherapy Regimen (LQCR), Masked Independent Randomized Radiology and Oncology Review (MIRROR) Panel

Outcome Description:

Par. with response are those with complete response (CR; complete resolution of all disease-related radiological abnormalities and the disappearance of all signs/symptoms related to disease), complete response unconfirmed (CRu; meets characteristics of CR, except the nodal size hasn't regressed sufficiently, or there is indeterminate bone marrow), or partial response (PR; >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions). Participants' LQCR was used as a comparator for subsequent treatment with Iodine I 131TST.

Outcome Time Frame:

Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

104504

NCT ID:

NCT00989664

Start Date:

November 1996

Completion Date:

September 2008

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • non-Hodgkin's Lymphoma
  • radioimmunotherapy
  • NHL
  • Bexxar
  • lymphoma
  • Tositumomab
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location